Instructions

Instructions for Pre-Transplant Essential Data (Pre-TED) Form
(Revision 4)
This section of the CIBMTR Forms Instruction Manual is intended to be a resource for
completing the Pre-Transplant Essential Data (Pre-TED) Form (Revision 4).
Effective December 3, 2007, the Pre- and Post-TED forms replaced the former PreRegistration (Pre-Reg), Transplant Essential Data (TED), Modified TED (M-TED) and
TED Follow-up (TEDFU) registration forms.
E-mail comments regarding the content of the CIBMTR Forms Instruction Manual to:
[email protected]. Comments will be considered for future
manual updates and revisions. For questions that require an immediate response,
please contact your transplant center’s CIBMTR CRC.

TABLE OF CONTENTS
Key Fields ............................................................................................................ 3
CIBMTR USE ONLY............................................................................................ 4
Recipient Data ..................................................................................................... 4
Hematopoietic Cellular Transplant (HCT) ............................................................ 6
Donor Information .............................................................................................. 10
Consent ............................................................................................................. 18
Product Processing/Manipulation ...................................................................... 21
Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning) .... 22
Comorbid Conditions ......................................................................................... 25
Pre-HCT Preparative Regimen (Conditioning) .................................................. 29
GVHD Prophylaxis............................................................................................. 35
Other Toxicity Modifying Regimen ..................................................................... 36
Post-HCT Disease Therapy Planned as of Day 0 ............................................. 36
Primary Disease for HCT ................................................................................... 37
Acute Myelogenous Leukemia (AML) ................................................................ 39
Acute Lymphoblastic Leukemia (ALL) ............................................................... 51
Other Acute Leukemia ....................................................................................... 60
Chronic Myelogenous Leukemia (CML) ............................................................ 62
Myelodysplastic (MDS)/Myeloproliferative (MPN) Diseases .............................. 66
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Other Leukemia (OL) ......................................................................................... 80
Hodgkin Lymphoma........................................................................................... 85
Non-Hodgkin Lymphoma ................................................................................... 88
Multiple Myeloma/Plasma Cell Disorder (PCD) ................................................. 92
Solid Tumors ................................................................................................... 104
Severe Aplastic Anemia .................................................................................. 105
Inherited Abnormalities of Erythrocyte Differentiation or Function ................... 105
Disorders of the Immune System .................................................................... 105
Inherited Abnormalities of Platelets ................................................................. 105
Inherited Abnormalities of Metabolism............................................................. 105
Histiocytic Disorders ........................................................................................ 106
Autoimmune Diseases..................................................................................... 106
Other Disease ................................................................................................. 106
Signature ......................................................................................................... 106

Pre-Transplant Essential Data (Pre-TED)
The Pre-TED Form is now required for all transplants, including subsequent
transplants on the comprehensive report form track.
All transplant centers participating in the CIBMTR must submit a Pre-TED Form for
each allogeneic (related or unrelated) hematopoietic cell transplant (HCT). The Pre-TED
is a requirement of the SCTOD for all United States transplant centers when either the
stem cell donation or the transplant occurs within the United States. For more
information regarding the SCTOD, see General Instructions, Stem Cell Therapeutics
Outcomes Database.
Although data regarding recipients receiving autologous HCT are not required to be
submitted as part of the C.W. Bill Young Transplant Program, the CIBMTR is highly
committed to collecting data on these recipients for research studies. Centers choosing
to report autologous data to the CIBMTR must report on all autologous transplants
performed at their center. For more information regarding data reporting for autologous
HCT, see General Instructions, Autologous Hematopoietic Stem Cell Transplant.
The Pre-TED may be submitted to the CIBMTR up to two weeks prior to the start of the
recipient’s preparative regimen (see Helpful Hint below). The Pre-TED is due the day of
the HCT (day 0), and is past due if not received by that date.

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Helpful Hint:
In order to avoid having to make changes to the HCT date, complete the data for the
Pre-TED (in FormsNet3SM or on paper), but do not submit the form until the first dose of
the preparative regimen is given.
For recipients receiving a subsequent HCT:
Transplant centers must submit a Pre-TED for all subsequent HCTs; this includes
recipients assigned to the TED Forms and the Comprehensive Report Forms by the
form selection algorithm.
For the majority of subsequent HCTs, the recipient will remain on the original follow-up
form track assigned by the form selection algorithm. For more information regarding
center type and the form selection algorithm, see General Instructions, Center Type and
Data Collection Forms. A recipient may need to change tracks if enrolled on a study that
requires comprehensive forms.
For recipients of multiple transplants, transplant centers are not granted access to the
new Pre-TED Form in FormsNet3SM until the Post-TED or Form 2100/2200/2300 from
the previous transplant has been completed.
Transplant centers can use the FormsNet3SM application to determine if a Pre-TED is
due by either: 1) accessing the Forms Due Report, or 2) entering the recipient’s unique
ID (CRID) in the Patient Forms Due field.

Key Fields
Accuracy of the Key Fields is essential for ensuring that:
Data are being reported for the correct recipient.
Outcomes data accurately reflect appropriate transplant type and product for
each transplant center.
Data are being shared with the correct donor center, cord blood bank,
cooperative registry, or other agency.
The Key Fields precede the form body and are automatically populated in the
FormsNet3SM application based on information provided on the CRID Assignment Form
2804. If errors are noted in the key fields, correct Form 2804 and then review it for
accuracy. After Form 2804 has been corrected, verify data has been updated on all
completed forms. If the data has not been updated automatically, centers will need to
reprocess the completed forms to correct the key field data. If errors are noted in key
fields for second or subsequent transplants, contact your CRC to make any necessary
corrections to the transplant or product type. Transplant and product type will not be
automatically populated on product- or donor-specific forms (Forms 2004, 2005, and
2006) and will need to be manually reported.
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CIBMTR USE ONLY
This box appears only on the paper version of the form and is intended for CIBMTR use
only. This box does not appear in the FormsNet3SM application.
Do not write in this box.

Recipient Data
Question 1: Date of Birth
The date of birth is automatically populated based on the value reported on the CRID
Assignment Form (2804). Verify that the date of birth is correct. If an error is noted,
correct Form 2804 and verify that the date of birth has been updated on the Pre-TED
Form.
Question 2: Sex
The recipient’s sex is automatically populated based on the value reported on the CRID
Assignment Form (2804). Verify that the recipient’s sex is correct. If an error is noted,
correct Form 2804 and verify that the recipient’s sex has been updated on the Pre-TED
Form.
Question 3: Ethnicity
Indicate the recipient’s ethnicity. The United States Office of Management and Budget
(OMB) has defined ethnicity as culturally or geographically determined. The distinction
between Hispanic and non-Hispanic is for the purpose of the United States census and
reporting of SCTOD data. According to the OMB, “Hispanic” is an ethnic designation
based upon where someone (his or her ancestors) was raised (e.g., “Latin America”).
Hispanic people may be of any race. The CIBMTR recognizes regional differences with
regard to the interpretation of ethnicity throughout the world.
If the recipient is not a resident of the USA, select “not applicable.”
If the recipient declines to provide this information or the recipient’s ethnicity is not
documented, select “unknown.”
For more information regarding ethnicity, see Appendix I.
NOTE: Question 4, reporting more than one race
FormsNet3SM application: Complete question 4 for each race the recipient identifies
with by adding an additional instance in the FormsNet application.
Paper form submission: Copy question 4 and complete for each race the recipient
identifies with.

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Question 4: Race
Indicate the recipient’s race. If this recipient has reported that they are more than one
race, you may indicate each race by adding an additional instance in the FormsNet
application. The race groups provided are specific to the United States.
For non-U.S. centers, select “not reported” if the rules/regulations of your country
prohibit the collection or reporting of race data (or due to lack of documentation). If race
is reported, it may be necessary to consult with the recipient to select the race group(s)
with which they most closely identify.
If the recipient declines to provide this information, select “not reported.”
If the recipient’s race is not documented, select “unknown.”
For more information regarding race, see Appendix I.
Question 5: ZIP or postal code for place of recipient’s residence (USA recipients
only)
Enter the ZIP code in which the recipient resides.
Question 6: Is the recipient participating in a clinical trial?
Indicate if the recipient is a registered participant with BMT-CTN, RCI-BMT, USIDNET,
COG, and/or another clinical trial sponsor that uses CIBMTR forms to capture outcomes
data. If “yes,” continue with question 7. If “no,” continue with question 11.
BMT-CTN: Blood and Marrow Transplant Clinical Trials Network
RCI-BMT: Resource for Clinical Investigation in Blood and Marrow Transplant
USIDNET: United States Immunodeficiency Network
COG: Children’s Oncology Group
NOTE: Questions 7-10 reporting participation in more than one study
FormsNet3SM application: Complete questions 7-10 for each study the recipient is
participating in by adding an additional instance in the FormsNet application.
Paper form submission: Copy questions 7-10 and complete for each study in which
the recipient is participating.
If the participant is enrolled in multiple studies, even if from the same sponsor, report
each study separately.
Questions 7-8: Study Sponsor
Select the study sponsor of the clinical trial the recipient is participating in.
If the study sponsor is reported as “BMT-CTN” or “RCI-BMT,” continue with question 9.
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If the study sponsor is reported as “USIDNET” or “COG,” continue with question 10.
If “other sponsor” is reported, specify the study sponsor in question 8 and continue with
question 10.
Question 9: Study ID Number
Select the recipient’s Study ID number.
Question 10: Subject ID
Enter the recipient’s USIDNET, COG, or other sponsor Subject ID.
If the recipient is participating in a BMT-CTN study and the EMMES ID is known, enter it
here.
If the recipient is participating in an RCI-BMT study, enter the Subject ID given at the
time of successful enrollment.

Hematopoietic Cellular Transplant (HCT)
Question 11: Date of this HCT
Report the intended start date of the HCT. If the infusion is planned to last several days,
enter the first day the infusion is scheduled to start.
If the Pre-TED was submitted prior to day 0, and the planned infusion date has
changed, the original planned date of the HCT will automatically be reported in
FormsNet3SM on either the Post-TED or the 100 Days Post-HCT Data Form (Form
2100). For the recipient’s first transplant, the HCT date may be changed on the Form
2804. For a subsequent transplant, the date may be changed on the form (Form
2100/2200/2300 or 2450) where the subsequent transplant was originally reported.
If the recipient is scheduled to receive a combination of cellular therapy and stem cell
infusions, contact your center’s CIBMTR CRC for reporting requirements.
Question 12: Was this the first HCT for this recipient?
Indicate if this is the recipient’s first transplant. First transplant is defined as the first
transplant the recipient ever receives, not the first transplant the recipient receives at
your facility.
If “yes,” and this is an autologous transplant, continue with question 13.
If “yes,” and this is an allogeneic transplant, continue with question 29.
If “no,” continue with question 15.

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Question 13: For autologous HCTs only: Is a subsequent HCT planned as part of
the overall treatment protocol (not as a reaction to post-HCT disease
assessment)?
If, at the time of the current HCT, a second (tandem transplant) or subsequent HCT is
planned according to the protocol, check “yes” even if the recipient does not receive the
planned subsequent HCT. The word “planned” should not be interpreted as: if the
recipient relapses, then the “plan” is to perform a subsequent HCT. If “yes,” continue
with question 14. If “no,” continue with question 29.
Question 14: Specify subsequent HCT planned:
Indicate whether the planned subsequent HCT is autologous or allogeneic and continue
with question 29.
Question 15: Specify the number of prior HCTs:
Enter the number of prior HCTs for the recipient. An HCT event is defined as an infusion
of mobilized peripheral blood stem cells (PBSC), bone marrow, or cord blood. For more
information on how to distinguish infusion types [example: HCT versus donor cellular
infusion (DCI)], see Appendix O.
For recipients who have received a previous HCT (prior to the HCT for which this form
is being completed), the following are examples of how to calculate the number of prior
HCTs.
Example 1:
A recipient was previously transplanted under a protocol that included an infusion
of cells over multiple days: day 0, day +1 and day +2. This series of infusions is
considered one HCT event (as opposed to three HCT events) and should be
counted as HCT Event #1.
After receiving the infusion, the recipient had relapse of disease. The recipient is
scheduled to receive a subsequent HCT including a preparative regimen. This
HCT is HCT Event #2.One prior HCT should be reported.
Example 2:
A recipient previously received an allogeneic HCT (HCT Event #1). Then, due to
delayed neutrophil recovery, the recipient received additional cryopreserved
allogeneic mobilized PBSC from the original donor, without a preparative
regimen (i.e., “boost” – HCT Event #2).
After receiving the boost, the recipient had relapse of disease. The recipient is
scheduled to receive a subsequent allogeneic HCT with preparative regimen
(HCT Event #3). Two prior HCTs should be reported.
Example 3:
A recipient previously received an autologous HCT (HCT Event #1). Then due
to delayed neutrophil recovery, the recipient received additional cryopreserved
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autologous cells without a preparative regimen (i.e., “boost” which is not
counted as an HCT event because the intent of the autologous infusion is to treat
the graft failure).
The boost is successful, but a few years later the recipient develops a new
malignancy. The recipient is scheduled to receive a subsequent autologous HCT
with preparative regimen (HCT Event #2). One prior HCT should be reported.
If the recipient receives an infusion due to poor graft response, count the infusion
as a subsequent HCT. The exception to this is “autologous rescue.” Autologous rescue
should not be counted as a separate HCT, and the data collection forms will not start
over (i.e., the forms will continue from the previous HCT).
Questions 16-19: What was (were) the prior HCT source(s)?
Select the cellular source for each of the recipient’s previous HCTs as either
autologous, allogeneic unrelated, allogeneic related, or syngeneic (identical twin).
Question 20: Date of the last HCT (just before current HCT):
Report the date of the recipient’s last autologous or allogeneic (related or unrelated)
HCT. Although the CIBMTR requests a Pre-TED for each HCT, there may be
circumstances where a prior HCT was not reported (e.g., prior autologous HCT or HCT
performed at another center). Reporting the recipient’s last HCT enables the CIBMTR to
appropriately account for recipient survival status in the database.
Question 21: Was the last HCT performed at a different institution?
Indicate if the last HCT was performed at another institution. If “yes” continue with
question 22. If “no” continue with question 23.
Question 22: Specify the institution that performed the last HCT:
Report the name, city, state, and country of the institution where the recipient’s last HCT
was performed. These data are used to identify and link the recipient’s existence in the
database and, if necessary, obtain data from the previous transplant center.
Question 23: What was the HSC source for the last HCT?
Report the stem cell source of the recipient’s last HCT as either autologous, allogeneic
unrelated or allogeneic related (including syngeneic).
Question 24-28: Reason for current HCT:
Indicate the reason for the current HCT (check only one). If this was a subsequent
transplant, verify that this answer is consistent with the reason for the subsequent
transplant reported on the previous series of report forms.
No hematopoietic recovery:
Additional stem cells are required because the recipient did not recover their
granulocytes following previous high-dose therapy and HCT.
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Partial hematopoietic recovery:
Additional stem cells are required because the recipient’s hematopoietic
recovery was deemed insufficient or too slow for the recipient to survive
following previous high-dose therapy and HCT (ANC was never greater than
or equal to 0.5 x 109/L for three consecutive days).
Graft failure/rejection after achieving initial hematopoietic recovery:
Additional stem cells are required because the recipient’s hematopoietic
recovery declined indefinitely after the initial hematopoietic recovery (ANC
was greater than or equal to 0.5 x 109/L for three consecutive days, and then
declined to below 0.5 x 109/L for three consecutive days). If the reason is graft
failure or rejection after initial recovery, also complete question 25.
Persistent primary disease:
Additional stem cells are required because the recipient was transplanted with
disease present, and never entered a remission following the previous
transplant.
Recurrent primary disease:
Additional stem cells are required because the disease for which the recipient
was transplanted relapsed following the previous transplant. If the reason is
recurrent primary disease, also complete question 26. Ensure that the date of
recurrent primary disease matches the relapse/progression date reported on
the previous transplant’s appropriate follow-up form.
Planned second HCT, per protocol:
Additional stem cells are given because the protocol planned for a
subsequent transplant/infusion. This includes all planned subsequent
transplants (including triple or quadruple transplants). This transplant is not
based upon recovery, disease status, or any other assessment.
New malignancy (including PTLD and EBV lymphoma):
Additional stem cells are required because the recipient has developed a new
malignancy. This does not include a transformation or progression of the
original malignancy for which the recipient was transplanted. If the reason is a
new malignancy, also complete question 27, and attach a copy of the
pathology report using the Log of Appended Documents (Form 2800). Ensure
that the date of diagnosis for the new malignancy matches the date of
diagnosis for the new malignancy reported on the previous transplant’s
appropriate follow-up form.
Stable, mixed chimerism:
Verify with the transplant physician that the cells given should be reported as
a subsequent transplant and that stable, mixed chimerism is the reason for
the transplant.
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Declining chimerism:
Additional stem cells are required because the percentage of donor cells
present versus recipient cells present is decreasing. This is usually due to an
underlying cause such as graft failure, graft rejection, or recurrent disease.
Other:
Additional stem cells are required and/or given for a reason other than the
options listed. If the HCT is for another reason, select “other” and complete
question 28.

Donor Information
Question 29: Multiple donors?
Indicate if cells from multiple different donors (multiple CBUs, combinations of other
products from different donors) are to be used for this HCT. If “yes,” continue with
question 30. If “no,” continue with question 31.
A supplemental infusion is defined as an infusion of cells given prior to clinical day 0 (of
an HCT) for any reason other than to produce engraftment. An infusion of supplemental
cells is often given in conjunction with a preparative regimen for HCT. Supplemental
infusions should be included when determining if multiple donors were used for this
HCT event.
For more information on supplemental infusions, see Appendix O.
Question 30: Specify number of donors
Report the number of donors used for this HCT. Note that this value should never be
“1,” since multiple donors were reported in question 29.
NOTE: Questions 31-62, reporting more than one donor
FormsNet3SM application: Complete questions 31-62 for each donor by adding an
additional instance in the FormsNet application.
Paper form submission: Copy questions 31-62 and complete for each donor.
Question 31: Specify donor
Indicate the donor type for this product.
An autologous product has cells collected from the recipient for his/her own use.
If the product was autologous (marrow, PBSC, other product), select
“autologous” and continue with question 46.
If the product was an autologous cord blood unit, select “autologous cord blood
unit” and continue with question 35.
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An unrelated donor (allogeneic, unrelated) is a donor who shares no known ancestry
with the recipient. Include adoptive parents/children or stepparents/children. Distinguish
if the product in an NMDP product or a non-NMDP product. Examples of non-NMDP
donor registries include, but are not limited to: St. Louis Cord Blood Bank, Anthony
Nolan, and StemCyte International Cord Blood Center.
If the product was an NMDP unrelated cord blood unit, select “NMDP unrelated
cord blood unit” and continue with question 32.
If the product was from an NMDP unrelated donor (marrow, PBSC, other
product), select “NMDP unrelated donor” and continue with question 33.
If the product was from a non-NMDP unrelated donor and was facilitated through
another registry, select “non-NMDP unrelated donor” and continue with question
34.
If the product was a non-NMDP cord blood unit, select “non-NMDP cord blood
unit” and continue with question 35.
A related donor (allogeneic or syngeneic, related) is a blood-related relative. This
includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, nonidentical) twins, siblings, parents, aunts, uncles, children, cousins, half-siblings, etc.
If the product was from a related donor (marrow, PBSC, other product), select
“related donor” and continue with question 40.
If the product was a related cord blood unit, select “related cord blood unit” and
continue with question 35.
Question 32: NMDP cord blood unit ID
Report the NMDP Cord Blood Unit ID. This information is included on the product label,
the paperwork accompanying the product, and within the NMDP search/product
documentation. The ID is always numeric and begins with “9” (e.g., 9000-0000-0). If the
product ID does not begin with a “9,” the product may not be an NMDP cord blood unit
and the source of the product should be double-checked. Enter the NMDP cord blood
unit ID and continue with question 46.
Question 33: NMDP donor ID
Report the NMDP Donor ID (e.g., 0000-0000-0). This ID is unique for each donor and is
assigned by NMDP. This information is included on the product label, the paperwork
accompanying the product, and within the NMDP search/product documentation. Enter
the NMDP Donor ID (e.g., 0000-0000-0) and continue with question 46.
Question 34: Non-NMDP unrelated donor ID (not applicable for related donors)
Report the non-NMDP unrelated donor ID. Examples of non-NMDP donor registries
include, but are not limited to: Anthony Nolan, Australia Bone Marrow Donor Registry,
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and REDOME. This ID is often located on the product label, the paperwork
accompanying the product, and registry-specific search/product documentation. Enter
the non-NMDP unrelated donor ID and continue with question 38.
Question 35: Non-NMDP cord blood unit ID (include related and autologous
CBUs)
Report the non-NMDP cord blood unit ID. Examples of non-NMDP donor registries
include, but are not limited to: St. Louis Cord Blood Bank and StemCyte International
Cord Blood Center. This ID is often located on the product label, the paperwork
accompanying the product, and registry-specific search/product documentation. Enter
the non-NMDP cord blood ID. Note that some cord blood banks can ship their units
either through the NMDP or directly to the transplant center. Carefully review the
accompanying documentation to determine which is appropriate for your unit. You may
wish to consult with your center's Transplant Coordinator, as he or she will have insight
as to how the product was acquired.
Question 36: Is the CBU ID also the ISBT DIN number?
Report “yes” if the non-NMDP CBU ID is the same as the International Society of Blood
Transfusion (ISBT) Donation Identification Number (DIN) and continue with question 38.
If the product has an ISBT label on it, the ISBT DIN number is in the upper-left-hand
corner and consists of a letter followed by 12 numbers, two sideways numbers, and a
letter in a box. Example below:

00

W0000 00 123456

A

Please find additional information regarding the ISBT DIN numbers and traceability at
http://www.iccbba.org/docs/public/introduction_traceability.pdf. For example, you may
see a barcode with an alphanumeric string below it.
If the CBU ID is not the same as the ISBT DIN number, select “no” and continue with
question 37.
Question 37: Specify the ISBT DIN number:
Report the ISBT DIN number using the letter, 12 digits, 2 sideways numbers, and the
letter in the box.
NOTE: Question 38
FormsNet3SM application: Select the appropriate registry code from the drop down
directory.
Paper form submission: Use the BMDW website to look up the registry’s appropriate
match code. Enter the match code listed in brackets.
http://www.bmdw.org/index.php?id=addresses_members&no_cache=1

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Example: Registry name: Against Leukemia Foundation Marrow Donor Registry
Match codes: Poland-ALF MDR [PL3]
Report on Pre-TED: PL3
Questions 38: Registry or UCB Bank ID:
Specify the registry used to obtain the adult donor or umbilical cord blood unit. The
Bone Marrow Donors Worldwide (BMDW) codes have been adopted to avoid submitting
the entire name and address of the donor registry.
The registry code for NMDP donors is USA1 and for NMDP cord units is U1CB.
Some common banks that do not list with BMDW have been added to the FormsNet list
for version 4, including St Louis Cord Blood Bank (SLCBB) and Viacord (VIAC).
If the donor was found through DKMS, report the registry that facilitated the HCT. Some
registries may be listed more than once with BMDW (one way for marrow/PBSC
products and differently for cord blood products). Ensure that the appropriate code for
the product was selected because distribution of data depends on the code.
If the registry code cannot be determined using the BMDW website, select “other
registry” and continue to question 39.
Question 39: Specify other Registry or UCB Bank
If the BMDW website does not list a match code for the adult donor registry or cord
blood bank, provide the registry’s official name in the “specify other registry” field.
Please ensure that the registry you are entering under “other” is not already listed in the
pull-down list for question 38. For example, NMDP adult donors, NMDP cords, and New
York Cord Bank each have their own entries above in the registry or UCB Bank ID drop
down menu.
Question 40: Specify the related donor type:
Indicate the relationship and match between the recipient and the donor.
Syngeneic:
Includes: Monozygotic (identical) twins. Occurs when a single egg is
fertilized to form one zygote, which then divides into two separate
embryos.
Does not include: Other types of twins or HLA-identical siblings (see
below).
HLA-identical sibling:
Includes: Non-monozygotic (dizygotic, fraternal, non-identical) twins.
Occurs when two eggs are fertilized by two different sperm cells at the
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same time. This category also includes siblings who aren’t twins, but have
identical HLA types.
Does not include: Half-siblings (report as “HLA matched other relatives”
if their HLA is a match, or “mismatched relative” if it does not match).
HLA-matched other relative:
Includes: All blood-related relatives, other than siblings, who are HLA
matched (e.g., parents, aunts, uncles, children, cousins, half-siblings).
Does not include: Adoptive parents/children or stepparents/children who
are HLA matched.
HLA-mismatched relative:
Includes: Siblings who are not HLA-identical and all other blood-related
relatives who have at least one HLA mismatch (e.g., parents, aunts,
uncles, children, cousins, half-siblings).
Does not include: Adoptive parents/children or stepparents/children.
Questions 41-42: Date of birth: (donor/infant)
Report if the donor’s/infant’s date of birth is “known” or “unknown.” If the donor’s/infant’s
date of birth is “known,” report the date of birth (YYYY-MM-DD) and continue with
question 45. If the donor’s/infant’s date of birth is “unknown,” continue with question 43.
Questions 43-44: Age: (donor/infant)
Report if the donor’s/infant’s age is “known” or “unknown.” If the donor’s/infant’s age is
known, report the donor’s/infant’s age at the time of product collection in question 44.
Report the age in months if the donor is less than 1 year old, otherwise report the age in
years. If the donor’s/infant’s age at collection is unknown, continue with question 45.
Question 45: Sex: (donor/infant)
Indicate the donor’s biological sex as “male” or “female.” For cord blood units, report the
infant's sex.
Questions 46-50: Specify product type:
Indicate “yes” or “no” for each product type listed for the donor specified in question 31.
Previous CIBMTR forms required you to enter two instances of the donor section when
a single donor donated multiple products. This is no longer required. Report all products
collected from a single donor in the same instance of the donor section.
Examples of “other product” type include, but are not limited to the following:
Supplemental infusion of NK Cells
Supplemental infusion of T-regulatory cells
Supplemental infusion of mesenchymal cells

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If “other product” is indicated, report the product type in “specify other product type.” If
your center has a protocol where using “other products” is common, you should be
consistently reporting the same text in the specify field so that the like products can be
grouped together.
Question 51: Specify number of products infused from this donor:
Single Product: CIBMTR defines a single product (i.e., cellular product) as cells
collected from a single donor using the same mobilization cycle and collection
method regardless of the number of collection days.
Example 1 (multiple bags): A G-CSF-stimulated donor had two PBSC
collections on subsequent days. The products collected over the two days were
divided into four bags. Although the product is contained in multiple bags, this
collection is considered a single product, as there was no change in mobilization
technique or collection method.
Multiple Products: For the purposes of this manual, the CIBMTR defines multiple
products as cells collected using more than one mobilization technique and/or
collection method.
Example 2 (multiple collection methods): A G-CSF-stimulated donor had a
PBSC collection and the product was cryopreserved. One month later the donor
had a marrow collection; both products were infused at the time of transplant.
Each collection is considered a separate product because different collection
methods were used.
Example 3 (change in mobilization): A G-CSF-stimulated donor had a PBSC
collection, but the cell count was poor. GM-CSF was administered and the donor
was re-collected. Each collection is considered a separate product due to the
change in mobilization.
Example 4 (re-mobilization): A G-CSF-stimulated donor had a PBSC collection,
but the cell count was poor. The donor was re-mobilized with G-CSF and a
second PBSC collection was performed. Each collection is considered a
separate product due to the re-mobilization of the donor.
Example 5 (two different product types): A cord blood unit is infused at the
same time as marrow. Each collection is considered a separate product.
Report the number of products infused from the donor specified in question 31.
NOTE: Questions 52-59
The following mobilization questions are for autologous HCT recipients only. If other
than autologous, continue with question 60.
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Question 52: Did the recipient have more than one mobilization event to acquire
cells for HCT?
Stem cells do not typically circulate in the bloodstream. Therefore, in order to increase
the quantity of cells for collection, an agent is frequently given to the autologous
recipient. The purpose of the agent is to move the stem cells from the bone marrow into
the peripheral blood. This practice is often referred to as mobilization or priming.
Occasionally, a bone marrow product may be primed using a growth factor.
For the purposes of this manual, the CIBMTR defines a mobilization event as the
planned administration of growth factors or systemic therapy designed to enhance stem
cell collection. If the donor requires an additional mobilization at a later date to collect an
additional product, this should be considered an additional mobilization event.
Additionally, if the mobilization methods change (e.g., plerixafor is required starting on
Day 3 of collection) this would be considered an additional mobilization event.
Example 1: An autologous recipient was mobilized with G-CSF and underwent a
two-day PBSC collection. Since the collection and mobilization methods
remained the same over the duration of the collection, this is considered one
mobilization event.
Example 2: An autologous recipient was mobilized with G-CSF and underwent a
two-day PBSC collection, but the cell count was poor. GM-CSF was administered
and the autologous recipient was re-collected. This is considered two
mobilization events due to the change in mobilization.
Example 3: An autologous recipient was mobilized with G-CSF and underwent a
one-day PBSC collection, but the cell count was poor. The recipient then
received plerixafor to enhance the mobilization. This is considered two
mobilization events due to the change in mobilization.
Question 53: Specify the total number of mobilization events performed for this
HCT (regardless of number of collections or which collections were used for this
HCT):
Report the total number of mobilization events performed. Include all mobilization
events, even if a product from the mobilization event was not used for this HCT.
Questions 54-59: Specify all agents used in the mobilization reported above:
Report if any of the following products were used in the mobilization event(s) reported in
questions 52-53. Select “yes” or “no” for each question.
G-CSF: granulocyte colony-stimulating factor, filgrastim, Neupogen®
GM-CSF: granulocyte macrophage colony-stimulating factor, sargramostim,
Leukine®
Peglygated G-CSF: pegfilgrastim, Neulasta®
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Plerixafor: Mozobil®
Other CXCR4 inhibitor: examples include POL6326 and AMD3465. Report
experimental and other CXCR4 inhibitors used to mobilize the donor here.
Combined with chemotherapy: Systemic therapies used to enhance the stem
cell product may include cyclophosphamide or ICE chemotherapy (Ifosfamide,
carboplatin, and etoposide) with or without rituximab.
Question 60: Was this donor used for any prior HCTs?
Indicate if the donor reported in question 31 was used for prior HCTs for this recipient. If
this is the recipient’s first HCT select “no.” If this is an autologous infusion, select “no.”
Question 61: Donor CMV-antibodies (IgG or Total) (Allogeneic HCTs only)
CMV is a common virus that infects 50-80% of adults worldwide, and is transmitted from
person to person through bodily fluids. The virus that causes CMV is part of the herpes
virus family and, like other herpes viruses, CMV may be dormant for a period of time
before the virus is activated in the host. CMV infections are usually harmless in a
healthy immune system and typically cause only mild symptoms, if any. However, if a
person’s immune system is seriously weakened (as in an immunosuppressed stem cell
recipient) the virus can have serious consequences such as pneumonia, liver failure,
and even death.
Most laboratory reports indicate a positive result as reactive, and a negative result as
non-reactive. Occasionally, laboratory reports show a specific antibody titer. In this
case, compare the laboratory result to the reported standards to determine if the result
was reactive or non-reactive.
If the laboratory reports a CMV IgM antibody only, not total IgG/IgM or CMV IgG
antibody; report the result as “not done.”
If the laboratory reports the results as “inconclusive” or “equivocal,” select “not done.”
If the laboratory reports CMV testing by PCR (DNA detection), report the result as “not
done.” CMV testing by PCR is used to detect the presence of the CMV virus and does
not test for prior exposure.
Indicate the test result documented on the laboratory report as either “reactive,” “nonreactive,” “not done,” or “not applicable (cord blood unit).”
Question 62: Was plerixafor (Mozobil) given at any time prior to the preparative
regimen? (Related HCTs only)
Stem cells do not typically circulate in the bloodstream. Therefore, in order to increase
the quantity of cells for collection, an agent is frequently given to the allogeneic donor or
autologous recipient. The purpose of the agent is to move the stem cells from the bone
marrow into the peripheral blood. This practice is often referred to as mobilization or
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priming. Indicate if the donor received plerixafor at any time prior to the preparative
regimen.

Consent
To be compliant with Federal Regulations for human research subject protection,
centers must obtain IRB-approved informed consent from recipients and donors to allow
data submitted to the CIBMTR to be used for observational research. Informed consent
must also be obtained from recipients and donors prior to submitting blood samples to
the Research Sample Repository. The NMDP/CIMBTR has written protocols and
informed consent documents for the Observational Database and Research Sample
Repository. All centers must have local IRB approval for the Observational Database
protocol. All centers that are NMDP member centers must also have local IRB approval
for the Research Sample Repository protocol. With the exception of some selected sites
(participating in the related sample repository), centers performing only related donor
transplants and/or autologous transplants will not be submitting research samples and
do not need to obtain local IRB approval for the repository protocol. The NMDP IRB has
approved these protocols and consent forms, and the documents are provided to
participating sites to include with their local IRB submissions.
International Centers must obtain consent of each patient participating in the
Observational Database in a manner consistent with the laws and regulations of that
country.
Under federal legislation, U.S. centers are required to submit outcomes data on all
allogeneic transplants, related and unrelated. Data submitted without informed consent
from the recipient should be reported on the TED Forms and will only be used for
federally required research such as the center-specific outcomes analysis.
Question 63: Has the recipient signed an IRB-approved consent form for
submitting research data to the NMDP/CIBMTR?
When a recipient consents to participate in the Observational Database, their data are
contained in the CIBMTR’s Observational Database and used for research. The
database includes recipient baseline and outcome data for related and unrelated
allogeneic transplants from any cell source, and for autologous transplants. Data are
also collected on unrelated donors and their donation experiences.
The primary purpose of the Observational Database is to have a comprehensive source
of data that can be used to study hematopoietic cellular transplantation. Studies using
these data include:
How well recipients recover from their transplants.
How recovery after transplantation can be improved.
What the long-term outcomes are after transplantation.
How access to transplantation for different groups of recipients can be improved.
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How well donors recover from collection procedures.
The application and success of transplantation in the management of marrowtoxic injuries.
Indicate if the recipient has signed an IRB-approved consent form to participate in the
Observational Database. If “yes (patient consented),” continue with question 64. If “no
(patient declined)” or “not applicable (patient not approached),” continue with question
65.
Question 64: Date form was signed:
Report the date the research database consent form was signed by the recipient. Do
not report the date that the witness or health care professional signed the consent form.
Question 65: Did the recipient give permission to be directly contacted for future
research?
Indicate if the recipient has given permission to be directly contact by the
NMDP/CIBMTR for future research as documented on the research database consent
form. If “yes (patient provided permission),” continue with question 66. If “no (patient
declined)” or “not approached,” continue with question 67.
Below is an example of this permission found in the NMDP/CIBMTR Research
Database for Hematopoietic Cell Transplantation and Cellular Therapy Consent Form
(Version 10.0).
VIII. PERMISSION TO CONTACT FOR FUTURE CIBMTR RESEARCH STUDIES
Do you agree to give the CIBMTR permission to contact you in the future to tell you
about research studies for which you are eligible? These studies are different from the
studies that use your medical data. These studies would involve you directly, for
example, asking you to complete a survey. You may decide if you want to participate in
a specific study when you are contacted. By checking the “AGREE” box below, you are
only agreeing that the CIBMTR can contact you to tell you about the study.
Due to the need to follow up with you after your transplant, please tell your transplant
center if your contact information changes. If the contact information on file is no longer
valid, it might be necessary to use an internet-based search service to find you. By
agreeing to be contacted for future studies, you authorize the CIBMTR to use such a
service to search public and non-public information only for the purpose of trying to
locate you.
☐
☐

I AGREE to allow CIBMTR to contact me about future studies.
I DO NOT want CIBMTR to contact me about future studies.

If the recipient declined to take part in the CIBMTR Research Database (as indicated in
question 63) but gave permission to be contacted for future CIBMTR studies, ensure
that there is documentation before selecting “yes.”
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Question 66: Date form was signed:
Report the date the research database consent form was signed by the recipient. Do
not report the date that the witness or health care professional signed the consent form.
Question 67: Has the recipient signed an IRB-approved consent form for
submitting research blood samples to the NMDP/CIBMTR?
The Research Sample Repository contains blood samples from unrelated recipients
and/or their adult volunteer donors or cord blood units. Related allogeneic recipients
and/or donors will participate at selected transplant centers.
The primary objective of the Research Repository is to make blood samples available
for research studies related to histocompatibility and hematopoietic cellular
transplantation.
Studies in which these data may be used include:
Improving the understanding of tissue matching for hematopoietic cellular
donors and recipients.
Determining and evaluating the factors that affect transplant outcomes.
Studying the distribution of HLA tissue types in different populations (e.g., study
tissue typing differences between different racial and ethnic populations to help
develop methods to improve tissue matching between donors and recipients,
including testing of rare HLA types).
Indicate if the recipient signed an IRB-approved consent form to donate research blood
samples to the NMDP/CIBMTR. If “yes (patient consented),” continue with question 68.
If “no (patient declined),” “not approached,” or “not applicable (center not participating),”
continue with question 69.
Question 68: Date form was signed:
Report the date the research sample consent form was signed by the recipient. Do not
report the date that the witness or health care professional signed the consent form.
Question 69: Has the donor signed an IRB-approved consent form for submitting
research blood samples to the NMDP/CIBMTR? (Related donors only)
Indicate if the donor signed an IRB-approved consent form to donate research blood
samples to the CIBMTR. If “yes (donor consented),” continue with question 70. If “no
(donor declined),” “not approached,” or “not applicable (center not participating),”
continue with question 71.
Question 70: Date form was signed:
Report the date the research sample consent form was signed by the donor. Do not
report the date that the witness or health care professional signed the consent form.

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Product Processing/Manipulation
Question 71: Was the product manipulated prior to infusion?
If any part of the product was manipulated in any way prior to infusion, select “yes.” Do
not report cryopreservation as a method of manipulation.
If the product was not manipulated, select “no” and continue with question 90.
Question 72: Specify portion manipulated:
Indicate the portion of the product that was manipulated. If the entire product was
manipulated, select “entire product” and continue with question 73. If a portion of the
product was removed and manipulated, select “portion of product” and continue with
question 73.
If different portions of the product were manipulated in different ways, select “portion of
product” to indicate that the manipulation were not performed on the entire product.
Questions 73-89: Specify all methods used to manipulate the product:
Indicate the method(s) of stem cell manipulation. Answer each question as “yes” or “no”
and do not leave any questions blank.
Washed: Washing is performed to remove cryoprotectant (such as
DMSO) from the product.
Diluted: Dilution is performed to reduce the cell concentration.1
Buffy coat enriched: Buffy coat enrichment is performed to
reduce/remove mature erythrocytes and plasma.1
B-cell reduced: B cell reduction is performed to reduce/remove the
quantity of B cells in the product.1
CD8 reduced: CD8 reduction is performed to reduce/remove the
population of CD8 cells in the product.1 The removal of CD8 cells may
mitigate the risk of GVHD.
Plasma reduced (removal): Plasma reduction is performed to remove
plasma via sedimentation or centrifugation.1
RBC reduced: RBC reduction is performed to reduce/remove mature
erythrocytes from the product.1
Cultured (ex-vivo expansion): Ex-vivo expansion is a method of
culturing cells to “activate, expand, or promote development of a specified
cell population in the presence of specific additive(s).”1
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Genetic manipulation (gene transfer/transduction): Gene manipulation
refers to any method used to modify the genes in the product cells. Gene
transduction refers to the transfer of genes from one cell to another.
Genetic manipulation is still in the early investigative phase of research.
PUVA treated: Product treated with psoralen and ultraviolet light (PUVA).1
CD34 enriched (CD34+ selection): CD34+ selection is a manipulation
method also known as “positive selection.” This method identifies and
selects stem cells that have a CD34+ marker on the cell surface.
CD133 enriched: CD133 enrichment identifies and selects stem cells that
have a CD133 marker on the cell surface.
Monocyte enriched: Monocyte enrichment identifies and selects
monocytes.
Mononuclear cells enriched: Mononuclear cell enrichment identifies and
selects mononuclear cells.
T-cell depletion: T-cell depletion removes some or all of the T-cells in an
effort to minimize GVHD. Methods of T-cell depletion include antibody
affinity column, antibody-coated plates, antibody-coated plates and
soybean lectin, antibody + toxin, immunomagnetic beads, and CD34
affinity column plus sheep red blood cell resetting.
If a method of manipulation was performed on the product, but is not listed
above, select “yes” for question 88 and specify using question 89. Do not report
cryopreservation (or processing used in the cryopreservation process) as
manipulation.
1

ISTB 128. Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. ICCBBA ST-002. Version. 4.27.
September 2013. Accessed at: http://www.iccbba.org/uploads/96/60/9660f990fd21673374216d937feff66f/Standard-Terminology-forBlood-Cellular-Therapy-and-Tissue-Product-Descriptions-v4.27.pdf Accessibility verified on October 21, 2013

Clinical Status of Recipient Prior to the Preparative Regimen
(Conditioning)
Question 90: What scale was used to determine the recipient’s functional status?
The CIBMTR uses the Karnofsky/Lansky scale to determine the functional status of the
recipient immediately prior to the start of the preparative regimen. The Karnofsky Scale
is designed for recipients aged 16 years and older, and is not appropriate for children
under the age of 16. The Lansky Scale is designed for recipients less than 16 years old.

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Questions 91-92: Performance score prior to the preparative regimen:
Recipient performance status is a critical data field that has been determined to be
essential for all outcome-based studies. The CIBMTR uses the Karnofsky/Lansky scale
to determine the functional status of the recipient immediately prior to the start of the
preparative regimen. For the purposes of this manual, the term “immediately prior”
represents the pre-HCT work-up phase, or approximately one month prior to the
start of the preparative regimen. In cases where the pre-transplant work-up occurs in
months prior to transplant (i.e., the pre-transplant workup occurs more than one month
prior to transplant), a documented performance score may be submitted if the recipient
does not have a score closer to the start of the preparative regimen, the recipient
receives no additional treatment after the date of assessment, and the recipient’s status
does not clearly decline.
Select the appropriate performance scale, Karnofsky or Lansky, based on the
recipient’s age. Using this scale, select the score (10-100) that best represents the
recipient’s activity status immediately prior to the start of the preparative regimen. For
an example of the Karnofsky/Lansky scale, see Appendix L.
If a Karnofsky/Lansky score is not documented in the source documentation (e.g.,
inpatient progress note, physician’s clinic note), data management professionals
should not assign a performance score based on analysis of available documents.
Rather, a physician should provide documentation of the performance score.
The CIBMTR recognizes that some transplant centers prefer to collect and use the
ECOG performance score as opposed to the Karnofsky/Lansky score. Although the
ECOG and Karnofsky/Lansky performance score systems are based on similar
principles, the scales are not the same. For example, the Karnofsky/Lansky scale is
described in 11 categories, whereas the ECOG performance status is reported in six
categories. Due to the overlap between the two systems, an ECOG score of “one” can
represent either “80” or “90” on the Karnofsky/Lansky scale. For centers that collect only
an ECOG performance score, CIBMTR will make the following accommodations when
auditing the source data:
Centers collecting ECOG scores should do so using standard practices to
ensure accuracy.
For the purposes of CIBMTR reporting, conversion of ECOG to
Karnofsky/Lansky should follow a standard and consistent practice. This
practice should be clear and reproducible.
For more information regarding converting an EGOG score to a Karnofsky/Lansky
score, see Appendix L.
Question 93: Recipient CMV-antibodies (IgG or Total):
Report the cytomegalovirus (CMV) status of the recipient immediately prior to the start
of the preparative regimen. For the purposes of this manual, the term “immediately
prior” represents the pre-HCT work-up phase, or approximately one month prior to
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the start of the preparative regimen. An exception to this definition would apply to a
recipient with a documented history of a “reactive” CMV test result. In this case, the
CMV test may not be repeated during the pre-HCT work-up phase. Therefore a
timeframe of greater than one month prior to the start of the preparative regimen is
acceptable. In cases where the pre-transplant work-up occurs in months prior to
transplant (i.e., the pre-transplant workup occurs more than one month prior to
transplant), a CMV assessment may be submitted if the recipient does not have an
assessment closer to the start of the preparative regimen.
CMV is a common virus that infects 50-80% of adults worldwide, and is transmitted from
person to person through bodily fluids. The virus that causes CMV is part of the herpes
virus family and, like other herpes viruses, CMV may be dormant for a period of time
before the virus is activated in the host. CMV infections are usually harmless in a
healthy immune system and typically cause only mild symptoms, if any. However, if a
person’s immune system is seriously weakened (as in an immunosuppressed stem cell
recipient) the virus can have serious consequences such as pneumonia, liver failure,
and even death.
Most laboratory reports indicate a positive result as reactive, and a negative result as
non-reactive. Occasionally, laboratory reports show a specific antibody titer. In this
case, compare the laboratory result to the reported standards to determine if the result
was reactive or non-reactive.
If the laboratory reports a CMV IgM antibody only, not total IgG/IgM or CMV IgG
antibody; report the result as “not done.”
If the laboratory reports the results as “inconclusive” or “equivocal,” select “not done.”
Recipients < 6 months: If the recipient is less than 6 months old, report any
positive CMV antibody results as “inconclusive” due to the presence of maternal
antibodies. However, in infants less than 6 months old, positive CMV PCR results
indicate a CMV infection and the results may be reported as “reactive.”
Exposure to IVIG: Exposure to IVIG may result in a false positive CMV antibody
result. If the recipient has been exposed to IVIG leading up to HCT (within 3-6
months), indicate the CMV antibody results using the following guidelines:
If the recipient had a non-reactive CMV antibody result prior to IVIG therapy
and then routine CMV PCR results showed no copies of CMV, the CMV
antibody may be reported as “non-reactive,” even if the CMV antibody
became reactive during IVIG treatment.
If CMV PCR results quantified copies of CMV DNA (i.e., was positive) during
IVIG treatment, the results may be reported as “reactive.”
If the recipient did not have a CMV antibody test prior to the initiation of IVIG,
but had a positive antibody test during the IVIG therapy, report “not done.”
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“Not done” should be reported if no CMV antibody tests were done prior to the
initiation of IVIG therapy, even if CMV PCR testing was negative during IVIG
treatment (because CMV PCR only detects active infection, not prior
exposure).
For other situations, if the laboratory reports CMV testing by PCR (DNA
detection) but no CMV antibody testing is done during the pre-transplant work-up
or within one month prior to transplant, report the result as “not done.” CMV
testing by PCR is used to detect the presence of the CMV virus and does not test
for prior exposure.
Indicate the test result documented on the laboratory report as either “reactive,” “nonreactive,” or “not done.”

Comorbid Conditions
Question 94: Is there a history of mechanical ventilation?
A history of mechanical ventilation may impact the recipient’s pulmonary function postHCT. Mechanical ventilation is any assisted ventilation on behalf of the recipient.
Mechanical ventilation can occur as both an endotracheal tube and ventilator, or as a
BIPAP machine with a tight fitting mask in continuous use. The one exception to BIPAP
is CPAP used for sleep apnea, which generally involves overnight use only for patients
with documented sleep apnea. Therefore, do not report a CPAP used for sleep apnea,
as it does not have the same implications as other forms of mechanical ventilation.
Indications for mechanical ventilation include, but are not limited to:
Apnea with respiratory arrest (excludes sleep apnea)
Acute lung injury
Vital capacity < 15 mL/kg
Chronic obstructive pulmonary disease (COPD)
Clinical deterioration
Respiratory muscle fatigue
Obtundation or coma
Hypotension
Tachypnea or bradypnea
If the recipient was placed on mechanical ventilation at any time prior to this HCT event
(excluding mechanical ventilation during surgery) check “yes.” If the recipient does not
have a history of mechanical ventilation, check “no.”
Question 95: Is there a history of proven invasive fungal infection?
Fungal infections play a major role in the clinical outcome of transplant recipients. For
the purposes of this manual, the term “proven” is defined as a pathologic specimen or
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culture that yields a positive result. For example, a chest x-ray that reveals a nodule is
not considered a “proven” diagnosis of aspergillus. A biopsy of a specimen with a
positive culture for aspergillus is a proven diagnosis.
If the recipient has a history of proven invasive fungal infection at any time prior to this
HCT, check “yes.” If the recipient has not had a history of a proven invasive fungal
infection, check “no.” For a subsequent HCT, report any documented significant fungal
infections in the recipient’s medical history, starting with the preparative regimen of the
previous HCT to the time prior to the preparative regimen for the current HCT.
Examples of proven invasive fungal infections include, but are not limited to: invasive
aspergillosis, zygomycosis and other molds, invasive candidiasis, cryptococcosis,
endemic mycosis, other yeasts, and pneumocystosis.
Non-invasive fungal infections such as thrush and nail fungus should not be reported.
For assistance with reporting fungal infections, consult a transplant physician.
NOTE: Questions 96-133
Prior to answering question 96, review the list of co-existing disease(s) and/or organ
impairments listed under questions 97-133.
Question 96: Were there clinically significant co-existing disease or organ
impairment at the time of patient assessment prior to preparative regimen?
Report “yes” to question 96 if the recipient has a documented history and/or current
diagnosis of any of the following:
Documented Medical History
Arrhythmia
a
Cardiac
Cerebrovascular disease
b
Heart valve disease
Inflammatory bowel disease
Peptic ulcer
Rheumatologic
c
Solid tumor, prior
Current diagnosis at the time of pre-HCT evaluation
Diabetes
d
Hepatic, mild
Hepatic, moderate/severe
Infection
Obesity
(cont. on next page)

Question Number
97
98
99
101
105
107
112
113
Question Number
100
102
103
104
106

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Current diagnosis at the time of pre-HCT evaluation
(cont.)
Psychiatric disturbance
Pulmonary, moderate
Pulmonary, severe
e
Renal, moderate/severe
Other (specify)

Question Number
108
109
110
111
132 (133)

a

Ejection fraction (EF) ≤ 50% should be reported only if present on most recent test
Excluding asymptomatic mitral valve prolapse
Excluding non-melanoma skin cancer, leukemia, lymphoma, or multiple myeloma
d
Including any history of hepatitis B or hepatitis C infection
e
Including renal transplantation at any time in the patient’s history
b
c

The intent of this question is to identify serious pre-existing conditions that may have an
effect on the outcome of the HCT. For the purposes of this manual, the term “clinically
significant” refers to conditions that are being treated at the time of pre-HCT evaluation,
or are in the recipient’s medical history and could cause complications post-HCT.
Conditions listed in the recipient’s medical history that have been resolved (e.g.,
appendectomy), and/or that would not pose a concern during or after the HCT should
not be reported.
Additionally, for the purposes of this manual, the term “at the time of patient
assessment” is defined as the pre-HCT evaluation period prior to the start of the
preparative regimen. If the recipient does not have a documented history of clinically
significant disease(s) or organ impairment(s), check “no” and continue with question
134.
For information regarding reporting clinically significant co-existing disease or organ
impairment, see Appendix U.
Questions 97-133: Co-existing diseases or organ impairments
For each listed co-existing disease or organ impairment, check “yes,” “no,” or
“unknown.”
Arrhythmia: Any history of atrial fibrillation or flutter, sick sinus syndrome, or
ventricular arrhythmias requiring treatment.
Cardiac: Any history of coronary artery disease (one or more vessel coronary
artery stenosis requiring medical treatment, stent, or bypass graft), congestive
heart failure, myocardial infarction, or ejection fraction < 50% on the most recent
test.
Cerebrovascular disease: Any history of transient ischemic attack,
subarachnoid hemorrhage, or cerebrovascular accident.
Diabetes: Requiring treatment with insulin or oral hypoglycemics in the last 4
weeks but not diet alone
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Heart valve disease: Except asymptomatic mitral prolapse.
Hepatic (mild): Chronic hepatitis, bilirubin > upper limit of normal to 1.5x upper
limit of normal, or AST/ALT > upper limit of normal to 2.5x upper limit of normal at
the time of transplant, or any history of hepatitis B or hepatitis C infection.
Hepatic (moderate/severe): Liver cirrhosis, bilirubin > 1.5x upper limit of normal,
or AST/ALT > 2.5x upper limit of normal.
Infection: Documented infection, fever of unknown origin, or pulmonary nodules
requiring continuation of antimicrobial treatment after day 0.
Inflammatory bowel disease: Any history of Crohn’s disease or ulcerative colitis
requiring treatment.
Obesity: Patients with a body mass index > 35 kg/m2 at time of transplant.
Peptic ulcer: Any history of peptic ulcer confirmed by endoscopy and requiring
treatment.
Psychiatric disturbance: Depression, anxiety, bipolar disorder, or
schizophrenia requiring psychiatric consult or treatment in the last 4 weeks.
Pulmonary (moderate): Corrected diffusion capacity of carbon monoxide (e.g.,
DLCOc, DLCOcorr, DLCO(Hb)) and/or FEV1 66-80% or dyspnea on slight activity
at transplant.
Pulmonary (severe): Corrected diffusion capacity of carbon monoxide (e.g.,
DLCOc, DLCOcorr, DLCO(Hb)) and/or FEV1 ≤ 65% or dyspnea at rest or
requiring oxygen at transplant.
Renal (moderate/severe): Serum creatinine > 2 mg/dL or > 177 μmol/L, or on
dialysis at transplant, or prior renal transplantation.
Rheumatologic: Any history of systemic lupus erythematosus, rheumatoid
arthritis, polymyositis, mixed connective tissue disease, or polymyalgia
rheumatica requiring treatment (do NOT include degenerative joint disease,
osteoarthritis)
Solid tumor (prior): Treated at any time point in the patient’s past history,
excluding non-melanoma skin cancer, leukemia, lymphoma, or multiple
myeloma. For each listed prior solid tumor, check “yes” or “no.” If “yes,” enter the
year of diagnosis of the corresponding solid tumor.
Other co-morbid condition: The “other, specify” category should be used to
report co-morbid conditions that are of similar clinical concern as the other listed
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options. Chromosomal abnormalities, impairments and/or disorders associated
with the primary disease should not be reported in this section, (e.g., Ph+ for
CML/ALL recipients).
The physician performing the recipient’s pre-HCT evaluation may use the HCT CoMorbidity Index (HCT-CI) to document co-morbid conditions (see Appendix M).
Question 134: Was there a history of malignancy (hematologic or non-melanoma
skin cancer) other than the primary disease for which this HCT is being
performed?
The intent of this question is to identify other malignancies that may have an effect on
the outcome of the HCT. A history of any benign tumor(s) should not be reported in this
section. Malignancies reported in the previous solid tumor options should not be
reported again here.
If the recipient is transplanted for a disease that has transformed from one disease to
another, the original malignancy should not be reported in this section. Report the
original malignancy as part of the appropriate disease subtype description in the
Primary Disease for HCT section (questions 356-645). For more information regarding
disease combinations and transformations, refer to Table 1 and Table 2.
Indicate if there was a history of malignancy other than the disease for which this HCT
is being performed.
Question 135-154: Specify which malignancy(ies) occurred:
For each listed prior malignancy, check “yes” or “no.” If “yes,” enter the year of
diagnosis of the corresponding malignancy.
Use questions 152-154 to report any prior malignancies that were not listed in questions
135-150.

Pre-HCT Preparative Regimen (Conditioning)
Question 155: Height at initiation of pre-HCT preparative regimen:
Report the recipient’s height just prior to the start of the preparative regimen. The intent
of this question is to determine the height used when calculating preparative regimen
drug doses. This height is usually documented on the transplant orders (for radiation
and/or systemic therapy) or admitting orders. Report height to the nearest whole
centimeter or inch (round up if 0.5 or greater).
Question 156: Actual weight at initiation of pre-HCT preparative regimen:
Report the recipient’s actual body weight just prior to the start of the preparative
regimen. The intent of this question is to determine the weight used when calculating
preparative regimen drug doses. This weight is usually documented on the transplant
orders (for radiation and/or systemic therapy) or admitting orders. Report weight to the
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nearest whole kilogram or pound (round up if 0.5 or greater). Do not report adjusted
body weight, lean body weight, or ideal body weight.
Question 157: Was a pre-HCT preparative regimen prescribed?
Recipients are generally transplanted under a specific protocol that defines the radiation
and/or systemic therapy the recipient is intended to receive as a preparative regimen.
This protocol, which may be either a research protocol or standard of care protocol,
should be referred to when completing this section.
However, there are instances when a preparative regimen is not be given. Examples
may include, but are not limited to:
Primary diagnosis of an immune deficiency.
Subsequent allogeneic HCT due to loss of, or poor, neutrophil engraftment.
If a preparative regimen is prescribed per protocol, check “yes” and continue with
question 156. If a preparative regimen is not prescribed, check “no” and continue with
question 316.
For more information regarding the recipient’s preparative regimen, consult a transplant
physician or contact your center’s CIBMTR CRC.
Question 158: Classify the recipient’s prescribed preparative regimen:
Myeloablative pre-transplant conditioning destroys bone marrow cells using high-dose
radiation and/or systemic therapy. It is used to eliminate the recipient’s immune system
and to leave space in the bone marrow niche for the donated cells. A myeloablative
regimen is sometimes used for recipients with non-malignant diseases who require HCT
for marrow reconstitution (i.e., immunodeficiencies) or to produce a complete donor
chimerism.
Non-myeloablative stem cell transplant (NMA or NST) and reduced-intensity
conditioning (RIC) preparative regimens generally use lower doses of radiation and/or
systemic therapy to prevent graft rejection and to suppress the recipient’s hematopoietic
immune system, but not eliminate it completely. Non-myeloablative protocols rely on the
immune cells of the donor to destroy the disease (called graft versus tumor or GVT
effect), and typically produces mixed chimerism. NST is a common treatment option for
recipients who are older or who have other health problems, as the lower radiation
and/or systemic therapy doses are easier for the recipient to tolerate.
In general, RIC includes any regimen that does not meet the criteria for either
myeloablative or non-myeloablative regimens.

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The determination of whether the intent of the regimen was myeloablative, NST, or RIC
should be based either on the protocol at your center or the opinion of the physician
overseeing the care of the recipient at your center.
Indicate whether the intent of the preparative regimen was “myeloablative” (to produce
marrow ablation or pancytopenia), “non-myeloablative,” or “reduced intensity.”
Question 159: Date pre-HCT preparative regimen began (irradiation or drugs):
Enter the date the preparative regimen began. Use the earliest date from questions
161-167 (radiation) or questions 168-315 (chemotherapy). All dates reported in the
preparative regimen section must be equal to or after the date reported for this question.
Question 160: Was irradiation planned as part of the pre-HCT preparative
regimen?
If irradiation is planned as part of the preparative regimen, check “yes” and continue
with question 161. If irradiation is not planned, check “no” and continue with question
168. Irradiation performed as previous treatment should not be reported in this section.
Report irradiation performed as previous treatment on the appropriate Disease Specific
Form.
Question 161: What was the prescribed radiation field?
Indicate if the planned irradiation was to “total body,” “total body by tomotherapy,” “total
lymphoid or nodal regions,” or “thoracoabdominal region.”
Question 162: Total prescribed dose:
Enter the total dose of radiation prescribed. If radiation was prescribed as a single dose,
the amount of radiation delivered in the single dose constitutes the total dose. If the
radiation was prescribed in fractionated doses, multiply the dose per fraction by the total
number of fractions to determine the total dose. Enter the total dose of radiation in either
grays (Gy) or centigrays (cGy).
Example:
Radiation Order: TBI, 200 cGy/day for three days (3 doses)
Total dose: 200 cGy x 3 doses = 600 cGy
Report “Total Dose” as: 600 cGy

Question 163: Date started:
Enter the date the single dose or first fraction of radiation was administered.
Question 164: Was the radiation fractionated?
Radiation is either delivered as a single dose or in several treatments (fractions).
Radiation is fractionated to increase the loss of diseased cells, as they do not recover
as quickly as disease-free cells.
If the radiation was fractionated, check “yes” and continue with question 165. If the
radiation was not fractionated, check “no” and continue with question 168.
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Question 165: Prescribed dose per fraction:
Enter the prescribed dose per fraction in either grays (Gy) or centigrays (cGy).
The dose per fraction multiplied by the total number of fractions (question 167) must be
equal to the total dose reported in question 162.
Question 166: Number of days:
Enter the total number of days radiation therapy was prescribed, including any days of
rest between days when therapy was administered. The number of days radiation was
administered can be greater than the number of fractions.
Example:
Radiation Order: TBI, 200 cGy/day every other day (Mon-Wed-Fri) x 3 doses
Total dose: 200 cGy x 3 doses = 600 cGy
Report “Number of days” as: 5

Question 167: Total number of fractions:
Enter the total number of fractions (treatments) of radiation that were administered. The
recipient may receive more than one fraction per day (hyperfractionation).
The total number of fractions multiplied by the dose per fraction (question 165) must be
equal to the total dose reported in question 162.
NOTE: Preparative Regimen - Drugs
The following questions report the prescribed drug therapy that was part of the
preparative regimen. Do not report the dose that was actually given. If the recipient has
comprehensive report forms due, the actual dose given will be reported on the Recipient
Baseline Form (Form 2000). Do not include drugs that are intended to offset the
side effects of the chemotherapy (e.g., corticosteroids for nausea, MESNA for
hemorrhagic cystitis, etc.).
ATG and alemtuzumab (Campath) given for GVHD prophylaxis planned prior to Day 0
should be reported in the preparative regimen section of the Pre-TED. If ATG and
alemtuzumab are planned after Day 0, it should be reported in the GVHD prophylaxis
section (questions 316-341).
The form lists each drug by the generic name. The form also lists some drugs by broad
categories, with specific drugs listed individually. For example, anthracycline is listed as
the broad drug category, followed by the specific drugs daunorubicin, doxorubicin, and
idarubicin. The following website provides the trade names under which generic drugs
are manufactured: http://www.rxlist.com/script/main/hp.asp.
Questions 168-315: Drugs
Report the total dose of each drug as prescribed in the preparative regimen section of
the HCT protocol. Do not report the prescribed daily dose. Drug doses must be
reported in whole numbers. If the total dose includes a decimal, round to the nearest
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whole number. For paper submission, do not modify the number of boxes or include
decimal values. The pharmacy record or Medication Administration Record (MAR)
should be used for determining the date the drug was started.
Report the dose units as either “mg/m2,” “mg/kg,” “target total AUC (µmol x min/L),”
“mCi,” or “MBq.” If the total prescribed dose is reported in a unit other than those listed,
convert the dose to the appropriate unit. See the example below or consult with a
transplant pharmacist for the appropriate conversion. If drug doses cannot be converted
to the unit listed (e.g., Campath), leave the unit field blank, override the error (using
“unable to answer”), and attach a copy of the source document to the Pre-TED using
the Log of Appended Documents (Form 2800).
Example: Calculating Total Drug Doses
Drug doses are calculated either by recipient weight in kilograms (kg) or recipient body
surface area (BSA) in m2. The HCT protocol will specify “x mg/kg” or “x mg/m2” and the
total number of doses to be administered.
For example, if the protocol requires cyclophosphamide at 60 mg/kg x 2 days (i.e., 2
doses), the “total prescribed dose” should be reported as “120 mg/kg.”
Pharmacokinetic testing can be used to determine whether the drug concentration in the
bloodstream is appropriate to the dose given. This reflects the speed of absorption and
elimination of the drug. These tests are usually performed using the first dose of
systemic therapy, or a test dose, where multiple samples are drawn at specific time
points following the first dose. The samples are sent to a laboratory that performs the
testing to determine the drug concentration. If carboplatin was prescribed, indicate if
pharmacokinetic testing was performed to determine the preparative regimen dosing. If
it is not known whether or not this testing was performed, consult a transplant physician.
A common example of this situation occurs in the use of busulfan. In some cases, a
“test dose” of the drug is given before the actual preparative regimen is started, and this
dose is used for acquiring drug levels that are used to adjust the dose that will be used
in the preparative regimen. In other situations, the first dose of the drug is given in the
usual fashion as part of the preparative regimen. After this first dose, serum drug levels
are drawn and sent to a reference lab. The drug is continued at the starting dose until
the lab results are reported and adjustment is made to later doses.
When a drug is used for the preparative regimen where pharmacokinetics will be tested,
it is important to distinguish whether the testing will be done with a “test dose” before
beginning the preparative regimen or using the first dose of the preparative regimen.
The reporting of the dosing for the CIBMTR forms depends upon this distinction. This
helps distinguish whether the dose is part of the therapeutic regimen, or not.

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1. A test dose was given > 24 hours prior to the intended therapeutic dosing.
 Example: A patient with AML underwent allogeneic HCT from a sibling;
busulfan and cyclophosphamide were used as the preparative regimen.
The patient presented to clinic 9 days before the HCT, where a dose of
busulfan at 0.5 mg/kg was given intravenously. Blood samples were
drawn for the next 6 hours, after which the patient left the clinic. His
samples were sent to a lab, results were returned the next day, and an
adjusted dose of busulfan was calculated. He returned to the hospital 6
days before HCT, and began to receive busulfan at the adjusted dose
intravenously for 4 days, followed by cyclophosphamide, and proceeded
to receive his cells. Since he received 0.5 mg/kg as a “test dose,” this
would not be reported in his total preparative regimen dose.
If a test dose was given, where the dose was distinct from the therapeutic
dosing preparative regimen (often 1-2 or more days prior to the initiation of
regular dosing), the following should be reported:
a. On the Pre-TED (2400) form, the total prescribed dose per protocol
would NOT include the test dose.
b. On the Baseline (2000) form, the start date of the chemotherapy
agent should be reported as the date the first therapeutic dose was
administered. The actual dose received would NOT include the test
dose.
2. The first dose of therapeutic dosing is used for monitoring.
 Example: A patient with MDS received an allogeneic HCT from an
unrelated donor; busulfan and fludarabine were used as the preparative
regimen. She was admitted to the hospital 7 days before her HCT, and
received a dose of busulfan at 0.8 mg/kg IV at 6:00 AM. Serum samples
were drawn every 30 minutes until the next dose of Busulfan at 0.8 mg/kg
IV was given at 12:00 noon. Her blood was sent to a reference lab, and
she continued to receive busulfan every 6 hours. On day -6, the lab called
with her drug levels, and it was determined that the current dose was
correct. No adjustment was made, and she completed all 16 doses of
busulfan. Since the dose of busulfan (0.8 mg/kg) that was used for drug
testing was ALSO her first dose of the preparative regimen, it should be
included in the amount of drug that was given for preparative regimen.
The total prescribed dose per protocol should be reported as “13 mg/kg.”
(0.8 mg/kg x 16 doses = 12.8 mg/kg rounded to 13 mg/kg).
If the first dose of the preparative regimen was used to determine
pharmacokinetics, the following should be reported:
a. On the Pre-TED (2400) form, the total prescribed dose per protocol
would include the dose used for monitoring.
b. On the Baseline (2000) form, the start date of the chemotherapy
agent should be reported as the date the first dose was
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administered. The actual dose received would include the dose
used for monitoring.
Test doses must be reported consistently at your center. Since most centers follow a
consistent approach to pharmacokinetic testing, it should be straightforward for the
center to adopt a consistent approach to the reporting of test doses.
The “other, specify” category should be used only if the drug is not one of the listed
options. If more than one “other” drug is prescribed, list the name of the drugs in the
space provided and attach a copy of the source document to the Pre-TED using the
Log of Appended Documents (Form 2800).Do not report additional sites of radiation
(e.g., cranial boost) in the “other” drug category. If the recipient is assigned to the
Comprehensive Report Forms by the form selection algorithm, the additional sites of
radiation will be reported on the Recipient Baseline Form (Form 2000). If the recipient is
assigned to TED Forms by the form selection algorithm, the additional sites of radiation
will not be reported.
If the Pre-TED is being completed for a subsequent HCT, do not report therapy that was
given to treat the recipient’s disease (between the previous and current planned HCTs)
in the preparative regimen section.
If there is a change to the chemotherapy preparative regimen (e.g., from busulfan +
fludarabine to melphalan + fludarabine) after the Form 2400 has been submitted, an
error correction must be completed in FormsNet to update the chemotherapy regimen
given.

GVHD Prophylaxis
NOTE: Questions 316-341
The following GVHD prophylaxis questions are to be completed for allogeneic HCTs
only. Autologous and syngeneic HCTs continue with question 342.
If it was planned that ATG and Campath were to be given for GVHD prophylaxis prior to
Day 0, this should be reported in the preparative regimen section of the Pre-TED
(questions 168-315). If it was planned that ATG and Campath were to be given after
Day 0, this should be reported in the GVHD prophylaxis section (questions 316-341).
Question 316: Was GVHD prophylaxis planned/given?
After allogeneic HCT, specific immunosuppressive therapy may be administered to
prevent GVHD or to immunosuppress the host marrow, thereby promoting engraftment
of the donor stem cells. Most transplant centers have specific GVHD prophylaxis
protocols and graft rejection protocols. Planned agents a recipient received as a result
of these protocols should be included in this section.

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If GVHD prophylaxis was planned per protocol, check “yes” and continue with question
317. If GVHD prophylaxis was not planned per protocol, check “no” and continue with
question 342.
Questions 317-341: Specify:
The prophylactic drug options listed on the form are intended to be administered in a
systemic or oral form. If the recipient received one of the listed drugs in a topical form,
report the drug in the “other, specify” category.
Do not report T-cell depletion of the product or drugs administered after the onset of
GVHD.
The Pre-TED Form lists the generic chemotherapy drug names. The following website
provides the trade names under which generic drugs are manufactured:
http://www.rxlist.com/script/main/hp.asp
If GVHD prophylaxis is used for a syngeneic (monozygotic or identical twin) or
autologous HCT, attach a copy of the source document to the Pre-TED using the Log of
Appended Documents (Form 2800).

Other Toxicity Modifying Regimen
NOTE: Question 342
The following other toxicity modifying regimen question is optional for non-U.S. centers.
Question 342: Was KGF (palifermin, Kepivance) started or is there a plan to use
it?
Check “yes” if KGF was started or planned. Check “no” if KGF was not started or
planned.
Check “masked trial” if the recipient is part of a KGF study where the agent the recipient
received is not known (e.g., placebo, drug, or other agent). Use the error correction
process to update the data field once the trial is over and the agent the recipient was
given is known.

Post-HCT Disease Therapy Planned as of Day 0
Question 343: Is this HCT part of a planned multiple (sequential) graft/HCT
protocol?
If the current HCT is part of a planned multiple graft/HCT protocol, check “yes.” The
HCT for which the form is being completed could be for any of the transplants within the
planned multiple graft/HCT protocol. The word “planned” should not be interpreted as:
if the recipient relapses, then the “plan” is to perform a subsequent HCT. If this HCT is
not part of a planned multiple graft/HCT protocol, check “no.”
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Question 344: Is additional post-HCT therapy planned?
If additional post-HCT therapy is planned according to the protocol or standard of care,
check “yes” even if the recipient does not receive the planned therapy. The word
“planned” should not be interpreted as: if the recipient relapses, then the “plan” is to
treat with additional therapy. If additional post-HCT therapy is not planned per protocol,
check “no” and continue with question 356.
NOTE: Questions 345-355
The following post-HCT planned therapy questions are optional for non-U.S. centers.
Questions 345-355: Additional post-HCT planned therapy
Indicate if the options listed on the form are intended to be part of the post-HCT planned
therapy according to the protocol or standard of care. Report other planned therapies in
the “other, specify” category.

Primary Disease for HCT
NOTE: Disease Classification Questions
The newest versions of the TED Forms use the World Health Organization (WHO)
disease classifications. The Disease Classification questions contain all of the
established WHO disease types and subtypes. The “other, specify” category should be
used only if the recipient’s disease is not one of the listed options. For more information
regarding disease classification, consult a transplant physician, contact your center’s
CIBMTR CRC, or visit the WHO website at: http://www.who.int/classifications/icd/en/.
Several of the Disease Classification questions ask for “Status at Transplantation.”
Although there are many interpretations of disease response criteria, when reporting
data to the CIBMTR, use the guidelines in this manual to determine disease
status. A majority of the disease response criteria are established by an international
working group. Citations of resources used to define disease responses are included
where applicable.
If the recipient’s status is unclear, consult with the transplant physician for further
information or contact your center’s CIBMTR CRC.
NOTE: Malignant vs. Non-malignant
Malignant diseases involve cells dividing without control that can spread to other parts
of the body through blood and lymph systems. These diseases are usually
characterized by unlimited, aggressive growth, invasion of surrounding tissues, and
metastasis.
Non-malignant diseases involve cell overgrowth, but lack the malignant properties of
cancer.

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The CIBMTR database disease codes are represented in parentheses after the disease
subtype on the Disease Classification questions and can be helpful in mapping
diagnosis [e.g., Myeloid Sarcoma (295)], and determining if the disease is malignant or
non-malignant. Disease codes (10-299) indicate a malignant disease, with the exception
of Paroxysmal Nocturnal Hemoglobinuria (PNH) (56). A disease code of (300) or above
indicates a non-malignant disease, with the exception of disease code (900), which could
indicate either a malignant or non-malignant disease.
If the indication for HCT is due to a combination of diseases or a transformation of one
disease to another, it may be necessary to report multiple disease classifications.
Tables 1 and 2 list how common examples of disease combinations and
transformations should be reported using the Disease Classification questions.
Table 1. Common Disease Combinations
Disease Combinations

Report primary
disease as:

FAN or SAA and AML
FAN or SAA and MDS
MYE and AMY

AML
MDS
MYE

Report disease
diagnosis date
of:
AML
MDS
MYE

Complete multiple
disease sections on the
Pre-TED?
No
No
No

Table 2. Common Disease Transformations
Disease
Transformation

Report primary
disease as:

Report disease
diagnosis date
of:

Complete multiple
disease sections on the
Pre-TED?

MDS or MPS to AML

AML

AML

Yes- AML and MDS/MPN

JMML to AML

AML

AML

Yes- AML and MDS/MPN
(select questions only)

NHL to another NHL

Second NHL
diagnosis

First NHL
diagnosis

No

CLL to NHL
(i.e., Richter’s
Syndrome)

NHL

CLL

Yes- Other Leukemias
and NHL

AML, acute myelogenous leukemia; AMY, amyloidosis; CLL, chronic lymphocytic leukemia; FAN, Fanconi anemia; MDS,
myelodysplastic syndrome; MPS, myeloproliferative disease; MYE, multiple myeloma; NHL, non-Hodgkin lymphoma; SAA, severe
aplastic anemia.

Question 356: Date of diagnosis for primary disease for HCT:
The date of diagnosis is important because the interval between diagnosis and HCT is
often a significant indicator for the recipient’s prognosis post-HCT.
Report the date of the first pathological diagnosis (e.g., bone marrow or tissue biopsy)
of the disease. Enter the date the sample was collected for examination. If the diagnosis
was determined at an outside center, and no documentation of a pathological or
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laboratory assessment is available, the dictated date of diagnosis within a physician
note may be reported. Do not report the date symptoms first appeared.
If the exact pathological diagnosis date is not known, use the process described in
General Instructions, Guidelines for Completing Forms.
If this is a subsequent HCT for a new malignancy (or other new indication), report the
date of diagnosis of the new malignancy.
Question 357: What was the primary disease for which the HCT was performed?
From the list provided, select the primary disease for which the recipient is receiving the
HCT and continue with the appropriate disease classification questions.

Acute Myelogenous Leukemia (AML)
Acute Myelogenous Leukemia (AML) is a cancer of the white blood cells. It is
characterized by the rapid proliferation of abnormal, immature myelocytes, known as
myeloblasts, in the bone marrow. This accumulation of blasts in the marrow prevents
the formation of healthy red blood cells, white blood cells, and/or platelets. Normal
myeloblasts develop into neutrophils, basophils, and eosinophils, which are all white
blood cells that fight infection. In AML, the leukemic myeloblasts do not fully develop
and are unable to fight infection. The symptoms of AML result from a drop in red blood
cell, platelet, and normal white blood cell counts caused by the replacement of normal
bone marrow with leukemic cells.
Certain prognostic indicators are associated with poorer outcomes. These include
advanced age (50+ years of age), AML arising from MDS or secondary/therapy-related
AML, and certain genetic mutations that are described in greater detail later in this
manual.
Question 358: Specify the AML classification
Indicate the disease classification at diagnosis; the older FAB classifications are shown
in parenthesis, e.g., (M0).
Question 359: Did AML transform from MDS or MPN?
AML often evolves from MDS or MPN. This transformation is typically distinguished by
the percentage of blasts in the bone marrow.
AML that transforms from MDS or MPN has a lower survival prognosis because of the
association with unfavorable cytogenetic abnormalities.
AML can also evolve from Juvenile Myelomonocytic Leukemia (JMML). JMML is a rare
form of chronic leukemia that affects young children, usually before the age of five.
JMML results from DNA mutations in cells called monocytes. Normal monocytes attack
invading microorganisms and assist lymphocytes in carrying out immune functions.
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Abnormal monocytes in JMML accumulate in the bone marrow and interfere with the
production of normal white blood cells, red blood cells, and platelets.
If AML transformed from MDS or MPN (including JMML), check “yes” and complete
both the AML and MDS/MPN disease classification sections (questions 480-572). If
AML did not transform from MDS or MPS, check “no.”
If MDS/MPN is suspected, but not confirmed by documented laboratory or pathologic
findings, or if there is documentation of MDS/MPN concurrent with AML, check “no.”
Question 360: Was disease (AML) therapy related?
Agents such as radiation or systemic therapy used to treat other diseases (e.g.,
Hodgkin lymphoma, non-Hodgkin lymphoma, or breast cancer) can damage the marrow
and lead to a secondary malignancy such as AML. If the diagnosis of AML is therapyrelated, check “yes.”
If the diagnosis of AML is not therapy-related, check “no.”
If AML was preceded by therapy-related MDS, check “no.”
If the recipient developed AML after an environmental exposure (e.g., exposure
to benzene), check “no.”
If it is unknown whether or not the diagnosis of AML was therapy-related, check
“unknown.”
Question 361: Did the recipient have a predisposing condition?
A predisposing condition is a condition that contributes to the susceptibility of
developing leukemia. Therefore, diagnosis of the condition increases the likelihood that
the recipient will develop leukemia. If the recipient has a documented history of a
predisposing condition, check “yes” and continue with question 362. If there is no history
of a predisposing condition or if predisposition is unknown, indicate “no” or “unknown”
and continue with question 364.
Questions 362-363: Specify condition:
Bloom syndrome is an autosomal recessive genetic disorder characterized by excessive
chromosome breakage and corresponding rearrangements, proportional dwarfism, and
sun sensitivity. The chromosomal instability seen in Bloom syndrome is generally
assumed to be responsible for these individuals’ predisposition to malignancy.
Down syndrome is also a chromosomal disorder (trisomy 21). It is characterized by an
additional chromosome 21. Down syndrome patients exhibit a particular set of facial
characteristics, growth deficiency, and cognitive impairment. Although Down syndrome
patients have a reduced risk of developing many common malignancies, they have an
increased risk of developing leukemia.
Fanconi anemia is a rare genetic blood disorder that prevents the body from producing
a sufficient number of new blood cells to function properly. Abnormal blood cells may
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also be produced. These patients are short in stature, exhibit skeletal anomalies, and
have an increased risk of developing solid tumors and leukemias.
Neurofibromatosis type 1, also known as von Recklinghausen disease, is an autosomal
dominant genetic disorder characterized by mutation of chromosome 17 resulting in the
inactivation of the NF1 gene. This results in abnormal growth and proliferation of neural
crest cells. Patients with neurofibromatosis type 1 often have multiple neurofibromas
(benign neural tumors), skeletal abnormalities, café au lait spots, Lisch nodules,
freckling in the axilla or groin, and/or optic nerve glioma. Patients with biallelic
inactivation of NF1 may have an increased risk of developing malignant neoplasms,
including rhabdomyosarcoma, pheochromocytoma, and, in children, myelodysplastic
syndrome and acute leukemia.
Indicate the recipient’s predisposing condition prior to the diagnosis of leukemia. If the
condition was “other,” specify the condition in question 363.
Question 364: Were cytogenetics tested (conventional or FISH)?
Cytogenetic analysis is the study of chromosomes. Cytogenetic assessment involves
testing blood or bone marrow for the presence of a known chromosomal abnormality
that reflects the recipient’s disease. Testing methods you may see include conventional
chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For
more information about cytogenetic testing and terminology, see Appendix R,
Cytogenetic Abbreviations and Terminology.
Table 3. Examples of AML cytogenetic findings categorized by prognosis
Favorable

Intermediate

t(15;17)
t(8;21)
inv(16) or t(16;16)

Normal
+8
t(9;11)
All other abnormalities

Poor
≥ 3 abnormalities
5- or 5q7- or 7qt(9;22)

Indicate if cytogenetic studies were obtained at any time prior to the start of the
preparative regimen.
If cytogenetic studies were obtained, check “yes” and continue with question 365.
If cytogenetic studies were not obtained or it is unknown if chromosome studies were
performed, indicate “no” or “unknown” and continue with question 402.
Question 365: Results of tests:
If cytogenetic studies identified abnormalities (any karyotype other than 46XX or 46XY),
indicate “abnormalities identified” and continue with question 366.
If cytogenetic studies yielded “no evaluable metaphases” or there were “no
abnormalities” identified, continue with question 402.
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Questions 366-401: Specify cytogenetic abnormalities identified at any time prior
to the start of the preparative regimen:
If question 365 indicates that abnormalities were identified, each of questions 366-400
must be answered as “yes” or “no.” Do not leave any response blank. Indicate “yes” for
each cytogenetic abnormality identified at any time prior to the start of the preparative
regimen. Indicate “no” for all options not identified by cytogenetic assessment at any
time prior to the start of the preparative regimen. If one or more abnormalities are best
classified as “other abnormality,” specify in question 401.
If ≥ 3 cytogenetic abnormalities were identified at any time prior to the start of the
preparative regimen, select “yes” for question 399 (complex, ≥ 3 distinct abnormalities)
and specify the corresponding abnormalities in questions 366-398. If any of these
abnormalities are not listed among 366-398, report “other abnormality,” and specify in
question 401. For example, if the karyotype included -7, +8, and -13, report “yes” for
questions 367, 373, 399, and 400-401. Complete the remaining indicators as “no” and do
not leave any response blank.
Question 402: Were tests for molecular markers performed (e.g., PCR)?
Molecular assessment involves testing blood or bone marrow for the presence of known
molecular markers associated with the recipient’s disease. Molecular assessments are
the most sensitive test for genetic abnormalities and involve amplifying regions of
cellular DNA by polymerase chain reaction (PCR), typically using RNA to generate
complementary DNA through reverse transcription (RT-PCR). The amplified DNA
fragments are compared to a control, providing a method of quantifying log increase of
genetic mutation transcripts. Each log increase is a 10-fold increase of gene transcript
compared to control.
Indicate if molecular studies were obtained at any time prior to the start of the
preparative regimen.
If molecular studies were obtained, check “yes” and continue with question 403.
If molecular studies were not obtained or it is not known if molecular studies were
performed, indicate “no” or “unknown” and continue with question 412.
Questions 403-411: Specify molecular markers identified at any time prior to the
start of the preparative regimen:
If question 402 indicates that tests for molecular markers were performed, then each of
questions 403-410 must be answered as “positive,” “negative,” or “not done.” Do not
leave any response blank. If tests identified a molecular marker other than those listed
in questions 403-409, use question 410 to report it. If question 410 is answered
“positive” or “negative,” specify the other molecular marker in question 411. Add an
additional instance in the FormsNet application for questions 410-411 if more than one
“other molecular marker” is identified.

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Table 4. Common molecular markers associated with AML
Molecular Abnormality

Characteristics

CEBPA

CEBPA, aka CCAAT/enhancer binding protein α,
is a transcription factor required for the
differentiation of granulocytes. Numerous CEBPA
mutations have been identified in relation to AML,
with the majority of patients displaying biallelic
mutations ultimately resulting in the down
regulation of gene activity. Decreased gene
activity results in decreased differentiation
potential for immature granulocytes. An
estimated 7-15% of AML patients have CEBPA
mutations. CEBPA mutations are generally found
in M1 and M2 subtypes in conjunction with
intermediate-risk cytogenetics. Studies show
association with more favorable outcomes.
Lin L, Chen C, Lin D, Tsay W, Tang J, Yeh Y, Shen H, Su F, Yao M,
Huang S, Tien H. (2005). Characterization of CEBPA Mutations in
Acute Myeloid Leukemia: Most patients with CEBPA mutations have
biallelic mutations and show a distinct immunophenotype of the
leukemic cells. Clin Cancer Res, 11(4):1372-9.

FLT3-D835 point mutation

FLT3 encodes a receptor tyrosine kinase. The
FLT3-D835 point mutation, aka FLT3-TKD, is an
activating mutation impacting tyrosine-kinase
domains. FLT3 mutations are found in up to onethird of all AML patients. The clinical significance
of TKD activation remains unclear. FLT3-D385
mutations are often found in conjunction with
other mutations. Overall, FLT3-D385 is not
considered a favorable or poor prognostic
indicator. However, in certain combinations with
other mutations, there are associations with both
improved and diminished survival.
Mead AJ, Linch DC, Hills RK, Wheatley K, Burnett AK, Gale RE.
(2007). FLT3 tyrosine kinase domain mutations are biologically
distinct from and have a significantly more favorable prognosis than
FLT3 internal tandem duplications in patient with acute myeloid
leukemia. Blood, 110(4): 1262-70.
Whitman SP, Ruppert AS, Radmacher, MD, et al. (2008). FLT3
D835/I836 mutations are associated with poor disease-free survival
and a distinct gene-expression signature among younger adults with
de novo cytogenetically normal acute myeloid leukemia lacking
FLT3 internal tandem duplications. Blood, 111(3):1552-59.

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Table 4. Common molecular markers associated with AML (cont.)
Molecular Abnormality

Characteristics

FLT3-ITD mutation

FLT3 encodes a receptor tyrosine kinase. The
FLT3-ITD (internal tandem duplication) interferes
with certain down regulation functions within
receptor tyrosine kinases, leading to activation of
TK activity. FLT3 mutations are found in up to 1/3
of all AML patients. FLT3-ITD is considered a
poor prognostic factor. Sorafenib (Nexavar) has
been shown to initially improve disease response
in FLT3-ITD-positive AML.
Man CH, Fung TK, Ho C, et al. (2011). Sorafenib treatment of FLTITD+ acute myeloid leukemia: favorable initial outcome and
mechanisms of subsequent non-responsiveness associated with the
emergence of a D835 mutation. Blood, 119(22):5133-43.

IDH1

Isocitrate Dehydrogenase (IDH) is an oxidative
enzyme involved in the citric acid cycle. IDH1
mutations result in incorrect catalytic activity,
leading to increased levels of an oncometabolite,
2-hydroxyglutarate. The pathologic activity of
IDH1 mutations is still being studied, but it has
been suggested that IDH mutations may be a
distinct mechanism in AML pathogenesis.
Research models show they may cause an
accumulation of hematopoietic progenitor cells.
Early research suggests IDH1 mutation may be a
less favorable prognostic indicator.
Marucci G, Maharry K, Wu YZ, et al. (2010). IDH1 and IDH2 Gene
Mutations Identify Novel Molecular Subsets Within De Novo
Cytogenetically Normal Acute Myeloid Leukemia: A Cancer and
Leukemia Group B Study. J Clin Oncol, 28(14):2348-55.

IDH2

Isocitrate Dehydrogenase (IDH) is an oxidative
enzyme involved in the citric acid cycle. IDH2 is a
mitochondrial homolog to IDH1. Much like IDH1
mutations, IDH2 mutations result in incorrect
catalytic activity, leading to increased levels of
(D)-2-hydroxyglutarate. The pathologic activity of
IDH2 mutations are still being studied, but it has
been suggested that IDH mutations may be a
distinct mechanism in AML pathogenesis;
research models show they may cause an
accumulation of hematopoietic progenitor cells.
Early research suggests IDH2 mutation may be a
more favorable prognostic indicator, unlike IDH1
mutation, though there may be differences based
on where the IDH2 mutation occurs in the gene.
Green CL, Evans CM, Zhao L, et al. (2011).The prognostic
significance of IDH2 mutations in AML depends on the location of
the mutation. Blood, 118(2):409-12.
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Table 4. Common molecular markers associated with AML (cont.)
Molecular Abnormality

Characteristics

KIT

KIT encodes a receptor tyrosine kinase. The KIT
mutations at exons 8 and 17 are associated with
activation of encoded proteins, resulting in
activation impacting tyrosine-kinase domains.
Patients with t(8;21) and inv(16) cytogenetics are
frequently screened for KIT mutations, which
adversely affect prognosis in these patients.
Döhner K, Döhner H. (2008).Molecular characterization of acute
myeloid leukemia. Haematologica, 93(7):976-82.

NPM1

NPM1 encodes a protein responsible for multiple
cellular functions, including the regulation of the
ARF-p53 tumor suppressor pathway. Mutations
in NPM1 result in gene over-expression and
subsequent inactivation of ARF-p53 tumor
suppression pathway. NPM1 mutations are one
of the most common molecular markers seen in
AML and are associated with improved survival.
Varhaak RGW, Goudswaard CS, van Putten W, et al.
(2005).Mutations in nucleophosmin (NPM1) in acute myeloid
leukemia (AML): association with other gene abnormalities and
previously established gene expression signatures and their
favorable prognostic significance. Blood, 106(12):3747-54.

Other molecular marker

Assessments for other molecular markers known
or believed to be associated with AML may be
performed. If these studies are performed,
indicate “yes” and specify in question 411.

Question 412: What was the disease status (based on hematologic test results)?
Indicate the disease status of AML at the last assessment prior to the start of the
preparative regimen.
Table 5. Disease Status of AML
Disease Status

Definition

Primary Induction Failure (PIF)
If yes, continue with question 418.

The patient received treatment for AML but
never achieved complete remission at
anytime. PIF is not limited by the number of
unsuccessful treatments; this disease status only
applies to recipients who have never been in
complete remission.

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Table 5. Disease Status of AML (cont.)
Disease Status

Definition

Complete Remission (CR)
If yes, continue with question 413.

Hematologic complete remission is defined as
meeting all of the following response criteria for
at least four weeks.
< 5% blasts in the bone marrow
No blasts with Auer rods
Normal maturation of all cellular
components in the bone marrow
No extramedullary disease (e.g., CNS,
soft tissue disease)
Neutrophils ≥ 1,000/µL
Platelets ≥ 100,000/µL
Transfusion independent
In some cases, there may not be a four-week
interval between completion of therapy and the
pre-transplant disease assessment. In this case,
CR should still be reported as the status at
transplant since it represents the “best
assessment” prior to HCT. This is an exception
to the criteria that CR be durable beyond four
weeks; the pre-transplant disease status should
not be changed based on early relapse or
disease assessment post-transplant.
Include recipients with persistent cytogenetic or
molecular abnormalities who meet the above CR
criteria for hematologic CR.
Include recipients meeting the above CR criteria
regardless of how many courses of therapy were
required to achieve CR.
NOTE: For recipients with MDS that
transformed to AML
If the recipient has residual MDS following
treatment for AML, report the AML disease
status as either PIF or relapse (i.e., the recipient
cannot be in an AML CR if there is evidence of
MDS at the time of assessment).
The number of this complete remission can be
determined by using the following guidelines:
1st CR: no prior relapse
2nd CR: one prior relapse
3rd or higher: two or more prior relapses

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Table 5. Disease Status of AML (cont.)
Disease Status

Definition

Relapse (REL)
If yes, continue with question 417.

No Treatment
If yes, continue with question 418.

Relapse is defined as the recurrence of disease
after CR, meeting the following criteria:
≥ 5% blasts in the marrow or peripheral
blood
Extramedullary disease
Reappearance of cytogenetic and/or
molecular abnormalities associated with
diagnosis that, in the judgment of a
physician, are at a level representing
relapse
Disease presence determined by a
physician upon clinical assessment
The number of this relapse can be determined
by using the following guidelines:
1st relapse: one prior CR
2nd relapse: two prior CRs
3rd or higher: three or more CRs
Do not include a partial response (PR) when
determining number of relapse. Recipients who
achieve a PR to treatment should be classified
as either PIF or relapse; PR in AML is generally
of short duration and is unlikely to predict clinical
benefit.
The recipient was diagnosed with acute
leukemia and never received therapeutic agents;
include patients who have received only
supportive therapy, including growth factors
and/or blood transfusions.
NOTE: For recipients with MDS that
transformed to AML
“No treatment” may apply if the recipient’s MDS
was treated, then transformed to AML, and the
recipient proceeded directly to transplant without
receiving treatment for their AML.

Question 413: How many cycles of induction therapy were required to achieve
CR?
Chemotherapy is initially given as induction therapy intended to bring the disease into
remission. Recipients usually have one to two cycles of induction therapy; disease
prognosis is considered less favorable if the patient fails to achieve remission with the
first induction therapy and even poorer if patients fail two or more induction therapies.1
An example of a common induction therapy for all AML subtypes (except M3) is a
combination of an anthracycline and cytarabine, commonly known as “7+3.” In this
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regimen, cytarabine is typically administered for seven days at a dose of
100 mg/m2/day. The anthracycline (usually daunorubicin at 45 to 60 mg/m2/day or
idarubicin at 12 mg/m2/day) is generally given on the first three days the cytarabine is
given.
The second phase of chemotherapy is known as consolidation therapy. The goal of
consolidation therapy is to destroy any remaining leukemia cells and sustain remission.
An example of a common consolidation therapy for all AML subtypes (except M3) is
high-dose cytarabine, commonly referred to as “HiDAC.” In this regimen, cytarabine is
typically administered at a dose exceeding 10 g/m2 per cycle.
Maintenance chemotherapy may follow consolidation therapy. Maintenance
chemotherapy is given in lower doses and is intended to prolong a remission.
Maintenance therapy is used less commonly for the treatment of AML than other
malignancies. Treatment may also be administered for relapsed disease. Much like
induction therapy, treatment for relapse is intended to bring the disease back into
remission. Systemic therapeutic agents used to induce remission following relapse often
differ from those used in the initial induction, since the disease is often resistant to many
of the agents used earlier in the disease course and is considered high-risk with a poor
prognosis. Allogeneic HCT is often considered the only potential “cure” for relapsed
disease.
Indicate the number of cycles of induction therapy that were required to achieve the first
CR.
1

Ravandi F, Cortes J, Faderl S, et al. (2010). Characteristics and outcome of patients with acute myeloid leukemia refractory to one
cycle of high-dose cytarabine-based induction therapy. Blood, 116(26):5818-23.

Question 414: Was the recipient in molecular remission?
Molecular assessment involves testing blood or bone marrow for the presence of known
molecular markers associated with the recipient’s disease. Molecular assessments are
the most sensitive test for genetic abnormalities and involve amplifying regions of
cellular DNA by polymerase chain reaction (PCR), typically using RNA to generate
complementary DNA through reverse transcription (RT-PCR).
Molecular remission is a treatment response in which no minimal residual disease in the
blood and/or marrow can be detected by molecular methods (e.g., PCR).
If molecular abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If molecular abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”

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Indicate “unknown” if molecular abnormalities associated with the recipient’s disease
were identified previously and no molecular assessment was performed prior to the start
of the preparative regimen.
Indicate “not applicable” if one of the following applies:
No molecular assessments were performed at any time prior to the start of the
preparative regimen.
Molecular abnormalities associated with the recipient’s disease were not
identified on previous testing and no molecular abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 415: Was the recipient in remission by flow cytometry?
Flow cytometry assessment is a method of analyzing peripheral blood, bone marrow, or
tissue preparations for multiple unique cell characteristics. Its primary clinical purpose in
the setting of leukemias is to quantify blasts in the peripheral blood or bone marrow, or
to identify unique cell populations through immunophenotyping. Flow cytometry
assessment may also be referred to as “MRD,” or minimal residual disease, testing.
Flow cytometric remission is a treatment response in which no blasts can be detected.
If flow cytometric abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If flow cytometric abnormalities associated with the recipient’s disease were identified at
the last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if flow cytometric abnormalities associated with the recipient’s
disease were identified previously and no flow cytometry assessment was performed
prior to the start of the preparative regimen.
Indicate “not applicable” if one of the following applies:
No flow cytometry assessments were performed at any time prior to the start of
the preparative regimen.
Flow cytometric abnormalities were not identified on previous testing and no flow
cytometric abnormalities were identified at the last evaluation prior to the start of
the preparative regimen.
Question 416: Was the recipient in cytogenetic remission?
Cytogenetic assessment involves testing blood or bone marrow for the presence of a
known cytogenetic abnormalities that reflect the recipient’s disease. FISH is categorized
with cytogenetics. Although often used for finding specific features in DNA, FISH is not
as sensitive as molecular methods, even though the markers identified may be the
same.
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Cytogenetic remission is a treatment response where both of the following criteria are
met:
The karyotype reverts to normal, and
There are no clonal chromosomal abnormalities detected in the blood and/or
marrow.
If cytogenetic abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If cytogenetic abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if cytogenetic abnormalities associated with the recipient’s disease
were identified previously and no cytogenetic assessment was performed prior to the
start of the preparative regimen.
Indicate “not applicable” if one of the following applies:
No cytogenetic assessments were performed at any time prior to the start of the
preparative regimen.
Cytogenetic abnormalities were not identified on previous testing and no
cytogenetic abnormalities were identified at the last evaluation prior to the start of
the preparative regimen.
Continue with question 418.
Question 417: Date of most recent relapse:
Enter the date of the most recent relapse prior to the start of the preparative regimen. If
reporting a pathological evaluation (e.g., bone marrow) or blood/serum assessment
(e.g., CBC, peripheral blood smear), enter the date the sample was collected. If
extramedullary disease was detected by radiographic examination (e.g., X-ray, CT
scan, MRI scan, PET scan), enter the date the imaging took place. If the physician
determines cytogenetic or molecular relapse, enter the date the sample was collected
for cytogenetic or molecular evaluation. If the physician determines evidence of relapse
following a clinical assessment during an office visit, report the date of assessment.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.
Question 418: Date assessed
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. The date reported should be that of the most disease-specific
assessment within the pre-transplant work-up period (approximately 30 days). Clinical
and hematologic assessments include pathological evaluation (e.g., bone marrow
biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and
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laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician
evaluation and physical examination. Enter the date the sample was collected for
pathological and laboratory evaluations; enter the date the imaging took place for
radiographic assessments.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia (ALL) is a cancer of the white blood cells. It is
characterized by the rapid proliferation of abnormal, immature lymphocytes, known as
lymphoblasts, in the bone marrow. This accumulation of blasts in the marrow prevents
the formation of healthy red blood cells, white blood cells and/or platelets. Normal
lymphoblasts develop into B and T lymphocytes that fight infection. In ALL, the leukemic
lymphoblasts do not fully develop and therefore cannot fight infection. The symptoms of
ALL are caused by the replacement of normal bone marrow with leukemic cells,
resulting in a drop in red blood cells, platelets, and normal white blood cells. It is
estimated that 80-85% of ALL cases occur in children, with peak incidence of pediatric
ALL at age 5. Biologically, adult and pediatric ALL are very different. Pediatric cases
are more often characterized by favorable prognostic indicators including a precursor Bcell population, TEL/AML1 fusion gene, and/or hyperdiploidy; adult cases are more
often characterized by poor prognostic indicators including a precursor T-cell population
and/or BCR/ABL fusion gene.1
1

Sallan S. Myths and Lessons from the Adult/Pediatric Interface in Acute Lymphoblastic Leukemia. ASH Education Book, 1st edition.
2006:128-32.

Question 419: Specify ALL classification
Indicate the disease classification at diagnosis.
Due to the aggressive nature of precursor T- and precursor B-cell lymphoblastic
lymphoma (or lymphoma/leukemia), the primary disease reported for recipients with
these malignancies should be acute lymphoblastic leukemia (T-cell lymphoblastic
leukemia/lymphoma or B-cell ALL, NOS {L1/L2}).
If the cytogenetic or molecular abnormalities present at diagnosis are listed on the PreTED form, check the sub-type rather than “B-cell ALL, NOS” option.
Question 420: Were tyrosine kinase inhibitors (i.e., imatinib mestylate) given for
pre-HCT therapy at any time prior to the start of the preparative regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B. Indicate
“yes” or “no.”
Question 421: Were cytogenetics tested (conventional or FISH)?
Cytogenetic analysis is the study of chromosomes. Cytogenetic assessment involves
testing blood or bone marrow for the presence of a known chromosomal abnormality
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that reflects the recipient’s disease. Testing methods include conventional chromosome
analysis (karyotyping) or fluorescence in situ hybridization (FISH). For more information
about cytogenetic testing and terminology, see Appendix R, Cytogenetic Abbreviations
and Terminology.
Table 6. Examples of ALL cytogenetic findings categorized by prognosis (Adult
precursor B-cell ALL)
Favorable
High hyperdiploidy (51-65
chromosomes)

Intermediate
Normal
11q abnormalities
del(6q)
del(17p)
del(9p)
del(12p)
-13/del(13q)
t(14q32)
t(10;14)
Low hyperdiploidy (47-50
chromosomes)
Tetraploidy (> 80
chromosomes)

Poor
-7/del(7p)
+8
11q23 abnormalities/MLL
t(1;19)
t(17;19)
t(5;14)
t(9;22)
Very Poor
≥ 5 abnormalities
t(4;11)
t(8;14)

Pullarkat V, Slovak ML, Kopecky KJ, Forman SJ, Appelbaum FR. Impact of cytogenetics on the outcome of adult acute
lymphoblastic leukemia: results of Southwest Oncology Group 9400 study. Blood. 2008;111(5):2563-72.

Indicate if cytogenetic studies were obtained at any time prior to the start of the
preparative regimen.
If cytogenetic studies were obtained, check “yes” and continue with question 422.
If cytogenetic studies were not obtained, or if it is unknown if chromosome studies were
performed, indicate “no” or “unknown” and continue with question 450.
Question 422: Results of test
If cytogenetic studies identified abnormalities (any karyotype other than 46XX or 46XY),
indicate “abnormalities identified” and continued with question 423.
If cytogenetic studies yielded “no evaluable metaphases” or there were “no
abnormalities” identified, continue with question 450.
Questions 423-449: Specify abnormalities
If question 422 indicates that abnormalities were identified, each of questions 423-448
must be answered as “yes” or “no.” Do not leave any response blank. Indicate “yes” for
each cytogenetic abnormality identified at any time prior to the start of the preparative
regimen in questions 423-448; indicate “no” for all options not identified on cytogenetic
assessment at any time prior to the start of the preparative regimen. If one or more
abnormalities are best classified as “other abnormality,” specify in question 449.
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If ≥ 3 cytogenetic abnormalities are identified at any time prior to the start of the
preparative regimen, select “yes” for question 447 (complex, ≥ 3 distinct abnormalities)
and specify the corresponding abnormalities in questions 423-446. If any of these
abnormalities are not listed among 423-446, report “other abnormality,” and specify in
question 449. For example, if the karyotype included -7, +8, and -13, report “yes” for
questions 423, 425, 447, and 448-449. Answer the remaining questions “no” and do not
leave any response blank.
Question 450: Were tests for molecular markers performed (e.g., PCR)?
Molecular assessment involves testing blood or bone marrow for the presence of known
molecular markers associated with the recipient’s disease. Molecular assessments are
the most sensitive test for genetic abnormalities and involve amplifying regions of
cellular DNA by polymerase chain reaction (PCR), typically using RNA to generate
complementary DNA through reverse transcription (RT-PCR). The amplified DNA
fragments are compared to a control, providing a method of quantifying log increase of
genetic mutation transcripts. Each log increase is a 10-fold increase of gene transcript
compared to control.
Indicate if molecular studies were obtained at any time prior to the start of the
preparative regimen.
If molecular studies were obtained, check “yes” and continue with question 451.
If molecular studies were not obtained or it is not known if molecular studies were
performed, indicate “no” or “unknown” and continue with question 455.
Questions 451-454: Specify abnormalities
If question 450 indicates that tests for molecular markers were performed, then each of
questions 451-453 must be answered as “positive,” “negative,” or “not done.” Do not
leave any response blank. If question 453 is answered “positive” or “negative,” specify
the molecular marker identified in question 454. If more than one “other molecular
marker” is identified, add an additional instance in the FormsNet application for
questions 453-454.

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Table 7. Common molecular markers associated with ALL
Molecular Abnormality
BCR-ABL

Characteristics
BCR-ABL, aka Philadelphia
chromosome, refers to the tyrosine
kinase gene fusion resulting from the
translocation of material from
chromosome 9 (ABL) onto chromosome
22 (BCR). Molecular weight varies
depending on exact location of the
translocation; isoform p190 is typically
seen in ALL. Tyrosine kinase inhibitor
therapies such as imatinib mesylate
(Gleevec) target and block ABL from
fusing with BCR. Presence of BCR-ABL
gene fusion is associated with poorer
outcomes.
Wassmann B, Pfeifer H, Scheuring UJ, et al. (2004). Early
prediction of response in patients with relapsed or
refractory Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ALL) treated with imatinib.
Blood, 103(4):1495-8.

TEL-AML/AML1

TEL-AML1, aka ETV6-RUNX1, is a
fusion gene resulting from the
translocation of chromosomes 12 and 21.
It is the most common fusion gene seen
in childhood precursor B-cell ALL.
Research in murine models shows that
cell lines expressing TEL-AML1
proliferate more slowly than the nonexpressing cell lines, but evade inhibition
of proliferation typically regulated by
tissue growth factor ß (TGF-ß), ultimately
leading to the growth of the leukemic cell
population. TEL-AML1 is considered a
favorable prognostic indicator.
Ford AM, Palmi C, Bueno C, et al. (2009). The TEL-AML1
leukemia fusion gene dysregulates the TGF-ß pathway in
early B lineage progenitor cells. J Clin Invest, 119(4):82636.
Jamil A, Kahwash S, Ruymann FB, Klopfenstein KJ.
(2000). TEL/AML-1 fusion gene: its frequency and
prognostic significance in childhood acute lymphoblastic
leukemia. Cancer Genet Cytogenet, 122(2):73-8.

Other molecular marker

Assessments for other molecular
markers known or believed to be
associated with ALL may be performed. If
these studies were performed, indicate
“yes” and specify in question 454.

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Question 455: What was the disease status (based on hematological test
results)?
Indicate the disease status of ALL at the last evaluation prior to the start of the
preparative regimen.
Table 8. Disease Status of ALL
Disease Status

Definition

Primary Induction Failure (PIF)
If yes, continue with question
461.

Complete Remission (CR)
If yes, continue with question
456.

The patient received treatment for ALL but never
achieved complete remission at anytime. PIF is
not limited by the number of unsuccessful
treatments; this disease status only applies to
recipients who have never been in complete
remission.
Hematologic complete remission is defined as
meeting all of the following response criteria for at
least four weeks.
< 5% blasts in the bone marrow
Normal maturation of all cellular
components in the bone marrow
No extramedullary disease (e.g., CNS, soft
tissue disease)
Neutrophils ≥ 1,000/µL
Platelets ≥ 100,000/µL
Transfusion independent
In some cases, there may not be a four-week
interval between completion of therapy and the
pre-transplant disease assessment; in this case,
CR should still be reported as the status at
transplant, since it represents the “best
assessment” prior to HCT. This is an exception to
the criteria that CR be durable beyond four weeks;
the pre-transplant disease status should not be
changed based on early relapse or disease
assessment post-transplant.
Include recipients with persistent cytogenetic or
molecular abnormalities who meet the above CR
criteria for hematologic CR.
Include recipients meeting the above CR criteria
regardless of how many courses of therapy were
required to achieve CR.
The number of this complete remission can be
determined by using the following guidelines:
1st CR: no prior relapse
2nd CR: one prior relapse
3rd or higher: two or more prior relapses

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Table 8. Disease Status of ALL (cont.)
Disease Status

Definition

Relapse (REL)
If yes, continue with question
460.

No Treatment
If yes, continue with question
461.

Relapse is defined as the recurrence of disease
after CR, meeting the following criteria:
≥ 5% blasts in the marrow or peripheral
blood
Extramedullary disease
Reappearance of cytogenetic and/or
molecular abnormalities associated with
diagnosis that, in the judgment of a
physician, are at a level representing
relapse
Disease presence determined by a
physician upon clinical assessment
The number of this relapse can be determined by
using the following guidelines:
1st relapse: one prior CR
2nd relapse: two prior CRs
3rd or higher: three or more CRs
Do not include a partial response (PR) when
determining number of relapse. Recipients who
achieve a PR to treatment should be classified as
either PIF or relapse. PR in ALL is generally of
short duration and is unlikely to predict clinical
benefit.
The recipient was diagnosed with acute leukemia
and never received therapeutic agents. Include
patients who have received only supportive
therapy, including growth factors and/or blood
transfusions.

Question 456: How many cycles of induction therapy were required to achieve
CR?
Chemotherapy is initially given as induction therapy intended to bring the disease into
remission. Recipients usually have one to two cycles of induction therapy. An example
of a common induction therapy for precursor B-cell ALL in children with higher-risk
prognostic indicators is a combination of vincristine, prednisone, an anthracycline, and
L-asparaginase given over 4-6 weeks. Patients with a rapid response, defined as < 5%
blasts within 7 to 14 days of starting induction, have improved outcomes. 1
1

Gaynon PS, Desai AA, Bostrom BC, et al. Early response to therapy and outcome in childhood acute lymphoblastic leukemia: a
review. Cancer. 1997;80(9):1717-26.

The second phase of chemotherapy is known as consolidation therapy. The goal of
consolidation therapy is to destroy any remaining leukemia cells and sustain remission.
An example of a consolidation therapy for precursor B-cell ALL in children is
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daunorubicin and cytarabine; several studies support the use of consolidation therapy in
ALL.
Maintenance therapy typically involves daily doses of mercaptopurine and weekly doses
of methotrexate. Treatment continues for 2-3 years for most children with ALL.
Treatment may also be administered for relapsed disease. Much like induction therapy,
treatment for relapse is intended to bring the disease back into remission. Systemic
therapeutic agents used to induce remission following relapse often differ from those
used during initial induction, since the disease is considered high-risk with a poor
prognosis and is often resistant to many of the agents used earlier in the disease
course. Allogeneic HCT is often considered the only potential “cure” for relapsed
disease, if the patient has not already been transplanted.
Indicate the number of cycles of induction therapy that were required to achieve the first
CR.
Question 457: Was the recipient in molecular remission?
Molecular assessment involves testing blood or bone marrow for the presence of known
molecular markers associated with the recipient’s disease. Molecular assessments are
the most sensitive test for genetic abnormalities and involve amplifying regions of
cellular DNA by polymerase chain reaction (PCR), typically using RNA to generate
complementary DNA through reverse transcription (RT-PCR).
Molecular remission is a treatment response in which no minimal residual disease in the
blood and/or marrow can be detected by molecular methods (e.g., PCR).
If molecular abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If molecular abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if molecular abnormalities associated with the recipient’s disease
were identified previously and no molecular assessment was performed prior to the start
of the preparative regimen.
Indicate “not applicable” if one of the following applies:
No molecular assessments were performed at any time prior to the start of the
preparative regimen.
Molecular abnormalities were not identified on previous testing and no molecular
abnormalities were identified at the last evaluation prior to the start of the
preparative regimen.

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Question 458: Was the recipient in remission by flow cytometry?
Flow cytometry assessment is a method of analyzing peripheral blood, bone marrow, or
tissue preparations for multiple unique cell characteristics. Its primary clinical purpose in
the setting of leukemias is to quantify blasts in the peripheral blood or bone marrow, or
to identify unique cell populations through immunophenotyping. Flow cytometry
assessment may also be referred to as “MRD,” or minimal residual disease, testing.
Flow cytometric remission is a treatment response in which no blasts can be detected.
If flow cytometric abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If flow cytometric abnormalities associated with the recipient’s disease were identified at
the last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if flow cytometric abnormalities associated with the recipient’s
disease were identified previously and no flow cytometry assessment was performed
prior to the start of the preparative regimen.
Indicate “not applicable” if one of the following applies:
No flow cytometry assessments were performed at any time prior to the start of
the preparative regimen.
Flow cytometric abnormalities were not identified on previous testing and no flow
cytometric abnormalities were identified at the last evaluation prior to the start of
the preparative regimen.
Question 459: Was the recipient in cytogenetic remission?
Cytogenetic assessment involves testing blood or bone marrow for the presence of
known cytogenetic abnormalities that reflect the recipient’s disease. FISH is categorized
with cytogenetics. Although often used for finding specific features in DNA, FISH is not
as sensitive as molecular methods, even though the markers identified may be the
same.
Cytogenetic remission is a treatment response where both of the following criteria are
met:
The karyotype reverts to normal, and
There are no clonal chromosomal abnormalities detected in the blood and/or
marrow.
If cytogenetic abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”

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If cytogenetic abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if cytogenetic abnormalities associated with the recipient’s disease
were identified previously and no cytogenetic assessment was performed prior to the
start of the preparative regimen.
Indicate “not applicable” if one of the following applies:
No cytogenetic assessments were performed at any time prior to the start of the
preparative regimen.
Cytogenetic abnormalities were not identified on previous testing and no
cytogenetic abnormalities were identified at the last evaluation prior to the start of
the preparative regimen.
Continue with question 461.
Question 460: Date of most recent relapse:
Enter the date of the most recent relapse prior to the start of the preparative regimen. If
reporting a pathological evaluation (e.g., bone marrow) or blood/serum assessment
(e.g., CBC, peripheral blood smear), enter the date the sample was collected. If
extramedullary disease was detected by radiographic examination (e.g., X-ray, CT
scan, MRI scan, PET scan), enter the date the imaging took place. If the physician
determines cytogenetic or molecular relapse, enter the date the sample was collected
for cytogenetic or molecular evaluation. If the physician determines evidence of relapse
following a clinical assessment during an office visit, report the date of assessment.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.
Question 460: Date assessed
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. The date reported should be that of the most disease-specific
assessment within the pre-transplant work-up period (approximately 30 days). Clinical
and hematologic assessments include pathological evaluation (e.g., bone marrow
biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and
laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician
evaluation and physical examination. Enter the date the sample was collected for
pathological and laboratory evaluations; enter the date the imaging took place for
radiographic assessments.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

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Other Acute Leukemia
Questions 462-463: Specify other acute leukemia classification
Indicate the other acute leukemia disease classification at diagnosis. If the subtype is
not listed, report as “other leukemia” and specify the reported disease.
Acute undifferentiated leukemia is a type of AML characterized by immature
predominating cells that cannot be classified.
Biphenotypic, bilineage, or hybrid leukemias have characteristics
representative of both myeloid and lymphoid lineages.
Mast cell leukemia is characterized by an increased number of tissue mast
cells in the peripheral blood.
Question 464: What was the disease status (based on hematological test
results)?
Indicate the disease status of acute leukemia at the last evaluation prior to the start of
the preparative regimen.
Table 9. Disease Status of Acute Leukemia
Disease Status
Primary Induction Failure (PIF)

Complete Remission (CR)

Definition
The patient received treatment for acute leukemia
but never achieved complete remission at any
time. PIF is not limited by the number of
unsuccessful treatments; this disease status only
applies to recipients who have never been in
complete remission.
Hematologic complete remission is defined as
meeting all of the following response criteria for at
least four weeks.
< 5% blasts in the bone marrow
Normal maturation of all cellular
components in the bone marrow
No extramedullary disease (e.g., CNS, soft
tissue disease)
Neutrophils ≥ 1,000/µL
Platelets ≥ 100,000/µL
Transfusion independent
In some cases, there may not be a four-week
interval between completion of therapy and the
pre-transplant disease assessment; in this case,
CR should still be reported as the status at
transplant, since it represents the “best
assessment” prior to HCT. This is an exception to

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Table 9. Disease Status of Acute Leukemia (cont.)
Disease Status
Complete Remission (CR)
(cont.)

Definition
the criteria that CR be durable beyond four weeks;
the pre-transplant disease status should not be
changed based on early relapse or disease
assessment post-transplant.
Include recipients with persistent cytogenetic or
molecular abnormalities who meet the above CR
criteria for hematologic CR.
Include recipients meeting the above CR criteria
regardless of how many courses of therapy were
required to achieve CR.

Relapse (REL)

The number of this complete remission can be
determined by using the following guidelines:
1st CR: no prior relapse
2nd CR: one prior relapse
3rd or higher: two or more prior relapses
Relapse is defined as the recurrence of disease
after CR, meeting the following criteria:
≥ 5% blasts in the marrow or peripheral
blood
Extramedullary disease
Reappearance of cytogenetic and/or
molecular abnormalities associated with
diagnosis that, in the judgment of a
physician, are at a level representing
relapse
Disease presence determined by a
physician upon clinical assessment
The number of this relapse can be determined by
using the following guidelines:
1st relapse: one prior CR
2nd relapse: two prior CRs
3rd or higher: three or more CRs

No Treatment

Do not include a partial response (PR) when
determining number of relapse. Recipients who
achieve a PR to treatment should be classified as
either PIF or relapse; PR in acute leukemia is
generally of short duration and is unlikely to
predict clinical benefit.
The recipient was diagnosed with acute leukemia
and never received therapeutic agents; include
patients who have received only supportive
therapy, including growth factors and/or blood
transfusions.
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Question 465: Date assessed
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. The date reported should be that of the most disease-specific
assessment within the pre-transplant work-up period (approximately 30 days). Clinical
and hematologic assessments include pathological evaluation (e.g., bone marrow
biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and
laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician
evaluation and physical examination. Enter the date the sample was collected for
pathological and laboratory evaluations; enter the date the imaging took place for
radiographic assessments.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Chronic Myelogenous Leukemia (CML)
Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid
white blood cells. It is characterized by increased proliferation of immature white blood
cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and
bone marrow. Normal blasts develop into white blood cells that fight infection. The
symptoms of CML are caused by the replacement of normal bone marrow with leukemic
cells, resulting in fewer red blood cells, platelets, and normal white blood cells.
Question 466: Specify CML classification
Indicate the CML disease classification at diagnosis. The WHO disease classification
requirements state that a diagnosis of CML must include the following: Philadelphia
chromosome, complex variation and/or variant form, or BCR/ABL gene rearrangement
(see table 7 below). Evidence of these chromosomal abnormalities may be found at any
time between diagnosis and the start of the preparative regimen.
Report the combination that best describes the chromosomal abnormalities. If none of
the listed abnormalities are identified, but CML is suspected, report under
“Myelodysplastic (MDS)/Myeloproliferative (MPN)” and indicate “Atypical chronic
myeloid leukemia” as the detailed disease classification (questions 480, 577, and 579).
Table 10. CML Classification Requirements
Term
Philadelphia chromosome
t(9;22)(q34;q11)
Complex variation

Variant form

Definition
An exchange of genetic material between
region q34 of chromosome 9 and region q11 of
chromosome 22.
Translocation of three or more chromosomes,
one of which must be chromosome 22 [e.g.,
t(3; 9; 22)].
Any translocation involving 22q11, or 22.q11.2
in which CML is the suspected diagnosis [e.g.,
t(13; 22)(p3;q11)].

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Question 467: Did recipient receive treatment prior to this HCT?
If the recipient received therapy to treat CML prior to this HCT, check “yes” and continue
with question 468. If the recipient did not receive therapy to treat CML, check “no” and
continue with question 474.
Questions 468-473: CML treatment
Indicate the therapy the recipient received to treat CML prior to this HCT. If the
recipient’s treatment consisted of a combination of chemotherapeutic agents, check the
“combination chemotherapy” box and each drug included in the combination from the
list provided. The “other, specify” category should only be used if the drug is not one of
the listed options. For example, if the recipient received a combination of interferon and
cytarabine, check all of the following: “combination chemotherapy,” “interferon,” and
“other, specify: cytarabine.”
Questions 474: What was the disease status at last evaluation prior to the start of
the preparative regimen?
Indicate the disease status of CML at the last evaluation prior to the start of the
preparative regimen.
Table 11. Disease Status of CML
Disease Response: Phase
Complete Hematologic
Remission (CR)
If yes, also complete questions
475-479

Chronic Phase
If “first,” also complete question
479.
If “second or greater,” complete
questions 478-479.
Accelerated Phase
If yes, also complete questions
478-479.

Definition
A treatment response where all of the following
criteria are met:
White blood count is < 10 x 109/L, without
immature granulocytes and with < 5%
basophils
Platelet count < 450 x 109/L
Non-palpable spleen
Characterized by relatively few blasts (<10%)
present in the blood and bone marrow. Symptoms
are often not present. The chronic phase may last
several months to years, depending on the recipient
and the treatment they receive.
One or more of the following must be present:
10%-19% blasts in blood or marrow
≥ 20% basophils in peripheral blood
Clonal marrow cytogenetic abnormalities in
addition to the single Philadelphia
chromosome (clonal evolution)
Increasing spleen size, unresponsive to
therapy
Increasing WBC, unresponsive to therapy
Thrombocytopenia (platelets < 100,000),
unrelated to therapy
Thrombocytosis (platelets > 1,000,000),
unresponsive to therapy

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Table 11. Disease Status of CML (cont.)
Disease Response: Phase
Blast Crisis
If yes, also complete questions
478-479.

Definition
Characterized by having ≥ 20% blasts (formerly
≥ 30%) in the peripheral blood or bone marrow.
Having extramedullary blastic infiltrates (i.e., myeloid
sarcoma, granulocytic sarcoma, or chloroma) also
qualifies as blast phase. The red cell, platelet, and
neutrophil counts may decrease and episodes of
infection and bleeding may result. Symptoms such
as fatigue, shortness of breath, abdominal pain,
bone pain, and spleen enlargement may occur. Blast
crisis is similar to acute leukemia in its signs and its
effects on the recipient, and can involve lymphoid or
myeloid lineages (so-called lymphoid blast crisis or
myeloid blast crisis).

Question 475: Cytogenetic complete remission (Ph negative)
Cytogenetic response is determined by either conventional or FISH cytogenetics for the
Philadelphia chromosome [t(9;22)].
Cytogenetic responses are divided into several categories:
Complete: Ph+
0%
Partial:
Ph+
1%-35%
Minor:
Ph+ 36%-65%
Minimal:
Ph+ 66%-95%
None:
Ph+
> 95%
If the recipient had a complete cytogenetic response at the last evaluation prior to the
start of the preparative regimen, indicate “yes.”
If the recipient had a partial, minor, minimal, or none cytogenetic response at the last
evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No cytogenetic assessments were performed at any time prior to the start of the
preparative regimen.
The Philadelphia chromosome associated with the recipient’s disease was
identified previously and no cytogenetic assessment was performed prior to the
start of the preparative regimen.
The Philadelphia chromosome associated with the recipient’s disease was not
identified by previous testing and no cytogenetic abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
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Question 476: Molecular complete remission (BCR-ABL negative)
PCR testing reveals no molecular evidence of the BCR-ABL fusion gene in the blood
(e.g., BCR-ABL transcript is non-detectable and non-quantifiable in an assay that has at
least 4-5 log range of detection).
Molecular remission is a treatment response in which no minimal residual disease in the
blood and/or marrow can be detected by molecular methods (e.g., PCR).
If the BCR-ABL fusion gene associated with the recipient’s disease was identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If the BCR-ABL fusion gene associated with the recipient’s disease was identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No molecular assessments for the BCR-ABL fusion gene were performed at any
time prior to the start of the preparative regimen.
The BCR-ABL fusion gene associated with the recipient’s disease was identified
previously, but no molecular assessment was performed prior to the start of the
preparative regimen
The BCR-ABL fusion gene associated with the recipient’s disease was not
identified by previous testing and the BCR-ABL fusion gene was not identified at
the last evaluation prior to the start of the preparative regimen.
Question 477: CML disease status before treatment that achieved this CR
From the options listed below, indicate the disease status of CML immediately prior to
the treatment that achieved this complete hematologic remission.
Chronic Phase: Characterized by relatively few blasts (< 10%) present in the
blood and bone marrow. Symptoms are often not present. The chronic phase
may last several months to years depending on the individual recipient and the
treatment received.
Accelerated Phase: One or more of the following must be present (WHO
definition):
10%-19% blasts in blood or marrow
≥ 20% basophils in peripheral blood
Clonal cytogenetic abnormalities in addition to the single Philadelphia
chromosome (clonal evolution)
Increasing spleen size, unresponsive to therapy
Increasing WBC, unresponsive to therapy
Thrombocytopenia (platelets < 100,000) unrelated to therapy
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Thrombocytosis (platelets > 1,000,000) unresponsive to therapy
Blast Phase: Characterized by ≥ 20% blasts (formerly ≥ 30%) in the peripheral
blood or bone marrow. Having extramedullary blastic infiltrates (i.e., myeloid
sarcoma, granulocytic sarcoma, or chloroma) also qualifies as blast phase. The
red cell, platelet, and neutrophil counts may decrease, and episodes of infection
and bleeding may result. Symptoms such as fatigue, shortness of breath,
abdominal pain, bone pain, and spleen enlargement may occur. Blast crisis is
similar to acute leukemia in its signs and its effects on the recipient, and can
involve lymphoid or myeloid lineages (so-called lymphoid blast crisis or myeloid
blast crisis).
Question 478: Number
Indicate the number of the disease phase reported in question 474.
Question 465: Date assessed
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. The date reported should be that of the most disease-specific
assessment within the pre-transplant work-up period (approximately 30 days). Clinical
and hematologic assessments include pathological evaluation (e.g., bone marrow
biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and
laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician
evaluation and physical examination. Enter the date the sample was collected for
pathological and laboratory evaluations; enter the date the imaging took place for
radiographic assessments.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Myelodysplastic (MDS)/Myeloproliferative (MPN) Diseases
NOTE: MDS
If the recipient is being transplanted for AML that has transformed from MDS, the
primary disease for HCT must be reported as AML. Disease Classification questions
must be completed for both AML and MDS.
The myelodysplastic syndromes (MDS) are a group of clonal hematopoietic stem cell
diseases characterized by cytopenia(s), dysplasia (abnormal growth or development
leading to an alteration in size, shape, and organization of the cell) in one or more of the
major myeloid cell lines (WBC, RBC, and/or platelets), ineffective hematopoiesis, and
an increased risk of developing acute myelogenous leukemia (AML). MDS occurs
primarily in older adults, with a median age of 70 years. The majority of patients present
with symptoms related to cytopenias. Most patients present with anemia requiring RBC
transfusions.
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Primary or de novo MDS occurs without a known history of chemotherapy or radiation
exposure. Some inherited hematologic disorders, such as Fanconi anemia, dyskeratosis
congenita, Shwachmann-Diamond syndrome, and Diamond-Blackfan syndrome are
associated with an increased risk of MDS.
Myeloproliferative Neoplasms (MPN) are characterized by the overproduction of
blood cells (red blood cells, white blood cells, and/or platelets) or collagen in the bone
marrow. Often the MPN will be identified because of a blood test for another condition,
as some patients are asymptomatic. Common symptoms found in the array of
myeloproliferative disorders include fatigue and the enlargement of the spleen
(splenomegaly).
Question 480: What was the MDS/MPN subtype?
Please indicate the MDS/MPN subtype at diagnosis. Refer to Table 8 for diagnostic
characteristics.
Table 12. Hematologic disorders and characteristics
Disease

Diagnostic Characteristics

Myelodysplastic Syndromes (MDS)
Refractory cytopenia with unilineage
Includes refractory anemia (RA),
dysplasia (RCUD)
refractory neutropenia (RN), and
refractory thrombocytopenia (RT)
Unilineage dysplasia in ≥ 10% affected
lineage
Of erythroid precursors, < 15% are
ringed sideroblasts
Myeloblasts are not increased (< 5%)
Unicytopenia or bicytopenia of peripheral
blood with < 1% blasts
Refractory anemia with ringed sideroblasts
Unilineage, erythroid dysplasia in ≥ 10%
(RARS)
of red blood cell precursors
Ringed sideroblasts comprise ≥ 15%
nucleated erythroid precursors
Myeloblasts are not increased (< 5%)
Peripheral blood anemia with no blasts
Refractory anemia with excess blasts
5-9% blasts in the bone marrow and
(RAEB-1)
< 5% blasts in the peripheral blood
If < 5% blasts in the bone marrow, then
2-4% blasts in the peripheral blood
Unilineage or multilineage dysplasia
Absence of Auer rods
Multiple peripheral blood cytopenias
Peripheral blood with < 1 x 109/L
monocytes
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Table 12. Hematologic disorders and characteristics (cont.)
Disease

Diagnostic Characteristics
Myelodysplastic Syndromes (MDS) (cont.)
Refractory anemia with excess blasts
10-19% blasts in the bone marrow or 5(RAEB-2)
19% blasts in the peripheral blood
Unilineage or multilineage dysplasia
Auer rods may be present
Multiple peripheral blood cytopenias
Peripheral blood with < 1 x 109/L
monocytes
Refractory cytopenia with multilineage
One or more blood cytopenias with
dysplasia (RCMD)
dysplasia in two or more lines
Multilineage dysplasia in ≥ 10%
precursors
Absence of Auer rods
Blasts are not increased (< 5% marrow,
< 1% peripheral blood)
Multiple peripheral blood cytopenias
Peripheral blood with < 1 x 109/L
monocytes
Childhood myelodysplastic syndrome, aka
Multilineage dysplasia in ≥ 10% of
Refractory cytopenia of childhood (RCC)
precursors
Blasts are not increased (< 5% marrow,
< 2% peripheral blood)
Dysplastic changes in ≥ 10% of
neutrophils on peripheral blood smear
Myelodysplastic syndrome with isolated
Peripheral blood anemia
del(5q), (5q-syndrome)
Frequently hypolobated small
megakaryocytes
Blasts are not increased (< 5% blasts in
marrow, < 1% blasts in peripheral blood)
Deletion of part of the long arm of
chromosome 5, del(5q)
Must not meet criteria of any other
specific category
Myelodysplastic syndrome, unclassifiable
MDS that cannot be classified into any
(MDS-U)
other defined category due to one or
more atypical features
Examples include:
Hypocellular MDS
MDS with myelofibrosis
< 5% blasts in the marrow with Auer rods
present
MDS with unilineage dysplasia with
associated pancytopenia
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Table 12. Hematologic disorders and characteristics (cont.)
Disease

Diagnostic Characteristics

Myeloproliferative Neoplasms (MPN)
Chronic neutrophilic leukemia
Peripheral blood leukocytosis,
≥ 25 x 109/L with segmented neutrophils
> 80% and immature granulocytes < 10%
Blasts are not increased (< 5% marrow,
< 1% peripheral blood)
Normal granulocytic maturation
No Ph+ or BCR-ABL fusion and no
abnormalities of PDGFRA, PDGFRB, or
FGFR1
Reactive neutrophilia, PV, PMF, ET,
MDS, and MDS/MPN must be ruled out
Chronic eosinophilic leukemia, NOS
Peripheral blood eosinophilia
≥ 1.5 x 109/L
Evidence of clonal abnormality but must
not be Ph+ or BCR-ABL fusion;
rearrangement of PDGFRA, PDGFRB, or
FGFR1; or inversion or translocation of
(16)(p13.1,q22)
or
3-19% blasts in the peripheral blood or 619% blasts in the bone marrow.
Reactive and secondary eosinophilia
must be ruled out
Essential thrombocythemia
Includes primary thrombocytosis,
idiopathic thrombocytosis, and
hemorrhagic thrombocythemia
Bone marrow with megakaryocytic
hyperplasia; may have minimal fibrosis.
Typically no erythroid or granulocytic
hyperplasia. No ringed sideroblasts or
increased blasts.
JAK2 mutation or other clonal marker
Peripheral blood thrombocytosis,
≥ 450 x 109/L
CML, PMF, PV, MDS, and other myeloid
neoplasms must be ruled out
Polycythemia vera (PCV)
Presence of two major and one minor
criterion, or presence of one major and
two minor criterion
Major
Increased hemoglobin (> 18.5 g/dL in
men, > 16.5 g/dL in women)
JAK2 mutation
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Table 12. Hematologic disorders and characteristics (cont.)
Disease

Diagnostic Characteristics

Myeloproliferative Neoplasms (MPN) (cont.)
Minor
Polycythemia vera (PCV)
Low serum erythropoietin (EPO)
(cont.)
Hypercellular bone marrow with
panmyelosis
In vitro endogenous erythroid colony
formation
Primary myelofibrosis
Includes chronic idiopathic myelofibrosis
(CIMF), agnogenic* myeloid metaplasia
(AMM), myelofibrosis/sclerosis with
myeloid metaplasia (MMM), and
idiopathic myelofibrosis
Megakaryocytic hyperplasia with fibrosis
(MF 2-3) or hypercellular marrow with
granulocytic hyperplasia
JAK2 mutation or other clonal marker
PV, CML, MDS, and other myeloid
neoplasms must be ruled out
At least two of the following:
splenomegaly, anemia, increased serum
LDH, and leukoerythroblastosis
Myeloproliferative neoplasm (MPN),
Definite clinical, laboratory, and
unclassifiable
morphological features that fail to meet
criteria for specific MPN classification, or
overlap two or more MPN categories
No Ph+ or BCR-ABL fusion, and no
abnormalities of PDGFRA, PDGFRB, or
FGFR1
MPN, unclassifiable, should not be used
when clinical data is insufficient or not
available for proper classification of
disease
Myelodysplastic/Myeloproliferative Neoplasms
Chronic myelomonocytic leukemia
(CMMoL)

Blasts and promonocytes < 20% in
peripheral blood and bone marrow
Peripheral blood monocytosis,
> 1 x 109/L
Dysplasia in one or more lines; typically
seen, but not an absolute requirement for
diagnosis
No Ph+ or BCR-ABL fusion, and no
abnormalities of PDGFRA or PDGFRB

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Table 12. Hematologic disorders and characteristics (cont.)
Disease

Diagnostic Characteristics
Myelodysplastic/Myeloproliferative Neoplasms (cont.)

Myelodysplastic/myeloproliferative
neoplasm, unclassifiable

Clinical, laboratory, and morphological
features that overlap MPN and MDS; this
includes blasts < 20% in peripheral blood
and bone marrow, platelet count
≥ 450 x 109/L, and WBC ≥ 13 x 109/L
No Ph+ or BCR-ABL fusion, and no
abnormalities of PDGFRA, PDGFRB, or
FGFR1
MDS/MPN, unclassifiable, should not be
used for patient with a previous, welldefined MPN who develop dysplastic
features consistent with transformation to
a more aggressive histology
Atypical CML

Atypical chronic myeloid leukemia
Ph- & BCR-ABLPh- & BCR-ABL unknown
Ph unknown & BCR-ABLPh unknown & BCR-ABL unknown
If the recipient has atypical CML, continue
with question 577.

WBC ≥ 13 x 109/L
No Ph chromosome or BCR-ABL fusion
gene
No rearrangement of PDGFRA or
PDGFRB
Neutrophil precursors (promyelocytes,
myelocytes, metamyeloctes) ≥ 10% of
leukocytes
Basophils < 2%
Monocytes < 10%
< 20% blasts in blood and bone marrow
Hypercellular bone marrow with
granulocytic proliferation and dysplasia,
with or without dysplasia in the erythroid
and megakaryocytic lineages

*There is a typo on the form; the form should read “agnogenic” rather than angiogenic.
World Health Organization. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 2008, 4th ed. Lyon, France.

If the MDS/MPN subtype at diagnosis was “atypical chronic myeloid leukemia,” continue
with question 577.
Question 481: Was the disease (MDS/MPN) therapy-related?
Agents such as radiation or systemic therapy used to treat other diseases (e.g.,
Hodgkin lymphoma, non-Hodgkin lymphoma, or breast cancer) can damage the marrow
and lead to a secondary malignancy, such as MDS/MPN. If the diagnosis of MDS/MPN
is therapy-related, select “yes.” If the diagnosis of MDS/MPN is not therapy-related,
select “no.” If it is unknown if the MDS/MPN is therapy-related, select “unknown.”
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Do not answer this question “yes” if the recipient developed MDS/MPN after an
environmental exposure (e.g., exposure to benzene).
Question 482: Did the recipient have a predisposing condition?
A predisposing condition is a condition that contributes to the susceptibility of
developing MDS/MPN. If the recipient has a documented history of a predisposing
condition, select “yes” and continue with question 483. If there is no history of a
predisposing condition or if predisposition is unknown, indicate “no” or “unknown” and
continue with question 485.
Questions 483-484: Specify condition:
Aplastic anemia may progress to MDS and/or AML. Aplastic anemia is a broad
classification referring to bone marrow failure characterized by pancytopenia and
marrow hypoplasia.
Bloom syndrome is an autosomal recessive genetic disorder characterized by excessive
chromosome breakage, with corresponding rearrangements. It is characterized by
proportional dwarfism and sun sensitivity. The chromosomal instability seen in Bloom
syndrome is generally assumed to be responsible for these individuals’ predisposition to
malignancy.
Down syndrome is also a chromosomal disorder. It is characterized by an additional
chromosome 21, also referred to as trisomy 21. Down syndrome patients exhibit a
particular set of facial characteristics, growth deficiency, and cognitive impairment.
Although Down syndrome patients have a reduced risk of developing many common
malignancies, they have an increased risk of developing leukemia.
Fanconi anemia is a rare genetic blood disorder that prevents the body from producing
a sufficient number of new blood cells to function properly. Abnormal blood cells may
also be produced. These patients are short in stature, exhibit skeletal anomalies, and
have an increased risk of developing solid tumors and leukemias.
If the recipient had a predisposing condition not listed above, select “other condition”
and specify the condition in question 484.
Questions 485-486: WBC
Indicate whether the white blood cell (WBC) count was “known” or “unknown” at
diagnosis. If “known,” report the laboratory count and unit of measure documented on
the laboratory report in question 486. If “unknown,” continue with question 487.
Questions 487-488: Hemoglobin
Indicate whether the hemoglobin was “known” or “unknown” at diagnosis. If “known,”
report the laboratory count and unit of measure documented on the laboratory report in
question 488. If “unknown,” continue with question 490.

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Question 489: Was RBC transfused < 30 days before the date of test?
Transfusions temporarily increase the red blood cell count. It is important to distinguish
between a recipient whose body is creating these cells and a recipient who requires
transfusions to support the counts.
Indicate if red blood cells were transfused less than 30 days prior to the testing reported
in question 488.
Questions 490-491: Platelets
Indicate whether the platelet count was “known” or “unknown” at diagnosis. If “known,”
report the laboratory count and unit of measure documented on the laboratory report in
question 491. If “unknown,” continue with question 493.
Question 492: Were platelets transfused < 7 days before date of test?
Transfusions temporarily increase the platelet count. It is important to distinguish
between a recipient whose body is creating the platelets and a recipient who requires
transfusions to support the counts.
Indicate if platelets were transfused less than 7 days prior to the testing reported in
question 491.
Questions 493-494: Neutrophils
Indicate whether the neutrophil percentage in the blood was “known” or “unknown” at
diagnosis. If “known,” report the value documented on the laboratory report in question
494. If “unknown,” continue with question 495.
Questions 495-496: Blasts in bone marrow
NOTE:
If the bone marrow pathology report states a range for blasts, enter the average of the
range rounded to the nearest whole number (e.g., if 0-5%, enter 3%).
If the report indicates “sheets of blasts” or “packed marrow,” report 100%.
If the report states > n% blasts, enter (n +1)% on the form. For example, if the
laboratory report indicates > 90% blasts, report 91%.
If the report states < n% blasts, enter (n -1)% on the form. For example, if the laboratory
report indicates < 5% blasts, report 4%.
Indicate whether the percentage of blasts in the bone marrow was “known” or
“unknown” at diagnosis. If “known,” report the percentage documented on the laboratory
report in question 496. If “unknown,” continue with question 497.

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Question 497: Were cytogenetics tested (conventional or FISH)?
Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing
blood or bone marrow for the presence of a known chromosomal abnormality that
reflects the recipient’s disease. Testing methods you may see include conventional
chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For
more information about cytogenetic testing and terminology, see Appendix R,
Cytogenetic Abbreviations and Terminology.
Indicate if cytogenetic studies were obtained at diagnosis. If cytogenetic studies were
obtained, select “yes” and continue with question 498.
If no cytogenetic studies were obtained or it is unknown if chromosome studies were
performed, select “no” or “unknown” and continue with question 525.
Question 498: Results of test:
If cytogenetic studies identified abnormalities, indicate “abnormalities identified” and
continue with question 499.
If cytogenetic studies yielded “no evaluable metaphases” or there were “no
abnormalities” identified, continue with question 525.
Question 499: Specify the number of distinct cytogenetic abnormalities:
Indicate the total number of abnormalities at diagnosis.
Questions 500-524: Specify abnormalities identified at diagnosis:
Report all abnormalities identified by all methods of cytogenetic assessment at
diagnosis by selecting “yes” or “no” for each question. Do not leave any response blank.
If one or more abnormalities are best classified as “other abnormality,” select “yes” for
question 523 and specify the abnormality in question 524.
Question 525: Did the recipient progress or transform to a different MDS/MPN
subtype between diagnosis and the start of the preparative regimen?
Indicate if the recipient’s disease progressed to AML or transformed into a different
MDS/MPN subtype between initial diagnosis and the start of the preparative regimen.
Approximately one third of MDS cases transform into AML, signifying a poorer
prognosis. Progression to AML is defined by an increase in bone marrow blasts equal to
or greater than 20%.
MDS/MPN subtypes may also transform from one into another. For example RAEB-1
may transform into RAEB-2.
Indicate if the recipient’s disease progressed to AML or transformed from one
MDS/MPN subtype to another. If the recipient’s disease did transform or progress,
select “yes” and continue with question 526. If there was no documented transformation
or progression, select “no” and continue with question 528.
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If there was no documented transformation or progression and the disease subtype is
JMML, continue to the signature line.
Question 526: Specify the date of the most recent transformation:
Report the date of assessment that determined the most recent disease transformation
(i.e., if there were multiple transformations, report the most recent). Report the date of
the pathological evaluation (e.g., bone marrow) or blood/serum assessment (e.g., CBC,
peripheral blood smear). Enter the date the sample was collected for pathological and
laboratory evaluations.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.
Question 527: Specify the MDS/MPN subtype after transformation:
Indicate the recipient’s current MDS/MPN subtype after transformation. If the recipient
experienced more than one transformation after diagnosis, report the most recent
subtype. For MDS/MPN subtype characteristics, see Table 12 above. Unless the
recipient transformed to AML, continue with question 528.
If the disease transformed to AML, continue to the signature line.
Questions 528-529: WBC
Indicate whether the white blood cell (WBC) count was “known” or “unknown” at the last
evaluation prior to the start of the preparative regimen. If “known,” report the laboratory
count and unit of measure documented on the laboratory report in question 529. If
“unknown,” continue with question 530.
Questions 530-531: Hemoglobin
Indicate whether the hemoglobin was “known” or “unknown” at the last evaluation prior
to the start of the preparative regimen. If “known,” report the laboratory count and unit of
measure documented on the laboratory report in question 53. If “unknown,” continue
with question 533.
Question 532: Was RBC transfused < 30 days before the date of test?
Transfusions temporarily increase the red blood cell count. It is important to distinguish
between a recipient whose body is creating these cells and a recipient who requires
transfusions to support the counts.
Indicate if red blood cells were transfused less than 30 days prior to the testing reported
in question 531.
Questions 533-534: Platelets
Indicate whether the platelet count was “known” or “unknown” at the last evaluation prior
to the start of the preparative regimen. If “known,” report the laboratory count and unit of
measure documented on the laboratory report in question 534. If “unknown,” continue
with question 536.
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Question 535: Were platelets transfused < 7 days before date of test?
Transfusions temporarily increase the platelet count. It is important to distinguish
between a recipient whose body is creating the platelets and a recipient who requires
transfusions to support the counts.
Indicate if platelets were transfused less than 7 days prior to the testing reported in
question 534.
Questions 536-537: Neutrophils
Indicate whether the neutrophil percentage in the blood was “known” or “unknown” at
the last evaluation prior to the start of the preparative regimen. If “known,” report the
value documented on the laboratory report in question 537. If “unknown,” continue with
question 538.
Questions 538-537: Blasts in bone marrow:
NOTE:
If the bone marrow pathology report states a range for blasts, enter the average of the
range rounded to the nearest whole number (e.g., if 0-5%, enter 3%).
If the report indicates “sheets of blasts” or “packed marrow,” report 100%.
If the report states > n% blasts, enter (n+1)% on the form. For example, if the laboratory
report indicates > 90% blasts, report 91%.
If the report states < n% blasts, enter (n-1)% on the form. For example, if the laboratory
report indicates < 5% blasts, report 4%.
Indicate whether the percentage of blasts in the bone marrow was “known” or
“unknown” at the last evaluation prior to the start of the preparative regimen. If “known,”
report the percentage documented on the laboratory report in question 539. If
“unknown,” continue with question 540.
Question 540: Were cytogenetics tested (conventional or FISH)?
Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing
blood or bone marrow for the presence of a known chromosomal abnormality that
reflects the recipient’s disease. Testing methods you may see include conventional
chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For
more information about cytogenetic testing and terminology, see Appendix R,
Cytogenetic Abbreviations and Terminology.
Indicate if cytogenetic studies were obtained at the last evaluation prior to the start of
the preparative regimen. If cytogenetic studies were obtained, select “yes” and continue
with question 541.
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If no cytogenetic studies were obtained or it is unknown if chromosome studies were
performed, select “no” or “unknown” and continue with question 568.
Question 541: Results of test:
If cytogenetic studies identified abnormalities, indicate “abnormalities identified” and
continue with question 542.
If cytogenetic studies yielded “no evaluable metaphases” or there were “no
abnormalities” identified, continue with question 568.
Question 542: Specify the number of distinct cytogenetic abnormalities:
Indicate the total number of abnormalities at the last evaluation prior to the start of the
preparative regimen.
Questions 543-567: Specify abnormalities identified at the last evaluation prior to
the start of the preparative regimen:
Report all abnormalities identified by all methods of cytogenetic assessment at the last
evaluation prior to the start of the preparative regimen by selecting “yes” or “no” for each
question. Do not leave any response blank. If one or more abnormalities are best
classified as “other abnormality” select “yes” for question 566 and specify the
abnormality in question 567.
Question 568: What was the disease status?
Indicate the disease status of MDS/MPN at the last evaluation prior the start of the
preparative regimen.
Table 13. Disease Status of MDS/MPN
Disease Status
Complete Remission (CR)
If yes, continue with question
572.

Description
Requires all of the following, maintained for ≥ 4 weeks:
Bone marrow evaluation:
< 5% myeloblasts, with normal maturation of all cell
lines.
Peripheral blood evaluation:
Hemoglobin ≥ 11 g/dL untransfused without
erythropoietic support
ANC ≥ 1000/mm3 without myeloid growth factor
support
Platelets ≥ 100,000/mm3 without thrombopoietic
support
0% blasts in blood

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Table 13. Disease Status of MDS/MPN (cont.)
Disease Status
Complete Remission (CR)
(cont.)

Hematologic Improvement
(HI)
If yes, continue with question
569.

Description
Alternative CR criteria are accepted in the setting of
pediatric MDS and are as follows:
Complete donor chimerism (≥ 95% donor chimerism
without recipient cells detected)
Hemoglobin ≥ 11 g/dL untransfused without
erythropoietic support
ANC ≥ 1000/mm3 without myeloid growth factor
support
Platelets ≥ 100,000/mm3 without thrombopoietic support
Requires one measurement of the following, maintained
for ≥ 8 weeks without ongoing cytotoxic therapy:
Hematologic Improvement - Erythropoietic (HI-E):
Hemoglobin increase of ≥ 1.5 g/dL untransfused, or
For RBC transfusions performed for hemoglobin ≤ 9.0,
reduction in RBC units transfused in 8 weeks by ≥ 4
units compared to the pre-treatment transfusion
number in previous 8 weeks.
Hematologic Improvement - Platelets (HI-P):
For pre-transplant platelet count of > 20 x 109, platelet
absolute increase of ≥ 30 x 109
For pre-transplant platelet count of < 20 x 109, platelet
absolute increase of ≥ 20 x 109 and ≥ 100% increase
from pre-treatment level

No Response (NR)/Stable
Disease (SD)
If yes, continue with question
572.
Progression from
Hematologic Improvement
(Prog from HI)
If yes, continue with question
570.

Hematologic Improvement - Neutrophils (HI-N):
Neutrophil count increase of ≥ 100% from pretreatment level and an absolute increase of
≥ 500/mm3
Does not meet the criteria for at least HI, but no
evidence of disease progression

Requires at least one of the following, in the absence of
another explanation (e.g., infection, bleeding, ongoing
chemotherapy, etc.):
≥ 50% reduction from maximum response levels in
granulocytes or platelets
Reduction in hemoglobin by ≥ 1.5 g/dL
Transfusion dependence
Note: declining donor chimerism does not meet the
criteria for progression.

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Table 13. Disease Status of MDS/MPN (cont.)
Disease Status
Relapse from Complete
Response (Rel from CR)
If yes, continue with question
571.

Not Assessed
If yes, continue with
signature line.

Description
Requires at least one of the following:
Return to pre-treatment bone marrow blast
percentage
Decrease of ≥ 50% from maximum response levels in
granulocytes or platelets
Transfusion dependence, or hemoglobin level ≥ 1.5
g/dL lower than prior to therapy
Note: declining donor chimerism does not meet the
criteria for relapse.
No evaluation performed

Question 569: Specify the cell line examined to determine HI status:
Indicate the cell line examined to determine hematologic improvement. To determine
the cell line, review the Hematologic Improvement criteria listed above. Continue with
question 572.
Question 570: Date of progression
Enter the assessment date that progression from hematologic improvement was
established prior to the start of the preparative regimen. Report the date of the
pathological evaluation (e.g., bone marrow) or blood/serum assessment (e.g., CBC,
peripheral blood smear). Enter the date the sample was collected for pathological and
laboratory evaluations. If extramedullary disease was detected upon radiographic
examination (e.g., X-ray, CT scan, MRI scan, PET scan), enter the date the imaging
took place.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.
Question 571: Date of relapse:
Enter the assessment date that relapse from complete remission was established prior
to the start of the preparative regimen. Report the date of the pathological evaluation
(e.g., bone marrow) or blood/serum assessment (e.g., CBC, peripheral blood smear).
Enter the date the sample was collected for pathological and laboratory evaluations. If
extramedullary disease was detected on radiographic examination (e.g., X-ray, CT
scan, MRI scan, PET scan), enter the date the imaging took place.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

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Question 572: Date assessed:
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. The date reported should be that of the most disease-specific
assessment within the pre-transplant work-up period (approximately 30 days). Clinical
and hematologic assessments include pathological evaluation (e.g., bone marrow
biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and
laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician
evaluation and physical examination. Enter the date the sample was collected for
pathological and laboratory evaluations; enter the date the imaging took place for
radiographic assessments.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Other Leukemia (OL)
CLL, or chronic lymphocytic leukemia, is characterized by ≥ 5 x 109/L monoclonal
lymphocytes with a CLL phenotype (usually co-expressed CD5 and CD23). The term
SLL, or small lymphocytic lymphoma is used for non-leukemic cases with the tissue
morphology and immunophenotype of CLL.
Hairy cell leukemia is characterized by the presence of abnormal B-lymphocytes in the
bone marrow, peripheral blood, and spleen.
PLL, or prolymphocytic leukemia, is a type of CLL and is characterized by increased
presence of immature prolymphocytes in the bone marrow and peripheral blood.
Questions 573-574: Specify the other leukemia classification
Indicate the other leukemia disease classification at diagnosis. If the subtype is not
listed, report as “other leukemia” and specify the reported disease.
Question 575: Was any 17p abnormality detected?
Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing
blood or bone marrow for the presence of a known chromosomal abnormality that
reflects the recipient’s disease. Testing methods you may see include conventional
chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For
more information about cytogenetic testing and terminology, see Appendix R,
Cytogenetic Abbreviations and Terminology.
Indicate if cytogenetic studies detected any 17p abnormality at any time prior to the start
of the preparative regimen.
If “yes” and the disease classification is CLL, continue with question 576. If “yes” and
the disease classification is PLL, continue with question 578.
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If cytogenetic studies did not detect any 17p abnormality at any time prior to the start of
the preparative regimen, select “no” and continue with question 576.
Question 576: Did a histologic transformation to diffuse large B-cell lymphoma
(Richter syndrome) occur at any time after CLL diagnosis?
Histologic transformation may occur after CLL diagnosis. Indicate if CLL transformed
into diffuse large B-cell lymphoma (known as Richter’s transformation or Richter’s
syndrome). If CLL transformed, select “yes” and continue with question 583. If CLL did
not transform, select “no” and continue with question 578.
Question 577: What was the disease status?
Indicate the disease status for atypical CML at the last evaluation prior the start of the
preparative regimen and continue with question 579.
Table 14. Disease Status of Atypical CML
Disease Status

Definition

Primary Induction
Failure (PIF)

The patient received treatment for atypical CML but never
achieved complete remission at any time. PIF is not limited
by the number of unsuccessful treatments; this disease status
only applies to recipients who have never been in complete
remission.
All of the following criteria are met and maintained for four or
more weeks:

Complete Remission
(CR)

Marrow with normal maturation of all cellular components
≤ 5% blasts in the marrow
No signs or symptoms of the disease
If the timeframe between achieving CR and the start date of the
HCT (i.e., day 0) is less than four weeks, and the recipient is
believed to be in CR, report the status at transplantation as CR.
Important: if within four weeks following transplant the
recipient’s status is determined to not be CR, an Error
Correction Form must be submitted to change the pre-HCT
status.
Include recipients with persistent cytogenetic abnormalities who
otherwise meet all the criteria of CR.
Report that the recipient is in CR at the time of transplant no
matter how many courses of therapy it may have taken to
achieve that CR.
The number of this complete remission can be determined by
using the following guidelines:
1st CR: no prior relapse
2nd CR: one prior relapse
3rd or higher: two or more prior relapses
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Table 14. Disease Status of CML (cont.)
Disease Status

Definition

Relapse (REL)

Recurrence of disease after CR. Relapse is defined as:
> 5% blasts in the marrow
Extramedullary disease
Reappearance of cytogenetic abnormalities and/or
molecular markers associated with the diagnosis at levels
that, as determined by a physician, represent relapse.
The number of this relapse can be determined by using the
following guidelines:
1st relapse: one prior CR
2nd relapse: two prior CRs
3rd or higher: three or more CRs
The recipient was diagnosed with atypical CML and never
treated.

No treatment

Question 578: What was the disease status?
Indicate the disease status for CLL/SLL, PLL, or hairy cell leukemia at the last
evaluation prior the start of the preparative regimen and continue with question 579.
Use the following disease status definitions if the disease classification is reported as
CLL or PLL:
Table 15. Disease Status of CLL/SLL, PLL
Disease Status

Definition

Never Treated

The recipient was diagnosed with CLL/SLL or PLL and never
treated.
Requires all the following:

Complete Remission
(CR)

Nodular Partial
Remission (nPR)

No radiographic evidence of lymphadenopathy
No organomegaly
Neutrophils > 1.5 x 109/L
Platelets > 100 x 109/L
Hemoglobin > 11g/dL
Lymphocytes < 4 x 109/L
Bone marrow < 30% lymphocytes
Absence of constitutional symptoms (e.g., fatigue,
fevers, night sweats)
Complete response with persistent lymphoid nodules in bone
marrow.

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Table 15. Disease Status of CLL/SLL, PLL (cont.)
Disease Status

Definition

Partial Remission
(PR)

Requires all of the following:
≥ 50% decrease in peripheral blood lymphocyte count
from pre-treatment value
≥ 50% reduction in lymphadenopathy if present
pretreatment
≥ 50% reduction in liver and spleen size if enlarged
pretreatment
AND one or more of the following:

No Response/Stable
Disease (NR/SD)
Progression

Relapse (untreated)

Neutrophils ≥ 1.5 x 109/L or 50% above baseline
Platelets > 100 x 109/L or 50% improvement over
baseline
Hemoglobin > 11.0 g/dL or 50% improvement over
baseline
No change. Not complete response, partial response, or
progressive disease.
Requires one or more of the following:
≥ 50% increase in the sum of the products of ≥ 2 lymph
nodes (≥ 1 node must be ≥ 2 cm) or new nodes
≥ 50% increase in liver or spleen size, or new
hepatomegaly or splenomegaly
≥ 50% increase in absolute lymphocyte count to
≥ 5 x 109/L
Transformation to a more aggressive histology
The re-appearance of disease after complete recovery. Relapse
should be determined by one or more diagnostic tests.

Use the following disease status definitions if the disease classification is reported as
hairy cell leukemia:
Table 16. Disease Status of Hairy Cell Leukemia
Disease Status

Definition*

Never Treated

The recipient was diagnosed with hairy cell leukemia and never
treated.
Disappearance of all evidence of disease.

Complete Remission
(CR)

Requires all of the following:
Neutrophils ≥ 1.5 x 109
Hemoglobin ≥ 12.0 g/dL
Platelets ≥ 100 x 109/L
Absence of hairy cells on peripheral blood smear
No palpable lymphadenopathy or hepatosplenomegaly

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Table 16. Disease Status of Hairy Cell Leukemia (cont.)
Disease Status

Definition*

Nodular Partial
Remission (nPR)
Partial Remission
(PR)

Not applicable for hairy cell leukemia.

No Response/Stable
Disease (NR/SD)
Progression
Relapse (untreated)

Requires all of the following:
≥ 50% reduction in the absolute hairy cell count in the
peripheral blood and the bone marrow
≥ 50% improvement of all cytopenias
≥ 50% reduction in abnormal lymphadenopathy or
hepatosplenomegaly
Not applicable for hairy cell leukemia.
Not applicable for hairy cell leukemia.
Relapse after CR:
Reappearance of hairy cells in the peripheral blood smear
and/or bone marrow (regardless of the degree of
infiltration)
Development of peripheral blood cytopenias
Splenomegaly
Relapse after PR:
≥ 50% increase of residual hairy cells in the marrow
Development of cytopenias
Splenomegaly insufficient to qualify as PR
or
Reappearance of hairy cells in the bone marrow of those
patients who had been classified as partial responders
based on residual splenomegaly only

*Definitions from http://bloodjournal.hematologylibrary.org/cgi/content/full/92/6/1918
Accessibility verified on October 21, 2013

Other leukemia: To determine the disease status, use the criteria for the leukemia that
most closely resembles the disease for which this form is being completed. For
questions, contact your transplant center’s CIBMTR CRC.
Question 579: Date assessed:
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. The date reported should be that of the most disease-specific
assessment within the pre-transplant work-up period (approximately 30 days). Clinical
and hematologic assessments include pathological evaluation (e.g., bone marrow
biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and
laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician
evaluation and physical examination. Enter the date the sample was collected for
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pathological and laboratory evaluations; enter the date the imaging took place for
radiographic assessments.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Hodgkin Lymphoma
Hodgkin lymphoma (HL or Hodgkin disease) is a cancer of the immune system that
is marked by the presence of a type of cell called the Reed-Sternberg cell. The two
major types of Hodgkin lymphoma are classical Hodgkin lymphoma (90-95% of cases)
and nodular lymphocyte-predominant Hodgkin lymphoma (5-10% of cases).
Classical Hodgkin lymphoma can be further subdivided into four histologic subtypes:
nodular sclerosis (NS), mixed cellularity (MC), lymphocyte deplete (LD), and lymphocyte
rich (LR). Symptoms include the painless enlargement of lymph nodes, spleen, or other
immune tissue. Generalized pruritus is also common and may precede the diagnosis by
months. The most common sites of involvement include cervical, supraclavicular, and
mediastinal lymph nodes. Central nervous system involvement may occur in rare cases.
Other symptoms include fever, weight loss, fatigue, and/or night sweats.
Hodgkin Lymphoma (HL) and non-Hodgkin Lymphoma (NHL) are WHO disease
classification subtypes of lymphoma. HL and NHL can transform into other disease
subtypes. NHL can transform into other NHL subtypes, or into HL subtypes, but HL will
rarely transform into NHL. Additionally, HL and NHL can occur at the same time.
In order to complete the correct Disease Classification questions for a recipient who has
a history of both HL and NHL, it is important to determine which disease is active
prior to the start of the preparative regimen. A physician must make this
determination.
The following two scenarios are examples of the data reporting practice for recipients
with a combination of HL and NHL.
Scenario 1: A recipient is being transplanted for active NHL, but has a history of
HL that is in remission at the start of the preparative regimen. Report the active
NHL on the Disease Classification questions, and report HL as a prior
malignancy (questions 134-154).
Scenario 2: A recipient is being transplanted for both active NHL and active HL.
Report this as NHL using “Other B-cell Lymphoma” and specify in question 584.
Complete the Disease Classification questions for NHL.
Question 580: Specify Hodgkin lymphoma classification
Indicate the Hodgkin lymphoma disease classification at diagnosis.
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Question 581: What was the disease status?
Indicate the disease status at the last evaluation prior to the start of the preparative
regimen. When determining the disease status, compare the restaging assessments
immediately prior to the preparative regimen to the assessments at baseline. “Baseline”
is defined as the disease at diagnosis or at relapse/progression.
Table 17. Disease Status of Hodgkin Lymphoma
Disease Status

Definition

Disease Untreated

The recipient was diagnosed with lymphoma and never treated.

PIF/Partial
Remission (PR1)

Never in complete remission but with stable or progressive
disease upon treatment, or never in complete remission but with
partial remission upon treatment.
Partial remission is ≥ 50% reduction in greatest diameter of up to
six largest dominant nodes or nodal masses and no new sites. For
typically PET-avid lymphoma, post-treatment PET should be
positive in at least one site. For variably-PET avid lymphoma, use
CT criteria.
For patients with splenic or hepatic involvement, PR is a ≥ 50%
reduction in sum of the product of the diameters (SPD) of nodules
(for single nodule, in greatest transverse diameter) and no
increase in size of liver or spleen.
Sensitivity to Chemotherapy:
Sensitivity is measured based on the last chemotherapy given
within the six months prior to HCT. Indicate the recipient’s
sensitivity to chemotherapy using the following guidelines:
Sensitive: ≥ 50% reduction in the bi-dimensional
diameters of all disease sites with no new sites of disease
(PIF sen, PR1)
Resistant: < 50% reduction in the diameter of all disease
sites or development of new disease sites (PIF res)
Unknown (PIF unk)

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Table 17. Disease Status of Hodgkin Lymphoma (cont.)
Disease Status

Definition

Complete
Remission (CR1,
CR2, CR3+)

Complete disappearance of all known disease. For typically PETavid lymphoma, a post-treatment residual mass of any size is
permitted as long as it is PET negative. For variably PET-avid
lymphoma, all lymph nodes and nodal masses must have
regressed, as measured by CT, to < 1.5 cm (for nodes > 1.5 cm
before therapy) or < 1 cm (for nodes 1.1 cm to 1.5cm before
therapy).
If the patient had splenic or hepatic involvement, the spleen and/or
liver should no longer be palpable and any nodules have
disappeared.
If the patient had evidence of bone marrow involvement, the
infiltrate must be cleared on repeat biopsy. If indeterminate by
morphology, immunohistochemistry should be negative.
CR1: first complete remission
CR2: 2nd complete remission following relapse
CR3: 3rd or more complete remission following relapses

Relapse (Rel)

Do not include PRs when calculating the number of CRs.
Recurrence of disease after CR.
1st relapse: one prior complete remission
2nd relapse: two prior complete remissions
3rd or higher: three or more complete remissions followed
by relapse.
Do not include PRs when calculating the number of relapses.
Sensitivity to Chemotherapy:
Sensitivity is measured based on the last chemotherapy given
within the six months prior to HCT. Indicate the recipient’s
sensitivity to chemotherapy using the following guidelines:
Sensitive: ≥ 50% reduction in the bi-dimensional
diameters of all disease sites with no new sites of
disease (REL sen)
Resistant: < 50% reduction in the diameter of all
disease sites or development of new disease sites (REL
res)
Untreated: No chemotherapy was given within the 6
months prior to the preparative regimen (REL unt)
Unknown (REL unk)

Question 582: Date assessed:
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. Report the date imaging took place for the radiographic
assessment (CT, MRI, PET, or PET/CT). Report the date the sample was collected for
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pathological evaluation (e.g., bone marrow biopsy). If no radiographic or pathologic
assessment was performed within one month prior to transplant, report the most recent
office visit in which the physician evaluated the recipient’s disease status.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Non-Hodgkin Lymphoma
NOTE: Waldenstrom Macroglobulinemia
On previous versions of the CIBMTR forms, Waldenstrom Macroglobulinemia was
classified as a Plasma Cell Disorder. Per the WHO disease classifications,
Waldenstrom Macroglobulinemia is now classified in the Non-Hodgkin Lymphoma
section.
Non-Hodgkin lymphoma (NHL) is a large group of cancers derived from lymphocytes
(white blood cells). Non-Hodgkin lymphomas can occur at any age and are often
marked by enlarged lymph nodes, fever, night sweats and weight loss. There are many
different types of non-Hodgkin lymphoma. These types can be divided into aggressive
(fast-growing), intermediate, or indolent (slow-growing) and can develop from either Bcells or T-cells. See Table 9.
Due to the aggressive nature of Precursor T- and Precursor B-cell lymphoblastic
lymphoma (or lymphoma/leukemia), the primary disease reported for recipients with
these malignancies should be acute lymphoblastic leukemia (T-cell lymphoblastic
leukemia/lymphoma or B-cell ALL, NOS {L1/L2}).
Lymphomas that occur after bone marrow or stem cell transplantation are usually B-cell
non-Hodgkin lymphomas and are collectively known as post-transplant
lymphoproliferative disorders (PTLD).
Table 18. Types of Non-Hodgkin Lymphomas
B-cell Neoplasms
B-cell lymphoma, unclassifiable, with features
intermediate between diffuse large B-cell
lymphoma (DLBCL) and Burkitt lymphoma
B-cell lymphoma, unclassifiable, with features
intermediate between DLBCL and Hodgkin
Lymphoma
Burkitt Lymphoma
Diffuse, large B-cell lymphoma (NOS)
Extranodal marginal zone B-cell lymphoma of
mucosa-associated lymphoid tissues (MALT)

T-cell and NK-cell Neoplasms
Adult T-cell lymphoma/leukemia (HTLV1
associated)
Aggressive NK-cell leukemia

Anaplastic large-cell lymphoma (ALCL), ALK
negative
Anaplastic large-cell lymphoma (ALCL), ALK
positive
Angioimmunoblastic T-cell lymphoma

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Table 18. Types of Non-Hodgkin Lymphomas (cont.)
B-cell Neoplasms
Follicular (grade unknown)
Follicular, predominantly small cleaved cell
(Grade I follicle center lymphoma)
Follicular, mixed, small cleaved and large cell
(Grade II follicle cell lymphoma)
Follicular, predominantly large cell (Grade IIIA
follicle cell lymphoma)
Follicular, predominantly large cell (grade IIIB
follicle cell lymphoma)
Intravascular large B-cell lymphoma

Mantle cell lymphoma
Nodal marginal zone B-cell lymphoma (±
monocytoid B-cells)
Primary diffuse, large B-cell lymphoma of the
CNS
Primary effusion lymphoma
Primary mediastinal (thymic) large B-cell
lymphoma
Splenic marginal zone B-cell lymphoma
T-cell/histiocyte-rich large B-cell lymphoma
Other B-cell lymphoma

T-cell and NK-cell Neoplasms
Enteropathy-type T-cell lymphoma
Extranodal NK/T-cell lymphoma, nasal type
Hepatosplenic T-cell lymphoma
Mycosis fungoides
Peripheral T-cell lymphoma (PTCL), NOS
Primary cutaneous CD30+ T-cell
lymphoproliferative disorders [Primary
cutaneous anaplastic large-cell lymphoma (CALCL), lymphoid papulosis]
Sezary syndrome
Subcutaneous panniculitis-like T-cell
lymphoma
T-cell large granular lymphocytic leukemia
Other T-cell/NK-cell lymphoma

Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) are WHO disease
classification subtypes of lymphoma. HL and NHL often transform into other disease
subtypes. NHL can transform into other NHL subtypes, or into HL subtypes, but HL will
rarely transform into NHL. Additionally, HL and NHL can occur at the same time.
In order to complete the correct Disease Classification questions for a recipient who has
a history of both HL and NHL, it is important to determine which disease is active
prior to the start of the preparative regimen.
The following two scenarios are examples of the data reporting practice for recipients
with a combination of HL and NHL.
Scenario 1: A recipient is being transplanted for active NHL, but has a history of
HL that is in remission at the start of the preparative regimen. Report the active
NHL on the Disease Classification questions, and report HL as a prior
malignancy (questions 134-154).

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Scenario 2: A recipient is being transplanted for both active NHL and active HL.
Report this as NHL using “Other B-cell Lymphoma” and specify in question 584,
completing the Disease Classification questions for NHL.
Questions 583-584: Specify Non-Hodgkin lymphoma classification
Indicate the non-Hodgkin lymphoma disease classification at diagnosis. If the subtype is
not listed, report as “other B-cell lymphoma” or “other T-cell/NK-cell lymphoma” and
specify the reported disease.
If non-Hodgkin lymphoma transforms from one subtype to another, report the most
current subtype. Report the initial diagnosis date of the first subtype in question 356.
Question 585: Is the non-Hodgkin lymphoma histology reported at diagnosis
(question 583) a transformation from CLL?
In some cases, CLL may evolve to a more aggressive diffuse large B-cell lymphoma
(DLBCL). This is commonly referred to as Richter’s syndrome or Richter’s
transformation.
If the current histology is a transformation from CLL, indicate “yes,” continue with
question 587. Also, complete the Disease Classification questions for CLL (questions
573-579).
If the current histology is not a transformation from CLL, indicate “no” and continue with
question 586.
Question 586: Is the non-Hodgkin histology reported (in question 583) a
transformation from, or was it diagnosed at the same time as another lymphoma
(not CLL)?
Transformation may occur when a slow-growing lymphoma with an indolent clinical
history changes to a more aggressive lymphoma histologically and clinically. An
example of a common transformation would include follicular lymphoma evolving to a
diffuse large B-cell lymphoma (DLBCL).
If a histologic transformation occurred after or concurrently with diagnosis, indicate
“yes.” If a histologic transformation did not occur, indicate “no.”
Question 587: What was the disease status?
Indicate the disease status at the last evaluation prior to the start of the preparative
regimen. When determining the disease status, compare the restaging assessments
immediately prior to the preparative regimen to the assessments at baseline. “Baseline”
is defined as the disease at diagnosis or at relapse/progression.

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Table 19. Disease Status of Non-Hodgkin Lymphoma
Disease Status
Disease Untreated

Definition
The recipient was diagnosed with lymphoma and never treated.

PIF/Partial
Remission (PR1)

Never in complete remission but with stable or progressive
disease upon treatment, or never in complete remission but with
partial remission upon treatment.
Partial remission is ≥ 50% reduction in greatest diameter of up to
six largest dominant nodes or nodal masses and no new sites. For
typically PET-avid lymphoma, post-treatment PET should be
positive in at least one site. For variably-PET avid lymphoma, use
CT criteria.
For patients with splenic or hepatic involvement, PR is a ≥ 50%
reduction in sum of the product of the diameters (SPD) of nodules
(for single nodule, in greatest transverse diameter) and no
increase in size of liver or spleen.
Sensitivity to Chemotherapy:
Sensitivity is measured based on the last chemotherapy given
within the six months prior to HCT. Indicate the recipient’s
sensitivity to chemotherapy using the following guidelines:

Complete
Remission (CR1,
CR2, CR3+)

Sensitive: ≥ 50% reduction in the bi-dimensional
diameters of all disease sites with no new sites of disease
(PIF sen, PR1)
Resistant: < 50% reduction in the diameter of all disease
sites or development of new disease sites (PIF res)
Unknown (PIF unk)
Complete disappearance of all known disease. For typically PETavid lymphoma, a post-treatment residual mass of any size is
permitted as long as it is PET negative. For variably PET-avid
lymphoma, all lymph nodes and nodal masses must have
regressed, as measured by CT, to < 1.5 cm (for nodes > 1.5 cm
before therapy) or < 1 cm (for nodes 1.1 cm to 1.5cm before
therapy).
If the patient had splenic or hepatic involvement, the spleen and/or
liver should no longer be palpable and any nodules disappeared.
If the patient had evidence of bone marrow involvement, the
infiltrate must be cleared on repeat biopsy. If indeterminate by
morphology, immunohistochemistry should be negative.
CR1: first complete remission
CR2: 2nd complete remission following relapse
CR3: 3rd or more complete remission following relapses
Do not include PRs when calculating the number of CRs.

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Table 19. Disease Status of Non-Hodgkin Lymphoma (cont.)
Disease Status
Relapse (Rel)

Definition
Recurrence of disease after CR.
1st relapse: one prior complete remission
2nd relapse: two prior complete remissions
3rd or higher: three or more complete remissions followed
by relapse.
Do not include PRs when calculating the number of relapses.
Sensitivity to Chemotherapy:
Sensitivity is measured based on the last chemotherapy given
within the six months prior to HCT. Indicate the recipient’s
sensitivity to chemotherapy using the following guidelines:
Sensitive: ≥ 50% reduction in the bi-dimensional
diameters of all disease sites with no new sites of
disease (REL sen)
Resistant: < 50% reduction in the diameter of all
disease sites or development of new disease sites (REL
res)
Untreated: No chemotherapy was given within the 6
months prior to the preparative regimen (REL unt)
Unknown (REL unk)

Question 588: Date assessed:
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. Report the date imaging took place for the radiographic
assessment (CT, MRI, PET, or PET/CT). Report the date the sample was collected for
pathological evaluation (e.g., bone marrow biopsy). If no radiographic or pathologic
assessment was performed within one month prior to transplant, report the most recent
office visit at which the physician evaluated the recipient’s disease status.
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Multiple Myeloma/Plasma Cell Disorder (PCD)
One kind of white blood cell, the plasma cell (also called plasma B cells, plasmocytes,
or effector B cells), produces proteins called antibodies or immunoglobulins (Igs) that
are part of our defense system against foreign substances (called antigens). Antibodies
are produced in response to such things as viruses, bacteria, and other infectious
agents.
Multiple myeloma is a cancer that leads to the proliferation of malignant plasma cells
(myeloma cells). Myeloma cells usually proliferate in the bone marrow. When myeloma
cells grow into isolated masses in other sites, these masses are called plasmacytomas.
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Health problems caused by multiple myeloma can affect the bones, immune system,
kidneys, and red blood cell count.
The immunoglobulins (antibodies) produced by healthy plasma cells are composed of
pairs of heavy chains and light chains (see Graphic 1 below). Healthy plasma cells
create many different kinds of immunoglobulins that are classified by their heavy chain
type into five categories (IgG, IgA, IgM, IgD, or IgE). The light chain types are
designated kappa (κ) or lambda (λ). The whole Ig molecule is then labeled IgG kappa,
IgG lambda, IgA kappa, IgA lambda, etc. These protein levels can be measured in
blood serum and/or urine.
Graphic 1: Structure of an Immunoglobulin (Antibody)

Secretory Multiple Myeloma:
Healthy plasma cells make immunoglobulins (antibodies) of all types. With the
proliferation of malignant plasma cells, the level of one immunoglobulin type increases
in the blood and/or urine. This abnormal immunoglobulin type is called the monoclonal
immunoglobulin, monoclonal protein (M-protein/M-spike/M-component), or paraprotein.
In most cases, the normal immunoglobulins are reciprocally depressed. Patients with
this condition are said to have secretory myeloma.
Some myeloma patients make only an excess of the light chain portion of the
immunoglobulin molecule (i.e., only monoclonal kappa or lambda light chains). The light
chain is also called Bence Jones protein. In most patients whose myeloma cells only
make light chains, this paraprotein may not be detectable in the blood, but only in the
urine. These patients are said to have light-chain-only disease. Ninety-seven percent of
patients diagnosed with multiple myeloma have a detectable paraprotein in the blood
serum and/or urine.

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Table 20. Distribution of Monoclonal Proteins in Secretory Multiple Myeloma
Monoclonal Proteins at Diagnosis
Source of monoclonal proteins
Serum monoclonal proteins
Urine monoclonal proteins
Type of monoclonal proteins
IgG
IgA
Monoclonal light chain
(light-chain-only disease)
IgD

Percent
80%
75%
50-54%
20%
20%
2%

Kyle RA, et al. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003;78(1):21-33.
International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related
disorders: a report of the International Myeloma Working Group. Br J Haem. 2003;121(5):749-57.

Nonsecretory Multiple Myeloma:
In some myeloma patients, the malignant plasma cells do not produce an excess of the
heavy chain or light chain portion of the immunoglobulin molecule; therefore, a
paraprotein is not detectable in the serum or urine. These patients are said to have
nonsecretory myeloma (i.e., the absence of a paraprotein on immunofixation).
Immunofixation detects the specific immunoglobulins after separating the proteins into
bands on an electrophoresis gel. Nonsecretory myeloma accounts for 3% of myeloma
cases.
Amyloidosis:
Amyloidosis is a disease in which abnormally folded proteins build up in different tissues
of the body. In the most common amyloidosis, AL amyloidosis, the abnormally folded
protein is the light chain component of an immunoglobulin. These light chains may build
up in a variety of tissues, but the most common sites of build-up are the heart, kidneys,
liver and nerves. According to the Amyloidosis Foundation, AL Amyloidosis is a
relatively rare disorder, with 1200-3200 new cases reported each year in the United
States. The disease mostly impacts men and people over 40.1
1

Amyloidosis Foundation. Amyloidosis - Primary AL. 15 Apr. 2013. Accessed at:
http://www.amyloidosis.org/TreatmentInformation/primaryAL.html
Accessibility verified on October 21, 2013.

Questions 589-590: Specify the multiple myeloma/plasma cell disorder (PCD)
classification:
Indicate the multiple myeloma/plasma cell disorder (PCD) disease classification at
diagnosis. If the subtype is not listed, report as “other plasma cell disorder” and specify
the reported disease.

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Table 21. Plasma cell disorders and characteristics
Disease

Characteristics

Multiple Myeloma
(symptomatic)

Diagnostic criteria for symptomatic multiple myeloma
requires all three of the following:
Monoclonal plasma cells in marrow (≥ 10%) or biopsyproven plasmacytoma
M-protein in serum and/or urine. If no M-protein is
detected (nonsecretory disease), then ≥ 30% plasma cells
in marrow and/or biopsy-proven plasmacytoma required
Myeloma-related organ dysfunction (≥ 1), remember the
acronym CRAB
Calcium elevation (hypercalcemia, serum calcium
> 10.5 mg/L)
Renal insufficiency (serum creatinine > 2 mg/dL)
Anemia (Hemoglobin < 10 g/dL or 2 g/dL below
normal)
Bone Disease (lytic bone lesions and/or advanced
osteoporosis)

Plasma Cell Leukemia

Peripheral blood absolute plasma cell count of at least
2.0 x 109/L (2,000 cells/mm3)
More than 20% plasma cells in the peripheral differential
white blood cell count. 1
Extramedullary:
No M-protein in serum and/or urine
Extramedullary tumor of clonal plasma cells
Normal bone marrow
Normal skeletal survey
No related organ or tissue impairment (end organ damage
including bone lesions)

Solitary Plasmacytoma
(in absence of bone
marrow findings
diagnostic for multiple
myeloma or plasma cell
leukemia)

Bone Derived
No M-protein in serum and/or urine
Single area of bone destruction due to clonal plasma cells
Bone marrow not consistent with multiple myeloma
Normal skeletal survey (and MRI of spine and pelvis if
done)
No related organ or tissue impairment (no end organ
damage other than solitary bone lesion) 1
Note: if the recipient has greater than one plasmacytoma, but has
not been diagnosed with another plasma cell disorder, select
“other plasma cell disorder” and specify how many plasmacytomas
are present and if each is bone derived or extramedullary.

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Table 21. Plasma cell disorders and characteristics (cont.)
Disease

Characteristics

Amyloidosis

Amyloidosis is the buildup of abnormally folded proteins in
various tissues of the body. Affected tissues may include the
kidneys, heart, liver, gastrointestinal tract, etc. In the most
common type of amyloidosis, “AL amyloidosis,” light chains
from antibodies function as the amyloid protein, building up
within organs and disrupting organ function. Serum and
urine tests are useful for evaluating amyloidosis, but a tissue
biopsy is the best way to diagnose the condition.
POEMS syndrome is poorly understood, but generally refers
to polyneuropathy, organomegaly, endocrinopathy, M
protein, and skin changes. Diagnosis may be made using
the presence of the major criteria and one minor criteria
below:

Osteosclerotic
myeloma/ POEMS
Syndrome

Major Criteria (both of the following):
Polyneuropathy
Monoclonal plasmaproliferative disorder
Minor Criteria (at least one of the following):
Sclerotic bone lesions†
Castleman disease†
Organomegaly (splenomegaly, hepatomegaly,
lymphadenopathy)
Edema (edema, pleural effusion, or ascites)
Endocrinopathy (adrenal, thyroid‡, pituitary, gonadal,
parathyroid, pancreatic‡)
Skin changes (hyperpigmentation, hypertrichosis,
plethora, hemangiomata, white nails)
Papilledema
†

Osteosclerotic lesion or Castleman disease is usually present.
Because of the high prevalence of diabetes mellitus and thyroid abnormalities, this
diagnosis alone is not sufficient to meet this minor criterion.2
‡

Light Chain Deposition
Disease

Similar to amyloidosis, light chain deposition disease is
characterized by the overproduction and deposition of light
chains in organs throughout the body; however, the organ
most often affected is the kidneys. Under microscopy, the
pattern of deposition and the use of staining techniques help
pathologists differentiate between amyloidosis and light
chain deposition disease.3

1

The International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma, and
related disorders: a report of the international myeloma working group. Brit J Haematol. 2003;121(5):749-57.
2

Dispenzieri A, Kyle RA, Lacy MQ, et al. POEMS syndrome: definitions and long-term outcome. Blood. 2003;101(7):2496-506.

3

UNC Kidney Center, University of North Carolina. Light Chain Deposition Disease. 5 Apr. 2013. Accessed at:
http://www.unckidneycenter.org/kidneyhealthlibrary/lightchain.html
Accessibility verified on October 21, 2013

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For recipients diagnosed with more than one PCD, either sequentially or concurrently,
ensure that all applicable questions are completed.
If the recipient’s disease classification is one of the following, continue with question
591.
1. Multiple myeloma - IgG
2. Multiple myeloma - IgA
3. Multiple myeloma - IgD
4. Multiple myeloma - IgE
5. Multiple myeloma - IgM (not Waldenstrom macroglobulinemia)
6. Multiple myeloma - light chain only
If the recipient’s disease classification is the following, neither kappa nor lambda light
chains will be present; therefore, continue with question 592.
7.

Multiple myeloma – non-secretory

If the recipient’s disease classification is one of the following, continue with question
597.
8.

Plasma cell leukemia

9.

Solitary plasmacytoma (no evidence of myeloma)

10.

Amyloidosis

11.

Osteosclerotic myeloma/POEMS syndrome

12.

Light chain deposition disease

If the recipient’s disease classification is the following, continue with question 590.
13.

Other Plasma Cell Disorder

Question 591: Light Chain
Indicate the presence of light chains as either kappa or lambda.
Questions 592-593: What was the Durie-Salmon staging (at diagnosis)?
Indicate Durie-Salmon stage and sub-classification at diagnosis. If this is not
documented in the medical record, see Table 12 below to determine the appropriate
stage and sub-classification. If “unknown,” continue with question 594.

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Table 22. Durie-Salmon Staging System for Multiple Myeloma
Stage

Criteria

I

II

All of the following:
Hemoglobin > 10 g/dL
Serum calcium normal (≤ 12 mg/dL)
On radiograph, normal bone structure or solitary bone
plasmacytoma only
Low M-component production rate (IgG < 5 g/dL, IgA < 3 g/dL),
Urinary light chain M-component on electrophoresis (< 4 g/24 hr)
Fitting neither stage I nor stage III

III

One or more of the following:

Subclassification
(either A or B)

Hemoglobin < 8.5 g/dL
Serum calcium > 12 mg/dL
Advanced lytic bone lesions (three or more lytic lesions)
High M-component product rate (IgG > 7 g/dL, IgA > 5 g/dL),
Urinary light chain M-component on electrophoresis (> 12 g/24 hr)
A: Relatively normal renal function (serum creatinine < 2.0 mg/dL)
B: Abnormal renal function (serum creatinine ≥ 2.0 mg/dL)

Adapted from Durie BG, Salmon SE: A clinical staging system for multiple myeloma: Correlation of measured myeloma cell mass
with presenting clinical features, response to treatment, and survival. Cancer. 1975;36:842-54.

Questions 594-596: Stage at Diagnosis: I.S.S.
Report the recipient’s lab values from diagnosis and the ISS stage of myeloma.
Question 597: Were cytogenetics tested (conventional or FISH)?
Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing
blood or bone marrow for the presence of a known chromosomal abnormality that
reflects the recipient’s disease. Testing methods you may see include conventional
chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For
more information about cytogenetic testing and terminology, see Appendix R,
Cytogenetic Abbreviations and Terminology.
Indicate if cytogenetic studies were obtained at any time prior to the start of the
preparative regimen. If cytogenetic studies were obtained, select “yes” and continue
with question 598.
If no cytogenetic studies were obtained or if it is unknown if chromosome studies were
performed, select “no” or “unknown” and continue with question 619.
Question 598: Results of test:
If cytogenetic studies identified abnormalities, indicate “abnormalities identified” and
continue with question 599.

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If cytogenetic studies yielded “no evaluable metaphases” or there were “no
abnormalities” identified, continue with question 619.
Questions 599-618: Specify abnormalities identified at any time prior to the start
of the preparative regimen:
Report all abnormalities identified by all methods of cytogenetic assessment at any time
prior to the start of the preparative regimen by selecting “yes” or “no” for each question.
Do not leave any response blank. If one or more abnormalities are best classified as
“other abnormality” select “yes” for question 617 and specify the abnormality in question
618.
Question 619: What was the disease status?
Indicate the disease status of the PCD at the last evaluation prior to the start of the
preparative regimen.
Table 23. Disease Status for PCD
Disease Status

Definition

Stringent Complete
Remission (sCR)

Follows criteria for CR as defined below, plus all of the following:
Normal free light chain ratio,
Absence of clonal cells in the bone marrow by
immunohistochemistry or immunofluorescence (confirmation
with repeat bone marrow biopsy not needed). (Presence and/or
absence of clonal cells is based upon the κ/λ ratio. An abnormal
κ/λ ratio by immunohistochemistry and/or immunofluorescence
requires a minimum of 100 plasma cells for analysis. An
abnormal ratio reflecting the presence of an abnormal clone is
κ/λ of > 4:1 or < 1:2.)
sCR requires two consecutive assessments (by the same method)
made at any time before the institution of any new therapy. If
radiographic studies were performed, there must be no known evidence
of new or progressive bone lesions. Radiographic studies are not
required to satisfy sCR requirements.

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Table 23. Disease Status for PCD (cont.)
Disease Status

Definition

Complete
Remission (CR)

A treatment response where all of the following criteria are met:
Negative immunofixation on serum and urine samples
Disappearance of any soft tissue plasmacytomas
< 5% plasma cells in the bone marrow (confirmation with repeat
bone marrow biopsy not needed)
NOTE: CR Requirements
For recipients with light chain only myeloma, all of the following
criteria must be met:
Normal serum free light chain ratio
Negative immunofixation on urine samples
Disappearance of any soft tissue plasmacytomas
< 5% plasma cells in the bone marrow (confirmation
with repeat bone marrow biopsy not needed)
For recipients with non-secretory myeloma, all of the following
criteria must be met:
Disappearance of all soft tissue plasmacytomas
< 5% plasma cells in the bone marrow (confirmation
with repeat bone marrow biopsy not needed)

Near Complete
Remission (nCR)

CR requires two consecutive assessments (by the same method) made
at any time before the institution of any new therapy. If radiographic
studies were performed, there must be no known evidence of new or
progressive lesions. Radiographic studies are not required to satisfy CR
requirements.
A treatment where all of the following criteria met:
Serum and Urine M-protein detectable by
immunoelectrophoresis (immunofixation, IFE) but not on
electrophoresis (SPEP and UPEP)
≤ 5% plasma cells in bone marrow.
nCR requires two consecutive assessments (by the same
method) made at any time prior to the initiation of any new
therapy, and no known evidence of new or progressive bone
lesions if radiographic studies were performed; radiographic
studies are not required to satisfy nCR requirements.

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Table 23. Disease Status for PCD (cont.)
Disease Status

Definition

Very Good Partial
Response (VGPR)

One or more of the following must be present:

Partial Response
(PR)

Serum and urine M-protein detectable by immunofixation but not
on electrophoresis
≥ 90% reduction in serum M-protein and urine M-protein level
< 100 mg/24 hours.
VGPR requires two consecutive assessments (by the same method)
made at any time before the institution of any new therapy. If
radiographic studies were performed, there must be no known evidence
of new or progressive bone lesions. Radiographic studies are not
required to satisfy VGPR requirements.
Both of the following must be present:
≥ 50% reduction in serum M-protein
Reduction in 24-hour urinary M-protein by ≥ 90% or to < 200
mg/24 hours.
If the serum and urine M-protein are not measurable (i.e., do not meet
the following criteria at time of diagnosis):
Serum M-protein ≥ 1 g/dL
Urine M-protein ≥ 200 mg/24 hours;
then a ≥ 50% decrease in the difference between involved and
uninvolved free light chain levels is required in place of the M-protein
criteria (provided the serum free light chain assay shows involved level
> 10 mg/dL and the serum free light chain is abnormal).
If serum and urine M-protein and serum-free light assay are not
measurable, a ≥ 50% reduction in bone marrow plasma cells is required
in place of M-protein, provided the baseline bone marrow plasma cell
percentage was ≥ 30%.
In addition to the above-listed criteria, if soft tissue plasmacytomas
were present at baseline, a ≥ 50% reduction in their size is also
required.

Stable Disease (SD)

PR requires two consecutive assessments (by the same method) made
at any time before the institution of any new therapy. If radiographic
studies were performed, there must be no known evidence of new or
progressive bone lesions. Radiographic studies are not required to
satisfy PR requirements.
Does not meet the criteria for CR, VGPR, PR, or PD.
SD requires two consecutive assessments (by the same method) made
at any time before the institution of any new therapy. If radiographic
studies were performed, there must be no known evidence of new or
progressive bone lesions. Radiographic studies are not required to
satisfy SD requirements.

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Table 23. Disease Status for PCD (cont.)
Disease Status

Definition

Progressive
Disease (PD)

Requires one or more of the following:
Increase of ≥ 25% from the lowest response value achieved in:
Serum M-component with an absolute increase ≥ 0.5 g/dL (for
progressive disease, serum M-component increases of ≥ 1 g/dL
are sufficient if the starting M-component is ≥ 5 g/dL); and/or
Urine M-component with an absolute increase ≥ 200 mg/24
hours; and/or
For recipients without measurable serum and urine M-protein
levels, the difference between involved and uninvolved free light
chain levels with an absolute increase > 10 mg/dL; and/or
Bone marrow plasma cell percentage with absolute percentage
≥ 10%; and/or
Definite development of new bone lesions or soft tissue
plasmacytomas, or definite increase in the size of any existing
bone lesions or soft tissue plasmacytomas; and/or
Development of hypercalcemia (corrected serum calcium > 11.5
mg/dL or 2.65 mmol) that can be attributed solely to the plasma
cell proliferative disorder.

Relapse from CR
(untreated)

PD requires two consecutive assessments (by the same method) made
at any time before classification as disease progression and/or the
institution of any new therapy.
Requires one or more of the following:
Reappearance of serum or urine M-protein by immunofixation or
electrophoresis; and/or
Development of ≥ 5% plasma cells in the bone marrow; and/or
Appearance of any other sign of progression (e.g., new
plasmacytoma, lytic bone lesion, hypercalcemia).
Relapse requires two consecutive assessments (by the same method)
made at any time before classification as relapse, and/or the institution
of any new therapy.

At any response level, if some but not all criteria are met, the disease status should be
downgraded to next lower level of response.
The percentage of plasma cells in the bone marrow aspirate and/or biopsy may also be
identified on a flow cytometry report. A flow cytometry report may NOT be used to
confirm CR (e.g., < 5% plasma cells in the bone marrow).
For more information on determining how to report disease status prior to the
preparative regimen, see Appendix V.

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CIBMTR Form 2400

If the disease response prior to transplant is unknown, select “unknown” and continue
with the signature line.
If the recipient had amyloidosis, but no evidence of myeloma, select “not applicable
(Amyloidosis with no evidence of myeloma)” and continue with the signature line.
Example 1: A 62-year-old man is diagnosed with IgG Kappa multiple myeloma. He
receives initial therapy with 6 cycles of bortezomib and lenalidomide/dexamethasone;
and achieves a near complete remission (nCR). The values used to determine
disease status at transplant are the values obtained at diagnosis.
Time
Point
10/31/2008

4/3/2009

BMBX
27%
plasma
cells
3%
plasma
cells

4/17/2009
5/13/2009

SPEP

SIFE

3.3 g/dL

+

Negative
Negative

+
+

UPEP
336
mg/24
hours

UIFE

Skeletal
Survey

+

Negative

Negative
Negative

Negative
Negative

5/17/2009

Treatment

Disease
Status

Bortezomib/
lenalidomide/dex

Diagnosis:
IgG Kappa

nCR
nCR
(confirmatory)
Autologous HCT

Example 2: A 59-year-old woman is diagnosed with IgA Lambda multiple myeloma.
She receives bortezomib and thalidomide/dexamethasone as initial treatment and
achieves a CR. A few months later she has evidence of relapse. She is then treated
with lenalidomide/dexamethasone and achieves a PR. The patient receives highdose cyclophosphamide as part of an autologous stem cell harvest. The values used
to determine disease status at transplant would be the values obtained at the time of
relapse.
Time Point
01/27/2010

02/01/2010

BMBX

SPEP
4.5 g/dL

SIFE
+

UPEP
Negati
ve

UIFE
Negative

Treatment

Aspirate
=18%
plasma
cells;
biopsy=
sheets of
plasma
cells
Negativ
e

03/05/2010
4/5/2010
5/5/2010

2.6 g/dL
1.7 g/dL
0.5 g/dL

+
+
+

6/4/2010

0.03 g/dL

+

0.01 g/dl

+

1%
plasma
cells

Disease
Status

Diagnosis:
IgA lambda

02/05/2010

8/18/2010

Skeletal
Survey

Negati
ve

Bortezomib/
thalidomide/d
ex

Negative

© 2013 National Marrow Donor Program ® and The Medical College of Wisconsin
Document Title: CIBMTR Forms Manual: Pre-Transplant Essential Data Form 2400
Version 3.0 (10/2013)
Page 103 of 106

Instructions for Recipient Pre-TED Data
CIBMTR Form 2400

Example 2 (cont.)
Time Point

BMBX

9/15/2010
10/15/2010
11/15/2010
12/15/2011
1/15/2011

SPEP
Not
detected
Not
detected
Not
detected
Not
detected

SIFE

Disease
Status

(no treatment
given)

CR
(confirmatory)

Negative

+

3/15/3011
4/15/2011

1.4 g/dL
0.9 g/dL

+
+

5/15/2011

0.7 g/dL

+

0.5 g/dL

+

3%
plasma
cells

Treatment

CR

Negative

2.2 g/dL

6/15/2011

Skeletal
Survey

Negative

+

7%
plasma
cells

UIFE

+

1.9 g/dL

2/15/2011

UPEP

Negati
ve

Negative

Relapse
Negativ
e

lenalidomide/
dexamethaso
ne

Relapse
(confirmatory)
PR
PR
(confirmatory)

Autologous
HCT

7/31/2011

Question 620: Date Assessed:
Enter the date of the most recent assessment of disease status prior to the start of the
preparative regimen. Report the date the blood/urine was collected for the laboratory
evaluations (e.g., SPEP/UPEP, serum/urine immunofixation) or report the date the bone
marrow was collected for pathological evaluation. A PET scan may be used if a
previous PET scan had been obtained and only in limited circumstances (e.g.,
plasmacytomas, lytic lesions).
If the exact date is not known, use the process for reporting partial or unknown dates as
described in General Instructions, Guidelines for Completing Forms.

Solid Tumors
Questions 621-622: Specify the solid tumor classification:
Indicate the solid tumor disease classification at the time of diagnosis. Germ cell tumors
that originate in the ovary or testes should be reported as ovarian or testicular,
respectively. If the subtype is not listed, report as “Other solid tumor” and specify the
reported malignancy in question 622. If a certain disease becomes a common indication
for HCT, the CIBMTR will add the disease as a separate category.

© 2013 National Marrow Donor Program ® and The Medical College of Wisconsin
Document Title: CIBMTR Forms Manual: Pre-Transplant Essential Data Form 2400
Version 3.0 (10/2013)
Page 104 of 106

Instructions for Recipient Pre-TED Data
CIBMTR Form 2400

Severe Aplastic Anemia
Questions 623-624: Specify the severe aplastic anemia classification:
Indicate the severe aplastic anemia disease classification at diagnosis. If the subtype is
not listed, report as “other acquired cytopenic syndrome” and specify the reported
disease. If a certain disease becomes a common indication for HCT, the CIBMTR will
add the disease as a separate category.

Inherited Abnormalities of Erythrocyte Differentiation or Function
Questions 625-627: Specify the inherited abnormalities of erythrocyte
differentiation or function classification
Indicate the inherited abnormalities of erythrocyte differentiation or function disease
classification at diagnosis. If the subtype is not listed, report as “other constitutional
anemia” or “other hemoglobinopathy” and specify the reported disease. If a certain
disease becomes a common indication for HCT, the CIBMTR will add the disease as a
separate category.

Disorders of the Immune System
Questions 628-630: Specify disorder of immune system classification:
Indicate the disorder of the immune system’s disease classification at diagnosis. If the
subtype is not listed, report as “other SCID” or “other immunodeficiency” and specify the
reported disease. If a certain disease becomes a common indication for HCT, the
CIBMTR will add the disease as a separate category.

Inherited Abnormalities of Platelets
Questions 631-632: Specify inherited abnormalities of platelets classification:
Indicate the inherited abnormalities of platelets disease classification at diagnosis. If the
subtype is not listed, report as “other inherited platelet abnormality” and specify the
reported disease. If a certain disease becomes a common indication for HCT, the
CIBMTR will add the disease as a separate category.

Inherited Abnormalities of Metabolism
Questions 633-634: Specify inherited abnormalities of metabolism classification:
Indicate the inherited abnormalities of metabolism disease classification at diagnosis. If
the subtype is not listed, report as “inherited metabolic disorder, not otherwise specified”
and specify the reported disease. If a certain disease becomes a common indication for
HCT, the CIBMTR will add the disease as a separate category.

© 2013 National Marrow Donor Program ® and The Medical College of Wisconsin
Document Title: CIBMTR Forms Manual: Pre-Transplant Essential Data Form 2400
Version 3.0 (10/2013)
Page 105 of 106

Instructions for Recipient Pre-TED Data
CIBMTR Form 2400

Histiocytic Disorders
Questions 635-636: Specify the histiocytic disorder classification:
Indicate the histiocytic disorder disease classification at diagnosis. If the subtype is not
listed, report as “other histiocytic disorder” and specify the reported disease in question
636. If a certain disease becomes a common indication for HCT, the CIBMTR will add
the disease as a separate category.

Autoimmune Diseases
Questions 637-644: Specify autoimmune disease classification:
Indicate the autoimmune disease classification at diagnosis. If the subtype is not listed,
report as “other arthritis,” “other connective tissue disease,” “other vasculitis,” “other
autoimmune neurological disorder,” “other autoimmune cytopenia,” or “other
autoimmune bowl disorder,” and specify the reported disease. If a certain disease
becomes a common indication for HCT, the CIBMTR will add the disease as a separate
category.

Other Disease
Question 645: Specify other disease:
Before using this category, check with a transplant physician to determine whether the
disease can be classified as one of the listed options in the Disease Classification
questions. Examples include: erythropoietic protoporphyria (EPP), and dystrophic
epidermolysis bullosa (DEB).

Signature
The FormsNet3SM application will automatically populate the signature data fields,
including name and email address of person completing the form and date upon
submission of the form.

© 2013 National Marrow Donor Program ® and The Medical College of Wisconsin
Document Title: CIBMTR Forms Manual: Pre-Transplant Essential Data Form 2400
Version 3.0 (10/2013)
Page 106 of 106