pre-ted-instructions

Instructions for Pre-Transplant Essential Data (Pre-TED) Form
This section of the CIBMTR Forms Instruction Manual is intended to be a resource for
completing the Pre-Transplant Essential Data (Pre-TED) Form. Effective December 3,
2007, the Pre- and Post-TED forms replaced the former Pre-Registration (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 liaison.

TABLE OF CONTENTS
Abbreviations ........................................................................................................3
Key Fields .............................................................................................................5
CIBMTR Use Only ................................................................................................5
Disease Classification...........................................................................................5
Table 1. Common Diagnosis Combinations ...................................................6
Table 2. Common Diagnosis Transformations ................................................6
Hematopoietic Stem Cell Transplant (HSCT) .......................................................7
Preparative Regimen ..........................................................................................14
Example: Calculating Drug Doses .................................................................16
Comorbid Conditions ..........................................................................................17
GVHD Prophylaxis (allogeneic only) ...................................................................20
Post-HSCT Disease Therapy Planned as of Day 0.............................................21
Other Toxicity Modifying Regimen ......................................................................21
Pre-TED Disease Classification Sheet................................................................22
Acute Leukemias ................................................................................................23
Acute Myelogenous Leukemia or Acute Nonlymphocytic Leukemia .............23
Acute Lymphoblastic Leukemia .....................................................................26
Other Acute Leukemia...................................................................................29
Chronic Myelogenous Leukemia (CML)..............................................................32
Table 3. CML Classifcation Requirements ....................................................32

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TABLE OF CONTENTS (continued)
Myelodysplastic or Myeloproliferative Diseases..................................................36
MDS or Myeloproliferative Diseases .............................................................. 36
MDS/MPS/CMML .......................................................................................... 37
JMML ............................................................................................................. 40
Other Leukemias.................................................................................................40
Lymphomas ........................................................................................................46
Hodgkin Lymphoma....................................................................................... 46
Non-Hodgkin Lymphoma...............................................................................48
Plasma Cell Disorders ........................................................................................50
Table 4. Plasma Cell Disorders: Disease Combinations ............................... 52
Breast Cancer .....................................................................................................55
“Other” Disease...................................................................................................60
Other Malignancies .............................................................................................60
Anemia/Hemoglobinopathy.................................................................................63
Platelet Disorders................................................................................................63
Histiocytic Disorders ...........................................................................................63
Inherited Disorders of Metabolism/Osteopetrosis ...............................................64
Immune Deficiencies...........................................................................................64
Autoimmune Disorders .......................................................................................64
Connective Tissue Disease ........................................................................... 64
Vasculitis ....................................................................................................... 66
Other Vasculitis ............................................................................................. 67
Arthritis .......................................................................................................... 67
Multiple Sclerosis........................................................................................... 68
Other Autoimmune Neurological Disorder ..................................................... 68
Other Autoimmune Cytopenia ....................................................................... 68
Bowel Disease ............................................................................................... 69

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Abbreviations
The following abbreviations are used throughout the Pre- and Post-TED forms. These
abbreviations are also listed on page two of the Pre-TED paper form. For a glossary of
abbreviations and common terms used throughout the manual, see appendices A and
B.
NST = Non-myeloablative Stem Cell
Transplant
PBSC = Peripheral Blood Stem Cells
PTLD = Posttransplant
Lymphoproliferative Disorder
RBC = Red Blood Cell
RCI-BMT = Resource for Clinical
Investigations in Blood & Marrow
Transplant
RIC = Reduced Intensity Conditioning
SCTOD = Stem Cell Therapeutic
Outcomes Database
TBI, TLI, TNI = Total (Body, Lymphoid,
Nodal) Irradiation
U = Unclassifiable
UCB = Umbilical Cord Blood
Unit = Adult, Hematology, Oncology,
Pediatric (AHOP)
VOD = Veno-occlusive Disease

YYYY = 4-digit year
MM = 2-digit month
DD = 2-digit day
AHOP = Adult, Hematology, Oncology
or Pediatric Unit
ALLO = Allogeneic
ANC = Absolute Neutrophil Count
AUTO = Autologous
BM = Bone Marrow
BMT-CTN = Blood & Marrow
Transplant Clinical Trials Network
CIBMTR = Center for International
Blood & Marrow Transplant Research
CIC = Center Identification Code
CMV = Cytomegalovirus
CR = Complete Remission
DCI = Donor Cellular Infusion
DLI = Donor Lymphocyte Infusion
EBMT = European Group for Blood &
Marrow Transplantation
EBV = Epstein Barr Virus
FACT = Foundation for the
Accreditation of Cellular Therapy
FGF = Fibroblast Growth Factor (e.g.,
velafermin)
FISH = Fluorescent In-situ
Hybridization
GVHD = Graft versus Host Disease
HSCT = Hematopoietic Stem Cell
Transplant
KGF = Keratinocyte Growth Factor
(e.g., Kepivance)
NMDP = National Marrow Donor
Program
NOS = Not Otherwise Specified
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Pre-Transplant Essential Data (Pre-TED)
All transplant centers participating in the CIBMTR must submit a Pre-TED Form
for each recipient receiving a first allogeneic (related or unrelated) HSCT. 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.
Transplant centers are encouraged to submit a Pre-TED for recipients receiving
an autologous HSCT. Although data regarding recipients receiving autologous
HSCT 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. For more information regarding data reporting for
autologous HSCT, 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. The Pre-TED is due the day of the HSCT
(day 0), and is past due if not received by that date.
Helpful Hint:
In order to minimize potential changes to HSCT date, complete the data for the
Pre-TED (in FormsNet™2 or on paper), but do not submit the Form until the first
dose of the preparative regimen is given.
For recipients receiving a subsequent HSCT:
•

TED only centers must submit a Pre-TED for all subsequent HSCTs.

•

Comprehensive Report Form centers must submit a Pre-TED only for
recipients assigned to TED forms by the form selection algorithm. For
recipients assigned to Comprehensive Report Forms by the form
selection algorithm, centers will not submit another Pre-TED, but will
instead submit a Baseline Form (Form 2000).

For all subsequent HSCTs, the recipient will remain on the original followup 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.
For recipients of multiple transplants (and who are assigned to the TED forms),
transplant centers are not granted access to the current Pre-TED form in
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FormsNetTM2 until the Post-TED from the previous transplant has been
completed.
Transplant centers can use the FormsNetTM2 application to determine if a
Baseline Form (Form 2000) is due either by 1) accessing the Forms Due Report,
or 2) by 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.

•

Transplant centers have access to their data.

•

Data are being shared with the correct donor center, cord blood bank,
cooperative registry, or other approved agency.

For instructions regarding the completion of the Key Fields, see appendix K. Key
fields include all fields listed in the Center Identification and Recipient
Identification boxes.

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 FormsNetTM2 application.
Do not write in this box.

Disease Classification
NOTE: Disease Classification
The newest version of the TED forms uses the World Health Organization (WHO)
disease classifications. Each Disease Classification Sheet contains all of the
established WHO disease types and subtypes. Therefore, the “other, specify”
category should only be used if the recipient’s disease is not one of the listed
options. For more information regarding disease classification, consult with a
transplant physician, contact your center’s CIBMTR liaison, or visit the WHO
website at: http://www.who.int/classifications/icd/en/.
If the indication for HSCT is due to a combination of diseases or a transformation
of one disease to another, multiple Disease Classification Sheets may be
required. Tables 1 and 2 list common examples of disease combinations and
transformations, and the Disease Classification Sheets required.
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Table 1. Common Disease Combinations
Disease Combinations

Report primary
disease as:

Report disease
diagnosis date
of:

FAN or SAA and AML

AML

AML

FAN or SAA and MDS

MDS

MDS

MYE and AMY

MYE

MYE

Required disease
classification sheet(s)
Anemia/Hemoglobinopathy
and AML
Anemia/Hemoglobinopathy
and MDS
Plasma Cell Disorders

Table 2. Common Disease Transformations
Disease Transformation
MDS or MPS to AML
NHL to another NHL
CLL to NHL
(i.e., Richter’s Syndrome)

Report primary
disease as:
AML
Second NHL
diagnosis
NHL

Report disease
diagnosis date of:
AML

Required disease
classification sheet(s)
AML and MDS/MPS

First NHL diagnosis

Lymphoma

CLL

Other Leukemias and
Lymphoma

NOTE:
Question numbers correspond to the FormsNetTM2 application
Question 1: Date of diagnosis of primary disease for HSCT
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.
Do not report the date symptoms first appeared. The date of diagnosis is
important because the interval between diagnosis and HSCT is often a significant
indicator for the recipient’s prognosis post-HSCT.
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 HSCT for a new malignancy (or other new indication),
report the date of diagnosis of the new malignancy and complete the appropriate
Disease Classification Sheet. If the recipient is assigned to the TED forms by the
forms selection algorithm, the diagnosis date and current status of the previous
diagnosis will be reported on the Post-TED.

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Hematopoietic Stem Cell Transplant (HSCT)
Question 2: Date of this HSCT
Report the intended start date of the HSCT. If the infusion is planned to last
several days, enter the day the infusion is scheduled to start.
If the Pre-TED has been submitted prior to day 0, and the planned infusion date
has changed, the original planned date of the HSCT will automatically be
reported in FormsNetTM2 on either the Post-TED or the 100 Days Post-HSCT
Data Form (Form 2100). The Pre-TED should be changed using the paper Error
Correction Form process. This will change the transplant date for the subsequent
form(s).
If the recipient is scheduled to receive a combination of cellular therapy and stem
cell infusions, contact your center’s CIBMTR liaison for reporting requirements.
Question 3: Chronological number of this HSCT
An HSCT event is defined as an infusion of mobilized peripheral blood stem cells
(PBSC), bone marrow, or cord blood. For recipients who have received a
previous HSCT (prior to the HSCT for which this series of forms is being
completed), the following are examples of how to calculate the chronological
number of this HSCT.
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 HSCT event, as opposed to three HSCT
events and should be counted as HSCT Event #1.
After receiving the infusion, the recipient has relapse of disease. The
recipient is scheduled to receive a subsequent HSCT. This HSCT should
be reported as HSCT Event #2.
Example 2:
A recipient previously received a HSCT (HSCT Event #1). Then, because
of delayed neutrophil recovery, the recipient received additional mobilized
cells (i.e., “boost” - HSCT Event #2).
After receiving the boost, the recipient has relapse of disease. The
recipient is scheduled to receive a subsequent HSCT. This HSCT should
be reported as HSCT Event #3.

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Autologous rescue should not be counted as a separate HSCT. Autologous
rescue is generally used to treat the recipient’s poor graft response, rather than
their disease.
Question 4: If >1, most recent previous HSCT
Report the date of the recipient’s last autologous or allogeneic (related or
unrelated) HSCT. Although the CIBMTR requests either a Pre-TED and/or
Recipient Baseline Data (Form 2000) for each HSCT, there may be
circumstances where a prior HSCT was not reported (e.g., prior autologous
HSCT). Reporting the recipient’s last HSCT enables the CIBMTR to appropriately
account for recipient survival status in the database.
Question 5: Type (of most recent previous HSCT)
Report the stem cell source of the recipient’s last HSCT as either autologous or
allogeneic.
Questions 6-9: Institution where previous HSCT was performed, if different
from current
Report the name, city, state and country of the institution where the recipient’s
last HSCT 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.
NOTE: Questions 10-18
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 10-14: Cell source for this HSCT
More than one cell source or a combination of cellular therapies may be infused
in the same HSCT procedure. Select all the cell sources planned for use in the
current HSCT.
If “other” is chosen, specify the cell source type.
For more information regarding multiple cell type infusions that occur over a short
period of time (e.g., less than two weeks), contact your center’s CIBMTR liaison.
Questions 15-16: Allo HSCT donor gender
Indicate each allogeneic donor’s biological gender (sex) as “male” or “female.”
For multiple donors, check all that apply. For autologous HSCT, leave this
question blank and continue with question 17.
Question 17: Autologous HSCT?
Indicate if this HSCT is autologous (self-donation).
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Question 18: Multiple donors?
Indicate if multiple donor types, or if multiple cord blood units from different
donors are to be used for this HSCT.
Question 19: Donor Type
If the product for this HSCT is from an allogeneic donor, indicate the donor type.
•

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 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).
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 bloodrelated relatives who have at least one HLA mismatch (e.g.,
parents, aunts, uncles, children, cousins).
Does not include: Adoptive parents/children or
stepparents/children.
If the donor is an HLA-mismatched relative, continue with “degree of
mismatch” (question 20). If the donor is an HLA-matched relative,
continue with the “ex vivo graft manipulation” section (question 25).

•

Unrelated donor:
Includes: Donor who shares no known ancestry with the recipient,
and is usually found through an unrelated donor registry. Include
adoptive parents/children or stepparents/children here. Continue
with “registry or UCB bank” (question 21).
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Question 20: Degree of mismatch
If the donor is an HLA-mismatched relative, indicate the degree of mismatch as
either, “1 HLA antigen mismatch” or, “≥ 2 HLA antigen mismatch (full
Haploidentical).” Haploidentical means that one half of the HLA type matches the
recipient. This type of HLA mismatch is common between blood-related parents
and children.
Question 21: Registry or UCB Bank
For unrelated donors, specify the registry used to obtain the adult donor or
umbilical cord blood unit. The code for NMDP donors is USA1. The code for
NMDP cord blood units is U1CB. The Bone Marrow Donors Worldwide (BMDW)
codes have been adopted to avoid submitting the entire name and address of the
donor registry.
A donor found through DKMS should be reported as a ZKRD donor. DKMS is
part of both the ZKRD registry as well as the NMDP registry.
NOTE: Question 21
FormsNet 2 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
TM

Example: Registry name: Against Leukemia Foundation Marrow Donor
Registry
Match codes: Poland-ALF MDR [PL3]
Report on Pre-TED: PL3
Question 22: 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. This option should be used in rare circumstances.
Question 23: Complete number of mismatches: Antigenic (2 digits)
For unrelated donors, if HLA testing was serologic or low-resolution DNA typing,
indicate the number of mismatches for each locus (Note: A full match equals “0”
mismatches). If multiple unrelated donors are used for this HSCT, complete the
section for donor registry or cord blood unit, then draw a single line through the
HLA mismatch section, and indicate “multiple donors used,” or override this error
in the FormsNet™2 application.
Question 24: Complete number of mismatches: Allelic (4 digits)
For unrelated donors, if HLA testing was intermediate- or high-resolution DNA
typing, indicate the number of mismatches for each locus. If multiple donors are
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used for this HSCT, complete the section for donor registry or cord blood unit,
then draw a single line through the HLA mismatch section, and indicate “multiple
donors used,” or override this error in the FormsNet™2 application. For
assistance with HLA typing and terminology, consult a specialist within your
institution, or contact your center’s CIBMTR liaison.
Question 25: Was there Ex Vivo Graft Manipulation other than for RBC
removal or volume reduction?
Ex vivo refers to outside the body. Do not report treatments given to the recipient
with the intent of affecting the graft.
If the graft was manipulated ex vivo other than for RBC removal or volume
reduction, check “yes” and continue with question 26.
If the graft was only manipulated to reduce the volume of the collection (plasma
removal), or to remove RBCs (for ABO incompatibility, to prevent hemolysis),
check “no” and continue with question 34.
NOTE: Questions 26-33
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Question 26: T-cell depletion
This method of negative selection manipulation is most commonly used for
allogeneic HSCT, as it removes some or all of the T-cells to minimize GVHD. The
removed T-cells may be infused at a later date (i.e., DLI). Methods of T-cell
depletion may include the use of antibodies. For more detail regarding methods
of T-cell depletion, see the HSCT Infusion Form (INF Form 2006).
Question 27: Tumor purging
This type of negative selection manipulation removes malignant cells from the
collected product. This method is only used for autologous HSCT.
Questions 28-29: Other negative selection
Negative selection refers to removing a specific cell population prior to infusion. If
a negative selection method of cell manipulation was used, other than T-cell
depletion or tumor purging, check “yes” and specify the method in the space
provided.
Question 30: CD34 selection
This manipulation method is also known as “positive selection.” This method
collects stem cells that have a CD34+ marker on the surface cell, and is
commonly done with a CliniMACS/CliniMax or Isolex machine.

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Question 31: Ex-vivo expansion
Using a positive selection manipulation technique, CD34+ cells are selected for
ex-vivo expansion to increase the quantity of hematopoietic stem cells between
collection and infusion. The most common method of ex vivo expansion uses
hematopoietic growth factors. Ex-vivo expansion is most commonly used with
cord blood transplants.
Questions 32-33: Other, specify
If a positive selection method of cell manipulation was used, other than CD34+
selection or ex vivo expansion, check “yes” and specify the method in the space
provided.
Questions 34-35: Performance Score pre-Preparative Regimen
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-HSCT
work-up phase, or approximately one month 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.
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.
Recipient performance status is a critical data field that has been determined to
be essential for all outcome-based studies. 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; whereas, a Karnofsky/Lansky score of “80” or “90” is
converted directly to an ECOG score of “one.” Therefore, the Karnofsky/Lansky
scale can be more accurately converted into ECOG.
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However, 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 to
account for the lack of direct mapping. This practice should be clear and
reproducible.

For more information regarding converting an EGOG score to a
Karnofsky/Lansky score, see appendix L.
Questions 36-37: CMV-antibodies (IgG or Total)
Report the cytomegalovirus (CMV) status of the recipient—and for allogeneic
HSCTs, the donor—immediately prior to the start of the preparative regimen. For
the purposes of this manual, the term “immediately prior” represents the preHSCT work-up phase, or approximately one month prior to 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-HSCT work-up phase. Therefore a
timeframe of greater than one month prior to the start of the preparative regimen
is acceptable.
A large portion of the population has been exposed to CMV. Following acute
infection in the tissues, CMV remains dormant. Primary infection or reactivation
of CMV can lead to significant infections and substantial complications for
transplant recipients. Prior exposure to CMV, and therefore potential for
reactivation, is generally tested during the pre-transplant recipient and donor
evaluation. It is estimated that 50%-90% of adults test positive for CMV antibody,
but are asymptomatic.
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, the laboratory value must be compared to the reported
standards for reactive or non-reactive at the center. Use the “unknown” option
only if the test has been completed, but the test results are not known. Selecting
the “unknown” option may require a future data query. Use the “not done” option
only if CMV status was not evaluated prior to the start of the preparative regimen.
If multiple donors are used for this HSCT, report any positive result as reactive.

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Preparative Regimen
Question 38: Was a preparative regimen given?
Recipients are generally transplanted under a specific protocol that defines the
radiation and/or chemotherapy 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 may not be given.
Examples may include, but are not limited to:
•

Primary diagnosis of an immune deficiency.

•

Subsequent allogeneic HSCT due to loss of, or poor, neutrophil
engraftment.

If a preparative regimen is prescribed per protocol, check “yes” and continue with
question 39. If a preparative regimen is not planned, check “no” and continue
with question 119.
For more information regarding the recipient’s preparative regimen, consult with
a transplant physician, or contact your center’s CIBMTR liaison.
NOTE: Questions 39-111
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Preparative Regimen: Radiation
The following questions refer to prescribed radiation therapy. Do not report the
radiation dose that was actually given. If the recipient is assigned to the
Comprehensive Report Forms by the forms selection algorithm, then the actual
dose given will be reported on the baseline form (Form 2000).
Question 39: Total Body Irradiation (TBI)
If TBI is prescribed per protocol, check “yes” and continue with question 40.
Check “yes” even if certain fields (vital organs) will be blocked or shielded from
radiation. If TBI is not prescribed per protocol, check “no” and continue with
question 41.
Question 40: TBI Total Prescribed Dose
Enter the total dose of radiation as prescribed per protocol. If radiation is
prescribed as a single dose, the amount of radiation delivered in the single dose
constitutes the total dose. If the radiation is prescribed in fractionated doses,
multiply the total number of fractions by the dose per fraction to determine the
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total dose. For example, if the protocol prescribes 200 cGy of radiation given
over three days, the total dose is 600 cGy. Enter the total dose of radiation in
either grays (Gy) or centigrays (cGy).
Question 41: Limited Field
If Total Lymphoid Irradiation (TLI), Total Nodal Irradiation (TNI), or Total
Abdominal Irradiation (TAI) is prescribed per protocol, check “yes” and continue
with question 42. If TLI, TNI, or TAI is not prescribed per protocol, check “no” and
continue with question 43.
Question 42: TLI, TNI, or TAI Total Prescribed Dose
Enter the total dose of radiation as prescribed per protocol. If radiation is
prescribed as a single dose, the amount of radiation delivered in the single dose
constitutes the total dose. If the radiation is prescribed in fractionated doses,
multiply the total number of fractions by the dose per fraction to determine the
total dose. For example, if the protocol prescribes 200 cGy of radiation given
over three days, the total dose is 600 cGy. Enter the total dose of radiation in
either grays (Gy) or centigrays (cGy).
Preparative Regimen: Drugs
The following questions refer to prescribed drug therapy as 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 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.).
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
of 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 43-111: Drugs
Report the total dose of each drug as prescribed in the preparative regimen
section of the HSCT 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 whole number. For paper submission, do not modify the
number of boxes or include decimal values.
Report the dose units as either “mg/m2” or “mg/kg.” If the total prescribed dose is
reported a unit other than mg/m2 or mg/kg, 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 into either mg/m2 or
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g/kg, leave the unit field blank and attach a copy of the source document to the
Pre-TED using the Log of Appended Document (Form 2800).
Example: Calculating Drug Doses
Drug doses are calculated either by recipient weight or recipient body surface
area (BSA) in m2. The HSCT protocol will specify “x mg/m2” or “x mg/kg” and the
total number of doses to be administered.
To calculate the total dose administered: multiply “mg of drug per dose” x “total
number of doses.” If the dose was prescribed in grams (gm) rather than
milligrams (mg), multiply the total dose in gm by 1,000 to convert to mg.
For example, if the protocol requires Cyclophosphamide, 60 mg/kg x 2 days (i.e.,
2 doses), the “total prescribed dose” should be reported as “120 mg/kg.”
The “other, specify” category should only be used 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 Document (Form 2800).
If the Pre-TED is being completed for a subsequent HSCT, do not report therapy
that was given to treat the recipient’s disease (between the previous and current
planned HSCTs) in the preparative regimen section.
If either the drug or the prescribed dose given for the preparative regimen
changes after the Pre-TED is submitted, do not correct the Pre-TED. If the
recipient is assigned to the comprehensive Report Forms by the form selection
algorithm, the actual dose received will be reported on the Baseline Form (Form
2000). If the recipient is assigned to TED Forms by the form selection algorithm,
the actual dose given will not be reported.
Question 112: Is the intent of the preparative regimen myeloablative (allo
only)?
The purpose of a myeloablative HSCT is to destroy malignant cells using highdose chemotherapy and/or radiation therapy. A myeloablative regimen may also
be used for recipients with a non-malignant disease requiring a stem cell
transplant for marrow reconstitution (i.e., immunodeficiencies), or to produce a
complete donor chimerism.
In contrast, a non-myeloablative (NST) or reduced-intensity (RIC) preparative
regimen generally uses lower doses of chemotherapy and/or radiation therapy to
prevent graft rejection and suppress the recipient’s hematopoietic immune
system, but not eliminate it completely. A NST relies on the immune cells of the
donor to destroy the disease (called graft versus tumor, or GVT), and typically
produces a mixed chimerism. NST is a common treatment option for older
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recipients, and recipients with other health problems, as the lower chemotherapy
and/or radiation doses are easier for the recipient to tolerate.
Currently, there are no published definitions of the difference between NST and
RIC preparative regimens. However, in general, an RIC includes any regimen not
meeting the criteria for either myeloablative or NST regimens.
Centers must attribute the intent of the regimen based on the standards at their
center. Generally speaking, the attribution should be based on protocol, or the
opinion of the physician overseeing the care of the recipient at your center.
If the intent of the preparative regimen is myeloablative (produce marrow ablation
or pancytopenia), check “yes” and continue with question 119.
If the preparative regimen is intended to be NST or RIC, check “no” and continue
with question 113.
NOTE: Questions 113-118
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 113-118: Reason for NST/RIC
Indicate the reason a non-myeloablative or reduced-intensity preparative regimen
was prescribed.

Co-morbid Conditions
Questions 119-140 are optional for non-US centers.
Question 119: Is there a history of mechanical ventilation?
A history of mechanical ventilation may impact the recipient’s pulmonary function
post-HSCT. 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 a 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.

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Indications for mechanical ventilation include but are not limited to the following:
•
•
•
•
•
•
•
•
•

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
HSCT event (excluding mechanical ventilation during surgery) check “yes.” If the
recipient does not have a history of mechanical ventilation, check “no.”
Question 120: 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 culture that yields a positive result. For example, a chest x-ray that
reveals a positive node 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 HSCT event, check “yes.” For both primary and subsequent HSCT, report
any documented invasive fungal infections in the recipient’s medical history.
Examples of proven invasive fungal infections include, but are not limited to the
following: invasive aspergillosis, zygomycosis and other molds, invasive
candidiasis, cryptococcosis, endemic mycosis, other yeasts, and pneumocytosis.
Non-invasive fungal infections such as thrush and nail fungus should not be
reported.
For assistance with reporting fungal infections, consult with a transplant
physician.

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NOTE: Questions 121-140
Prior to answering question 121, review the list of co-existing disease(s) and/or
organ impairments listed under questions 122-140.
Report “yes” to question 121 if the recipient has a documented history and/or
current diagnosis of any of the following:
Documented Medical History
Arrhythmia
Cardiac
Cerebrovascular disease
Heart valve disease
Inflammatory bowel disease
Rheumatologic
Solid tumor, prior
Current diagnosis at the time of pre-HSCT evaluation
Diabetes
Hepatic, mild
Hepatic, moderate/severe
Infection
Obesity
Peptic ulcer
Psychiatric disturbance
Pulmonary, moderate
Pulmonary, severe
Renal, moderate/severe

Question Number
122
123
124
126
130
137
138
Question Number
125
127
128
129
131
132
133
134
135
136

Question 121: Were there clinically significant co-existing disease or organ
impairment at the time of patient assessment prior to preparative regimen?
If the recipient has a documented history of clinically significant co-existing
disease(s) or organ impairment(s), check “yes.” The intent of this question is to
identify serious pre-existing conditions that may have an affect on the outcome of
the HSCT. For the purposes of this manual, the term “clinically significant” refers
to conditions that are being treated at the time of pre-HSCT evaluation, or have
affected the recipient’s medical history and may cause complications post-HSCT.
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 HSCT
should not be reported.
Additionally, for the purposes of this manual, the term “at the time of patient
assessment” is defined as the pre-HSCT 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.” If the HSCT is
allogeneic continue with question 141. If the HSCT is autologous continue with
question 159.
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Questions 122-140: Co-existing diseases or organ impairments
For each listed co-existing disease or organ impairment, check “yes,” “no,” or
“not done.”
The “other, specify” category should be used to report co-morbid conditions that
are of similar clinical concern as the other listed options. For example, if a
recipient has a current or prior history of malignancy other than the disease for
which the HSCT is being performed, report this malignancy in the “other, specify”
field. This would include diseases such as a prior leukemia or lymphoma. Any
history of a malignant solid tumor should be reported as “solid tumor, prior.” For
assistance with reporting co-morbid conditions, consult with a transplant
physician.
The physician performing the recipient’s pre-HSCT evaluation may use the HCT
Co-Morbidity Index (HCT-CI) to document co-morbid conditions (see appendix
M).

GVHD Prophylaxis (allogeneic only)
NOTE: Questions 142-158
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 141-158: Was GVHD prophylaxis planned/given?
Following an allogeneic HSCT, 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. Any planned
agent a recipient is scheduled to receive as a result of these protocols should be
included in this section.
The prophylactic drug options listed on the form are intended to be systemic or
oral administration. 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 graft source 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 HSCT, fax or e-mail an explanation to your center’s CIBMTR liaison,
and request it be scanned as part of the form documentation.
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Post-HSCT Disease Therapy Planned as of Day 0
Question 159: Is this HSCT part of a planned multiple (sequential)
graft/HSCT protocol?
If, at the time of the current HSCT, a second (tandem transplant) or subsequent
HSCT is planned according to the protocol, check “yes” even if the recipient does
not receive the planned second HSCT. The word “planned” should not be
interpreted as: if the recipient relapses, then the “plan” is to perform a
subsequent HSCT.
NOTE: Questions 161-170
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 161-170 are optional for non-US centers.
Questions 160-170: Is additional post-HSCT therapy planned?
If additional post-HSCT 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.

Other Toxicity Modifying Regimen
Questions 171-172 are optional for non-US centers.
Question 171: 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.
Question 172: Was FGF (velafermin) started or is there a plan to use it?
Check “yes” if FGF was started or planned. Check “no” if FGF was not started or
planned.
Check “masked trial” if the recipient is part of a FGF study where the agent the
recipient received is not known (e.g., placebo, drug, or other agent). Use the
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error correction process to update the data field once the trial is over and the
agent the recipient was given is known.

Pre-TED Disease Classification Sheet
NOTE: Disease Classification Sheet
The newest version of the TED forms uses the World Health Organization (WHO)
disease classifications. Each Disease Classification Sheet contains all of the
established WHO disease types and subtypes. The “other, specify” category
should only be used 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 liaison, or visit the WHO website at:
http://www.who.int/classifications/icd/en/.
Several of the Disease Classification Sheets 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. 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 liaison.
NOTE: Malignant vs. Non-malignant
Malignant diseases involve cells dividing without control, which 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.
The diseases listed in the following section are malignant.
Question 173: Indicate the primary disease for which the HSCT was
performed
Using the appropriate Disease Classification Sheet, select the detailed disease
classification within the broad disease group for which this HSCT was performed.
If the indication for HSCT is due to a combination of diseases or a transformation
of one disease to another, multiple Disease Classification Sheets may be
required. For examples of common disease combinations and transformations,
see tables 1 and 2.

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Helpful Hint:
The CIBMTR database disease codes are represented in parentheses after the
disease subtype on the Disease Classification Sheet, and can be helpful in
mapping diagnosis, e.g., Myeloid Sarcoma (280).

Acute Leukemias
Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic
Leukemia (ANLL)
Question 174: Select most specific WHO classification for AML
Indicate the disease classification at diagnosis; the older FAB classifications are
shown in brackets, e.g., {M0}.
Question 175: Did AML transform from MDS or MPS?
AML often evolves from MDS or MPS. This transformation is typically
distinguished by the percentage of blasts in the bone marrow. AML that
transforms from MDS or MPS has a lower survival prognosis because of the
association with unfavorable cytogenetic abnormalities.
If AML transformed from MDS or MPS, check “yes” and complete both the AML
and MDS/MPS Disease Classification Sheets.
NOTE: Questions 177-179
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Question 176: Was AML therapy related?
Agents used to treat other diseases can damage the marrow and lead to a
secondary malignancy, such as AML. If the diagnosis of AML is therapy related,
check “yes” and continue with question 177. If the diagnosis of AML is not
therapy related, check “no” and continue with question 180.
Questions 177-179: AML, therapy related
Indicate the therapy associated with the diagnosis of AML.
Question 180: Was imatinib mesylate given for pre-transplant therapy
anytime prior to start of preparative regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B.
Questions 181-185: Status at Transplantation
Indicate the disease status of AML immediately prior to the start of the
preparative regimen.
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Disease Status
Never Treated

Primary Induction
Failure (PIF)

Complete
Remission (CR)*

Definition
The recipient was diagnosed with acute leukemia and never
treated.
For example, this disease status may be appropriate if MDS
was initially diagnosed and treated, the MDS then
transformed into AML, and a decision was made to proceed
immediately to transplant instead of treating the AML with
therapy.
The recipient was treated for acute leukemia, but never
achieved complete remission (CR) with any therapy. PIF is
not limited to the number of treatments used unsuccessfully.
This status only applies to recipients who have never been
in CR.
A treatment response where all of the following criteria are
met for at least four weeks:**
• < 5% blasts in the bone marrow
• Normal maturation of all cellular components in the
bone marrow
• No blasts with Auer rods (AML only)
• No extramedullary disease (e.g., central nervous
system or soft tissue involvement)
• ANC of > 1,000/µL
• Platelets ≥ 100,000/µL
• Transfusion independent
**In some cases, there may not be a four-week interval
between the completion of treatment for disease and the
disease assessment immediately prior to the HSCT. If this is
the case, CR should still be reported as the status at
transplantation. Although this is an exception to the general
condition that CR is “durable” beyond four weeks, the status
of CR represents the “best assessment” prior to HSCT. The
pre-HSCT disease status should not be changed based
on early relapse or disease assessment post-HSCT.
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.
Include recipients with persistent cytogenetic abnormality
who otherwise meet all the criteria of CR. The cytogenetic
abnormality should be reported in the appropriate section
(see question 182).
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Do not include recipients with extramedullary disease. They
should be considered to have persistent disease, or to be in
relapse.
NOTE: 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).
Questions 182-184: For hematologic CR
Hematologic CR includes all the criteria listed for CR above.
For recipients who achieve a hematologic CR, indicate in
questions 182-183 if the response also qualified as a
cytogenetic or molecular remission.
Question 182: Cytogenetic remission
Cytogenetic assessment involves testing blood or bone
marrow for the presence of a known cytogenetic abnormality
that reflects 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 all of
the following criteria are met:
• The karyotype reverts to normal
• There are no clonal chromosomal abnormalities
detected in the blood and/or marrow
Question 183: Molecular remission
Molecular assessment involves determining whether a
molecular marker for the disease exists in the blood or bone
marrow. Molecular assessment is the most sensitive method
of detection, and can indicate known genetic abnormalities.
RFLP testing (with PCR amplification) is an example of a
molecular test method.
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).
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Relapse

Question 184: Number
Indicate the number of this hematologic CR.
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 that,
in the judgment of a physician, are at a level
representing relapse
Question 185: Number
Indicate the number of this relapse using the following
guidelines:
• 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 a partial response (PR) when calculating
the number of relapses. Recipients who achieve a PR to
treatment should be reported as either PIF (if never in CR
previously) or relapse. PR in AML is generally of short
duration and unlikely to predict clinical benefit.

*Sources of disease response definitions:
1) www.uptodate.com
2) www.cancer.gov/help
3) www.jco.ascopubs.org Cheson vol. 21 number 24 pp4642-4649

Acute Lymphoblastic Leukemia (ALL)
Question 186: Specify (disease classification)
Indicate the disease classification at diagnosis; the older FAB classifications are
shown in brackets, e.g., {L2}.
The current WHO disease classification for ALL is divided between precursor Bcell and precursor T-cell. If cytogenetic abnormalities present at diagnosis are
among the other options listed on the Pre-TED form, check the sub-type rather
than precursor B-cell ALL option.
Question 187: Was imatinib mesylate given for pre-transplant therapy
anytime prior to start of prep regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B.

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Questions 188-192: Status at Transplantation
Indicate the disease status of ALL immediately prior to the start of the preparative
regimen.
Disease Status
Never Treated
Primary Induction
Failure (PIF)

Complete
Remission (CR)*

Definition
The recipient was diagnosed with acute leukemia and never
treated.
The recipient was treated for acute leukemia, but never
achieved CR with any therapy. PIF is not limited to the
number of treatments used unsuccessfully. This status only
applies to recipients who have never been in CR.
A treatment response where all of the following criteria are
met 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., central nervous
system or soft tissue involvement)
• ANC of > 1,000/µL
• Platelets ≥ 100,000/µL
• Transfusion independent
**In some cases, there may not be a four-week interval
between the completion of treatment for disease and the
disease assessment immediately prior to the HSCT. If this is
the case, CR should still be reported as the status at
transplantation. Although this is an exception to the general
condition that CR is “durable” beyond four weeks, the status
of CR represents the “best assessment” prior to HSCT. The
pre-HSCT disease status should not be changed based
on early relapse or disease assessment post-HSCT.
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.
Include recipients with persistent cytogenetic abnormality
who otherwise meet all the criteria of CR. The cytogenetic
abnormality should be reported in the appropriate section
(see question 182).
Do not include recipients with extramedullary disease. They
should be considered to have persistent disease, or to be in
relapse.

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Questions 189-191: For hematologic CR
Hematologic CR includes all the criteria listed for CR above.
For recipients who achieve a hematologic CR, indicate in
questions 189-190 if the response also qualified as a
cytogenetic or molecular remission.
Question 189: Cytogenetic remission
Cytogenetic assessment involves testing blood or bone
marrow for the presence of a known cytogenetic abnormality
that reflects 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 all of
the following criteria are met:
• The karyotype reverts to normal
• There are no clonal chromosomal abnormalities
detected in the blood and/or marrow
Question 190: Molecular remission
Molecular assessment involves determining whether a
molecular marker for the disease exists in the blood or bone
marrow. Molecular assessment is the most sensitive method
of detection, and can indicate known genetic abnormalities.
RFLP testing (with PCR amplification) is an example of a
molecular test method.
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).

Relapse

Question 191: Number
Indicate the number of this hematologic CR.
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 that,
in the judgment of a physician, are at a level
representing relapse.

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Question 192: Number
Indicate the number of this relapse using the following
guidelines:
• 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 a partial response (PR) when calculating
the number of relapses. Recipients who achieve a PR to
treatment should be reported as either PIF (if never in CR
previously) or relapse.
*Sources of disease response definitions:
1) www.uptodate.com
2) www.cancer.gov/help
3) www.jco.ascopubs.org Cheson vol. 21 number 24 pp4642-4649

Other Acute Leukemias (Acute leukemias of ambiguous lineage)
Questions 193-194: Specify (disease classification)
Indicate the disease classification at diagnosis. The “other, specify” category
should only be used if the recipient’s disease is not one of the listed options.
• 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 195: Was imatinib mesylate given for pre-transplant therapy
anytime prior to start of prep regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B.
Questions 196-199: Status at Transplantation
Indicate the disease status immediately prior to the start of the preparative
regimen.
Disease Status
Never Treated
Primary Induction
Failure (PIF)

Definition
The recipient was diagnosed with acute leukemia and never
treated.
The recipient was treated for acute leukemia, but never
achieved CR with any therapy. PIF is not limited to the
number of treatments used unsuccessfully. This status only
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Complete
Remission (CR)*

applies to recipients who have never been in CR.
A treatment response where all of the following criteria are
met 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., central nervous
system or soft tissue involvement)
• ANC of > 1,000/µL
• Platelets ≥ 100,000/µL
• Transfusion independent
**In some cases, there may not be a four-week interval
between the completion of treatment for disease and the
disease assessment immediately prior to the HSCT. If this is
the case, CR should still be reported as the status at
transplantation. Although this is an exception to the general
condition that CR is “durable” beyond four weeks, the status
of CR represents the “best assessment” prior to HSCT. The
pre-HSCT disease status should not be changed based
on early relapse or disease assessment post-HSCT.
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.
Include recipients with persistent cytogenetic abnormality
who otherwise meet all the criteria of CR. The cytogenetic
abnormality should be reported in the appropriate section
(see question 182).
Do not include recipients with extramedullary disease. They
should be considered to have persistent disease, or to be in
relapse.
Questions 197-198: For hematologic CR
Hematologic CR includes all the criteria listed for CR above.
For recipients who achieve a hematologic CR, indicate in
questions 197-198 if the response also qualified as a
cytogenetic or molecular remission.
Question 197: Cytogenetic remission
Cytogenetic assessment involves testing blood or bone
marrow for the presence of a known cytogenetic abnormality
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that reflects 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 all of
the following criteria are met:
• The karyotype reverts to normal
• There are no clonal chromosomal abnormalities
detected in the blood and/or marrow
Question 198: Molecular remission
Molecular assessment involves determining whether a
molecular marker for the disease exists in the blood or bone
marrow. Molecular assessment is the most sensitive method
of detection, and can indicate known genetic abnormalities.
RFLP testing (with PCR amplification) is an example of a
molecular test method.
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).

Relapse

Question 199: Number
Indicate the number of this hematologic CR.
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 that,
in the judgment of a physician, are at a level
representing relapse.
Question 200: Number
Indicate the number of this relapse using the following
guidelines:
• 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 a partial response (PR) when calculating
the number of relapses. Recipients who achieve a PR to
treatment should be reported as either PIF (if never in CR
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previously) or relapse.
*Sources of disease response definitions:
1) www.uptodate.com
2) www.cancer.gov/help
3) www.jco.ascopubs.org Cheson vol. 21 number 24 pp4642-4649

Chronic Myelogenous Leukemia (CML)
Question 201: Philadelphia chromosome+, Ph+, t(9;22)(q34;q11), or variant
OR bcr/abl+
Indicate the 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 3 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, submit the
Disease Classification sheet for “Other Leukemias” and report “Atypical chronic
myeloid leukemia” as the detailed disease classification (questions 262-264).
Table 3. CML Classification Requirements
Term
Definition
An exchange of genetic material
Philadelphia chromosome
between region q34 of chromosome 9
t(9;22)(q34;q11)
and region q11 of chromosome 22.
Translocation of three or more
Complex variation
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
Variant form
suspected diagnosis [e.g., t(13;
22)(p3;q11)].
NOTE: Questions 202-210
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Question 202: Did recipient receive treatment prior to this HSCT?
If the recipient received therapy to treat CML prior to this HSCT, check “yes” and
continue with question 203. If the recipient did not receive therapy to treat CML,
check “no” and continue with question 211.

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Questions 203-210: CML treatment
Indicate the therapy the recipient received to treat CML prior to this HSCT. 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 211-216: Status at Transplantation – Phase
Indicate the recipient’s disease phase immediately prior to the start of the
preparative regimen.
Disease
Response: Phase
Hematologic CR

Definition
A treatment response where all of the following criteria are
met:
• White blood count is less than 10 x 109/L, without
immature granulocytes and with less than 5%
basophils
• Platelet count less than 450 x 109/L
• Non-palpable spleen
NOTE:
Question 212 is optional for non-U.S. transplant centers.
Question 212: 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 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)
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• 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
• Blast Phase: Characterized by ≥ 20% blasts (formerly
≥ 30%) in the peripheral blood or bone marrow.
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).
Questions 213-214: Indicate if the response also qualified
as a cytogenetic or molecular remission.
Question 213: Cytogenetic remission
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%
For purposes of reporting disease status, a “major”
cytogenetic response includes any partial or complete
response (Ph+ < 35%).
Question 214: Molecular remission
PCR testing reveals no molecular evidence of the BCR-ABL
fusion gene in the blood (e.g., BCR-ABL transcript is nondetectable and non-quantifiable in an assay that has at least
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Chronic Phase

4-5 log range of detection).
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.
Questions 215 -216: Indicate if the response also qualified
as a cytogenetic or molecular remission.
Question 215: Cytogenetic remission
Cytogenetic response is determined by either conventional
or FISH cytogenetics for the Ph 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%
For purposes of reporting disease status, a “major”
cytogenetic response includes any partial or complete
response (Ph+ < 35%)

Accelerated
Phase*

Blast Crisis

Question 216: Molecular remission
PCR testing reveals no molecular evidence of the BCR-ABL
fusion gene in the blood (e.g., BCR-ABL transcript is nondetectable and non-quantifiable in an assay that has at least
4-5 log range of detection).
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
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
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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 (socalled lymphoid blast crisis or myeloid blast crisis).
*Source of disease response definition: WHO definition as listed on the CIBMTR Pre-HSCT CML
Disease Form 2012

Question 217: Status at Transplantation – Number
Indicate the number of the disease phase reported in question 211.

Myelodysplastic or Myeloproliferative Diseases
NOTE: MDS
If the recipient is being transplanted for AML that has transformed from MDS, the
primary disease for HSCT must be reported as AML. Disease Classification
Sheets must be completed for both AML and MDS.

MDS or Myeloproliferative Diseases
NOTE: Questions 218-250
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check the most specific WHO classification.
Questions 218-250: Classification
MDS and MPS contain a range of disorders that may transform from one subtype
to another during the course of the disease. Therefore, indicate the recipient’s
disease classification both at diagnosis and immediately prior to the start of the
preparative regimen.
If MDS or MPS transformed to AML, continue to question 251, and complete both
the MDS and the AML Disease Classification Sheets.
Question 251: If AML, date of MDS diagnosis
If MDS transformed into AML between initial diagnosis and the start of the
preparative regimen, enter the MDS diagnosis date. (Report the AML diagnosis
date in question 1.)
If the source documentation does not include the exact pathological diagnosis
date of the MDS/MPS, enter the AML diagnosis date in this field.

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NOTE:
Question 252 should only be answered if the recipient is being transplanted for a
chronic myeloproliferative disease (MPS).
Question 252: Was Janus kinase 2 (JAK2) gene mutation positive?
The JAK2 pathway is responsible for activation of proteins that are involved in
the development and function of the immune system, and that also play a role in
maintaining immune tolerance and tumor surveillance. JAK2 disruption has been
associated with a variety of myeloproliferative disorders due to resulting
immunosuppression and enhanced survival of tumors.
Questions 253: Was MDS/MPS therapy related?
Agents used to treat other diseases can damage the bone marrow and lead to
MDS/MPS.
If the diagnosis of MDS/MPS is therapy related, check “yes” and continue with
question 254.
If the diagnosis of MDS/MPS is not therapy related, check “no” and continue with
question 257.
Questions 254-256: MDS, therapy related
Indicate the therapy associated with the diagnosis of MDS/MPS.

MDS/MPS/CMML
Questions 257-260: Status at Transplantation
Indicate the disease status of MDS/MPS/CMML immediately prior to the start of
the preparative regimen.
Disease Status
Supportive care or
treatment without
chemotherapy

Treated with
chemotherapy*

Definition
Examples of this status include but are not limited to:
• Observation with periodic blood count tests (also
known as “watch and wait”)
• Blood transfusions and iron chelation therapy
• Administration of erythropoietin (EPO) and other
blood cell growth factors
• Therapy with antithymocyte globulin (ATG)
• Immune modulation agents including thalidomide
and lenalidomide
Examples of this status include but are not limited to:
• Low intensity chemotherapy including cytarabine,
azacitidine (Vidaza®), and decitabine (Dacogen®)
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• High intensity chemotherapy that may include
aggressive antileukemic therapy such as a
combination of cytarabine and idarubicin
Question 258: Status at Transplantation, specify
From the options listed below, indicate the recipient’s
disease status immediately prior to the start of the
preparative regimen.
Complete Remission (CR): A treatment response
where all of the following criteria are met and
maintained for ≥ 4 weeks:
• Bone marrow evaluation:
− < 5% myeloblasts with normal maturation of
all cell lines
• Peripheral blood evaluation:
− hemoglobin ≥ 11 g/dL untransfused and
without erythropoietin support
− ANC ≥ 1000/mm3 without myeloid growth
factor support
− platelets ≥ 100 x 109/L without
thrombopoietic support
− 0% blasts
If the timeframe between achieving CR and the
start date of the HSCT (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,
then an Error Correction Form must be submitted
changing the pre-HSCT status.
Question 259: Number
Indicate the number of this CR.
Improvement, but no CR: A treatment response
where one or more of the following criteria are met
and maintained for ≥ 8 weeks without ongoing
cytotoxic therapy:
• Hematologic Improvement (HI)-E
− Hemoglobin increase of ≥ 1.5 g/dL
untransfused
− For RBC transfusions performed for Hgb
≤ 9.0, reduction in RBC units transfused in
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treatment transfusion number in the
previous 8 weeks
• HI-P
− For pre-treatment platelet count of > 20 x
109/L/L, platelet absolute increase of ≥ 30 x
109/L/L
− For pre-treatment platelet count of < 20 x
109/L/L, platelet absolute increase of ≥ 20 x
109/L /L and ≥ 100% from pre-treatment
level
• HI-N
− Neutrophil count increase of ≥ 100% from
pre-treatment level and an absolute
increase of ≥ 500/mm3
NR – no response: A treatment response that does
not meet the criteria for the “improvement, but not CR”
category, and no evidence of disease progression.
Progressive/Worse: A treatment response where one
or more of the following criteria are met 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
Relapsed after CR* A treatment response where one or more or the following
criteria are met:
• Return to pre-treatment bone marrow blast
percentage
• Decrease of ≥ 50% from maximum response levels
in granulocytes or platelets
• Transfusion dependence or hemoglobin level ≥
1.5g/dL lower than prior to therapy
Question 260: Number
Indicate the number of this relapse using the following
guidelines:
• 1st relapse: one prior complete remission
• 2nd relapse: two prior complete remissions
• 3rd or higher: three or more complete remissions
followed by relapse
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Do not include PRs when calculating the number of
relapses.
*Source of disease response definition: CIBMTR Pre-HSCT MDS/MPS Disease Form 2014

JMML
Question 261: Status at Transplantation
Indicate the recipient’s disease status of JMML immediately prior to the start of
the preparative regimen.
Disease Status
Continued
Complete
Response (CCR)*
Complete
Response (CR)*
Partial Response
(PR)*
Minimal Response
(MR)*

Stable Disease
(SD)*
Progressive
Disease (PD)*
Not Assessed*

Definition
Recipient achieved CR and has remained in CR. Continued
absence of all known disease after achieving CR following a
previous line of therapy.
Characterized by normalization of WBC and organomegaly.
Less than or equal to a 50% reduction in WBC and/or
organomegaly.
Requires one or more of the following:
• Between 25% and 50% reduction in WBC and
organomegaly
• Partial response in WBC but no change in
organomegaly
• Partial response in organomegaly but no change in
WBC
Less than or equal to a 25% reduction in WBC and/or
organomegaly.
Characterized by an increase in WBC and/or organomegaly.
No assessment of the recipient’s disease has been done.
This option should rarely be used.

*Source of disease response definition: CIBMTR Pre-HSCT JMML/JCML Disease Form 2015

Other Leukemias
Questions 262-263: Classification
Indicate the disease classification at diagnosis. The “other, specify” category
should only be used if the recipient’s disease is not one of the listed options.
Question 264: Status at Transplantation
Each disease classification has different criteria for disease status. Use the
disease-specific criteria listed in the tables below to determine the recipient’s
disease status immediately prior to the start of the preparative regimen.
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• Atypical CML is a chronic myeloproliferative disorder that is similar to
chronic myelogenous leukemia (CML). The criteria for atypical CML
include, but are not limited to, lack of Philadelphia chromosome and
bcr/abl or PDGFR-beta rearrangements; 10%-20% immature
granulocytes; significant granulocytic dysplasia; less than 2% basophils
and less than 10% monocytes.
Disease Status
Never Treated
Complete Remission
(CR)

Definition
The recipient was diagnosed with atypical
CML and never treated.
All of the following criteria are met and
maintained for ≥ 4 weeks:
• 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 HSCT (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, then an Error
Correction Form must be submitted to
change the pre-HSCT status.
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.
Include recipients with persistent
cytogenetic abnormality who otherwise
meet all the criteria of CR. The cytogenetic
abnormality should be reported in the
appropriate section (see question 182).

Nodular Partial
Remission (nPR)

Do not include recipients with
extramedullary disease. They should be
considered to have persistent disease, or
to be in relapse.
Not applicable.
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Partial Remission
(PR)
No Response/Stable
Disease (NR/SD)

Progression
Relapse (untreated)

Not applicable.
The recipient was treated for acute
leukemia, but never achieved CR with
any therapy. PIF is not limited to the
number of treatments used unsuccessfully.
This status only applies to recipients who
have never been in CR.
Not applicable.
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 a level representing
relapse as determined by a
physician.

• CLL is known as either chronic lymphocyctic leukemia or chronic
lymphoblastic leukemia, and is characterized by an increased number
of lymphoblasts in the blood and bone marrow.
Disease Status
Never Treated
Complete Remission
(CR)*

Nodular Partial
Remission (nPR)*
Partial Remission
(PR)*

Definition
The recipient was diagnosed with leukemia
and never treated.
Requires all the following:
• No lymphadenopathy
• No organomegaly
9
• Neutrophils > 1.5 x 10 /L
9
• Platelets > 100 x 10 /L
• Hemoglobin 11g/dL
9
• Lymphocytes < 4 x 10 /L/L
• Bone marrow < 30% lymphocytes
• Absence of constitutional symptoms
Complete response with persistent
lymphoid nodules in bone marrow.
Requires all of the following:
• 50% decrease in peripheral blood
lymphocyte count from pretreatment
value
• 50% reduction in lymphadenopathy if
present pretreatment
• 50% reduction in liver and spleen size
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if enlarged pretreatment

No Response/Stable
Disease (NR/SD)*
Progression*

Relapse (untreated)

AND one or more of the following:
9
• Neutrophils ≥ 2.5x10 /L or 50% above
baseline
9
• Platelets > 100x10 /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.

*Source of disease response definition: CIBMTR Pre-HSCT CLL Disease Form
2013

• Hairy cell leukemia is characterized by the presence of abnormal Blymphocytes in the bone marrow, peripheral blood, and spleen.
Disease Status
Never Treated
Complete Remission
(CR)*

Nodular Partial
Remission (nPR)

Definition
The recipient was diagnosed with hairy cell
leukemia and never treated.
Disappearance of all evidence of disease.
Requires all of the following:
9
• Neutrophils ≥ 1.5 x 10
• Hemoglobin ≥ 12.0 g/dL
9
• Platelets ≥ 100 x 10 /L
• Absence of hairy cells on peripheral
blood smear
• No palpable lymphadenopathy or
hepatosplenomegaly
Not applicable
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Partial Remission
(PR)*

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
Not applicable
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
classified as partial responders based
on residual splenomegaly only

*Source of disease response definition:
http://bloodjournal.hematologylibrary.org/cgi/content/full/92/6/1918

• PLL, or prolymphocytic leukemia, is a type of CLL and is characterized
by an increased presence of immature prolymphocytes in the bone
marrow and peripheral blood.
Disease Status
Never Treated
Complete Remission
(CR)*

Definition
The recipient was diagnosed with leukemia
and never treated.
Requires all the following:
• No lymphadenopathy
• No organomegaly
9
• Neutrophils > 1.5 x 10 /L
9
• Platelets > 100 x 10 /L
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Hemoglobin > 11g/dL
9
• Lymphocytes < 4 x 10 /L/L
• Bone marrow < 30% lymphocytes
• Absence of constitutional symptoms
Complete response with persistent
lymphoid nodules in bone marrow.
Requires all of the following:
• 50% decrease in peripheral blood
lymphocyte count from pretreatment
value
• 50% reduction in lymphadenopathy if
present pretreatment
• 50% reduction in liver and spleen size
if enlarged pretreatment
•

Nodular Partial
Remission (nPR)*
Partial Remission
(PR)*

No Response/Stable
Disease (NR/SD)*
Progression*

Relapse (untreated)

AND one or more of the following:
9
• Neutrophils ≥ 2.5x10 /L or 50% above
baseline
9
• Platelets > 100x10 /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.

*Source of disease response definition: CIBMTR Pre-HSCT CLL Disease Form
2013

• Other: This category should be used only if the recipient’s disease
does not fit one of the other leukemia options listed. 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 liaison.
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Lymphomas
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.
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 Sheet 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 Sheet for
Lymphomas, and report HL as a prior malignancy in the “other, specify”
field in the co-morbid condition section (questions 139-140).
Scenario 2: A recipient is being transplanted for both active NHL and
active HL. Complete the Disease Classification Sheet for “Other” Disease
(code 900). Do not complete the Disease Classification Sheet for
Lymphomas.

Hodgkin Lymphoma
Question 265: Specify disease type
Indicate the disease classification at diagnosis.
Question 266: Status at Transplantation
Indicate the recipient’s disease status immediately prior to the start of the
preparative regimen.

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Disease Status
Never Treated

Definition
The recipient was diagnosed with lymphoma and never
treated.
Primary Refractory The response of the lymphoma to treatment is less than in a
partial response (PR). This status would also include
(less than PR to
initial therapy)/PIF recipients who achieved a prior PR (but never CR) but are
not in either PR or relapse immediately prior to transplant.
res
Reductions of ≥ 50% in greatest diameter of all sites of
Partial Response
known disease and no new sites.
(PR)*

CR Confirmed*

Question 267: Specify
Partial response may be represented as PR1, PR2, etc.
There are differing interpretations of what the number after
“PR” represents. To avoid confusion, distinguish the type of
PR with the following: “without prior CR” and “with prior CR”,
as that is what is important in CIBMTR analysis.
Complete disappearance of all known disease for ≥ 4 weeks.
Question 268: Number
Indicate the number of this CR.

CR Unconfirmed
(CRU)*

For the purposes of this manual, the term “confirmed” is
defined as a laboratory and/or pathological radiographic
determination. The term “unconfirmed” is defined as scan
abnormalities of unknown significance that are not biopsied
or otherwise evaluated.
Complete disappearance of all known disease for ≥ 4 weeks
with the exception of persistent scan abnormalities of
unknown significance.
Question 268: Number
Indicate the number of this CR.

Relapse (Rel)

For the purposes of this manual, the term “confirmed” is
defined as a laboratory and/or pathological radiographic
determination. The term “unconfirmed” is defined as scan
abnormalities of unknown significance that are not biopsied
or otherwise evaluated.
Recurrence of disease after CR. This may involve an
increase in size of known disease or new sites of disease.
Question 269: Number
Indicate the number of this relapse using the following
guidelines:
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• 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.
Question 270: Sensitivity to Chemotherapy:*
Sensitivity is measured based on the last chemotherapy
given within the six months prior to HSCT. Indicate the
recipient’s sensitivity to chemotherapy using the following
guidelines:
• Sensitive = ≥ 50% reduction in the bi-dimensional
diameter of all disease sites with no new sites of
disease (PIF sen, PR1, CR, CRU, REL sen)
• Resistant = < 50% reduction in the diameter of all
disease sites or development of new disease sites
(PIF sen, REL res)
• Untreated = No chemotherapy was given within the
6 months prior to the preparative regimen (disease
untreated, REL unt)
• Unknown (PIF unk, REL unk)
*Source of disease response definition: CIBMTR Pre-HSCT Lymphoma Disease Form 2018

Non-Hodgkin Lymphoma
Question 271: Specify disease type
Indicate the disease classification at diagnosis.
If Follicular NHL is reported, for paper form submission, indicate the grade at
diagnosis. In the FormsNet™2 application, select the appropriate grade at
diagnosis.
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 1.
Question 272: Diffuse large B-cell lymphoma – If known, indicate subtype
If the recipient has a diagnosis of diffuse large B-cell lymphoma, indicate the
subtype. If the subtype is unknown, write “unknown” on the paper form, or
override the question with the “unknown” override option in FormsNetTM2.
Question 273: Other B-cell lymphoma, specify
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This category should be used only if the recipient’s disease does not fit one of
the other B-cell options listed.
Question 274: Other T/NK cell lymphoma, specify
This category should be used only if the recipient’s disease does not fit one of
the other T/NK cell options listed.
Question 275: Status at Transplantation
Indicate the recipient’s disease status immediately prior to the start of the
preparative regimen.
Disease Status
Never Treated

Definition
The recipient was diagnosed with lymphoma and never
treated.
Primary Refractory The response of the lymphoma to treatment is less than in a
partial response (PR). This status would also include
(less than PR to
initial therapy)/PIF recipients who achieved a prior PR (but never CR) but are
not in either PR or relapse immediately prior to transplant.
res
Reductions of ≥ 50% in greatest diameter of all sites of
Partial Response
known disease and no new sites.
(PR)*

CR Confirmed*

Question 276: Specify
Partial response may be represented as PR1, PR2, etc.
There are differing interpretations of what the number after
“PR” represents, and this can be confusing.
What is important to CIBMTR data analysis is to distinguish
the type of PR as either: “without prior CR” or “with prior
CR.”
Complete disappearance of all known disease for greater
than or equal to four weeks.
Question 277: Number
Indicate the number of this CR.

CR Unconfirmed
(CRU)*

For the purposes of this manual, the term “confirmed” is
defined as a laboratory and/or pathological radiographic
determination. The term “unconfirmed” is defined as scan
abnormalities of unknown significance that are not biopsied
or otherwise evaluated.
Complete disappearance of all known disease for ≥ 4 weeks
with the exception of persistent scan abnormalities of
unknown significance.*
Question 277: Number
Indicate the number of this CR.
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Relapse (Rel)

For the purposes of this manual, the term “confirmed” is
defined as a laboratory and/or pathological radiographic
determination. The term “unconfirmed” is defined as scan
abnormalities of unknown significance that are not biopsied
or otherwise evaluated.
Recurrence of disease after CR. This may involve an
increase in size of known disease or new sites of disease.
Question 278: Number
Indicate the number of this relapse using the following
guidelines:
• 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.
Question 279: Sensitivity to Chemotherapy:*
Sensitivity is measured based on the last chemotherapy
given within the six months prior to HSCT. Indicate the
recipient’s sensitivity to chemotherapy using the following
guidelines:
• Sensitive = ≥ 50% reduction in the bi-dimensional
diameter of all disease sites with no new sites of
disease (PIF sen, PR1, CR, CRU, REL sen)
• Resistant = < 50% reduction in the diameter of all
disease sites or development of new disease sites
(PIF sen, REL res)
• Untreated = No chemotherapy was given within the
6 months prior to the preparative regimen (disease
untreated, REL unt)
• Unknown (PIF unk, REL unk)

*Source of disease response definitions: CIBMTR Pre-HSCT Lymphoma Disease Form 2018

Plasma Cell Disorders
The role of plasma cells is to produce and release immunoglobulins (or
antibodies) to attack and destroy disease-causing bacteria and viruses.
Immunoglobulins typically contain two large heavy chains and two small light
chains. There are five types of immunoglobulin heavy chains: IgG, IgA, IgD, IgE,
and IgM, and there are two types of light chains: lambda and kappa.
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Abnormal plasma cells often produce tumors in the bone marrow. A single
plasma cell tumor is referred to as a plasmacytoma. Tumors that spread
throughout the bone marrow are referred to as myeloma or multiple myeloma.
Symptoms of plasma cell disorders (PCD) include, but are not limited to: bone
pain and fractures, anemia, decreased immunity to infection, kidney dysfunction,
muscle weakness, malaise and fatigue, and mental confusion.
Question 280: Classification
Indicate the disease classification at diagnosis.
If the recipient’s disease classification is one of the following, continue with
question 281.
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 7, multiple myeloma - non-secretory,
neither kappa nor lambda light chains will be present; therefore, continue with
question 282 (Durie-Salmon) or question 284 (I.S.S.).
Question 281: Light Chain
Indicate the presence of light chains as either kappa or lambda.
NOTE: Questions 282-286, stage at diagnosis
Report the recipient’s stage at diagnosis using either the Durie-Salmon staging
system (questions 282-283) or the International Staging System (I.S.S.)
(questions 284-286).
Questions 282-283: Stage at Diagnosis: Durie-Salmon
Indicate stage and sub-classification.
Questions 284-286: Stage at Diagnosis: I.S.S.
Report the recipient’s lab values from diagnosis and/or the stage of myeloma.
Question 287: Other Plasma Cell Disorder, specify
On occasion, a recipient could have two heavy-chain types. In this instance
report “other plasma cell disorder” and specify the appropriate types.
In situations of tandem autologous HSCT, oligoclonal reconstitution from a
previous HSCT should not be reported as a new subtype. For questions
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regarding oligoclonal reconstitution, contact your transplant center’s CIBMTR
liaison.
For recipients diagnosed with more than one PCD, either sequentially or
concurrently, see table 4 below.
Table 4. Plasma Cell Disorders: Disease Combinations
Disease Combination

Required disease
classification sheet:

Plasmacytoma
transformed to Myeloma
Myeloma and Plasma
Cell Leukemia
Myeloma and
Amyloidosis

Myeloma

Report the disease
diagnosis date of
(question 1):
Myeloma

Plasma Cell Leukemia

Plasma Cell Leukemia

Myeloma

Myeloma

Question 288: Status at Transplant
Indicate the recipient’s disease status immediately prior to the start of the
preparative regimen.
Disease Status
Never Treated*
Complete
Remission (CR)*

Definition
No treatment given in the six months prior to HSCT.
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)
CR requires two consecutive assessments made at any time
before the institution of any new therapy, and no known
evidence of progressive or new bone lesions if radiographic
studies were performed; radiographic studies are not
required to satisfy CR requirements.

Stringent
Complete
Remission (sCR)*

Question 289: Number
Indicate the number of this CR.
Follow criteria for CR as defined above, plus all of the
following:
• Normal free light chain ratio,
• Absence of clonal cells in the bone marrow by
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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 made at any
time before the institution of any new therapy, and no known
evidence of progressive or new bone lesions if radiographic
studies were performed; radiographic studies are not
required to satisfy sCR requirements.

Very Good Partial
Response (VGPR)*

Question 289: Number
Indicate the number of this sCR.
One or more of the following must be present:
• Serum and urine M-protein detectable by
immunofixation but not on electrophoresis
• ≥ 90% reduction in serum M-protein and urine Mprotein level < 100 mg/24 hours.
VGPR requires two consecutive assessments made at any
time before the institution of any new therapy, and no known
evidence of progressive or new bone lesions if radiographic
studies were performed; radiographic studies are not
required to satisfy VGPR requirements.

Partial Response
(PR)*

Question 289: Number
Indicate the number of this VGPR.
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 any of the following criteria:
• Serum M-protein ≥ 1 g/dL
• Urine M-protein ≥ 200 mg/24 hours
• Serum-free light chain assay shows involved level ≥
10 mg/dL, provided serum-free light chain ratio is
abnormal) A ≥ 50% decrease in the difference
between involved and uninvolved free light chain
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levels is required in place of the M-protein criteria. If
serum and urine M-protein are not measurable, and
serum-free light assay is also not measurable, a
≥50% reduction in 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, a ≥ 50% reduction in the
size of soft tissue plasmacytomas is also required,
if present at baseline.
PR requires two consecutive assessments made at any time
before the institution of any new therapy, and no known
evidence of progressive or new bone lesions if radiographic
studies were performed; radiographic studies are not
required to satisfy PR requirements.
If there is no documented marrow with <5% plasma cells,
status must be classified as PR.

Stable Disease
(SD)*

Progression*

Question 289: Number
Indicate the number of this PR.
Does not meet the criteria for CR, VGPR, PR, or PD.
SD requires two consecutive assessments made at any time
before the institution of any new therapy, and no known
evidence of progressive or new bone lesions if radiographic
studies were performed; radiographic studies are not
required to satisfy SD requirements.
Requires one or more of the following:
Increase of ≥ 25% from baseline in:
• Serum M-component and/or (absolute increase ≥
0.5 g/dL) (for progressive disease, serum Mcomponent increases of ≥ 1 g/dL are sufficient to
define relapse if the starting M-component is ≥ 5
g/dL)
• Urine M-component and/or (absolute increase ≥
200 mg/24 hours)
• For recipients without measurable serum and urine
M-protein levels: the difference between involved
and uninvolved free light chain levels (absolute
increase > 10 mg/dL)
• Bone marrow plasma cell percentage with absolute
percentage ≥ 10% (relapse from CR has a 5%
cutoff vs. 10% for other categories of relapse)
• Definite development of new bone lesions or soft
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tissue plasmacytomas, or definite increase in the
size of any existing bone lesions or soft tissue
plasmacytomas
• 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
PR requires two consecutive assessments made at any time
before classification as disease progression, and/or the
institution of any new therapy.

Relapse from CR
(untreated)*

Question 289: Number
Indicate the number of this progression.
Requires one or more of the following:
• Reappearance of serum or urine M-protein by
immunofixation or electrophoresis
• Development of ≥ 5% plasma cells in the bone
marrow (relapse from CR has a 5% cutoff vs. 10%
for other categories of relapse)
• Appearance of any other sign of progression (e.g.,
new plasmacytoma, lytic bone lesion,
hypercalcemia)
Relapse requires two consecutive assessments made at any
time before classification as relapse, and/or the institution of
any new therapy.
Question 289: Number
Indicate the number of this relapse.

*Source of disease response definitions: CIBMTR Pre-HSCT Multiple Myeloma/Plasma Cell
Leukemia Disease Form 2016

Breast Cancer
Question 290: Classification
Indicate the disease classification at diagnosis as either “inflammatory” or “noninflammatory.”
Inflammatory breast caner is characterized by a red and swollen appearance.
The skin of the breast may also feel warm to the touch and show a pitted
appearance known as peau d’orange (i.e., orange peel).

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NOTE: Question 291
If the recipient is considered stage IV, select stage III for question 291, and select
“metastatic” for question 292.
Question 291: Stage at Diagnosis
Indicate the recipient’s disease stage (stage I-IV) at diagnosis. Cancer stage is
based on the size of the tumor, whether the cancer is invasive or non-invasive,
whether lymph nodes are involved, and whether the cancer has spread beyond
the breast.
The most common system used to describe the stages of breast cancer is the
American Joint Committee on Cancer (AJCC) TNM system. The letter T refers to
Primary Tumor, N refers to Lymph Node, and M refers to Distant Metastasis.
The additional letters or numbers appearing after T, N, and M provide more
details about the tumor, lymph nodes, and metastasis:
• The letter T followed by a number from 0 to 4 describes the tumor's size
and spread to the skin or to the chest wall under the breast. Higher T
numbers indicate a larger tumor and/or wider spread to tissues near the
breast.
• The letter N followed by a number from 0 to 3 indicates whether the
cancer has spread to lymph nodes near the breast and, if so, how many
lymph nodes are affected.
The letter M followed by a 0 or 1 indicates whether the cancer has spread to
distant organs—for example, the lungs or bones.
Stage
0

I

II

Definition
Carcinoma in situ.
• Lobular carcinoma in situ (LCIS): Abnormal cells
are in the lining of a lobule
• Ductal carcinoma in situ (DCIS): Abnormal cells are
in the lining of a duct. DCIS is also called intraductal
carcinoma
The tumor is no more than 2 cm (¾ inch) across, and the
cancer cells have not spread beyond the breast (T1, N0,
M0).
One of the following criteria must be met:
• The tumor is no more than 2 cm (¾ inch) across. The
cancer has spread to the lymph nodes under the arm
(T1, N1, M0).
• The tumor is between 2 cm and 5 cm (¾ inch and 2
inches). The cancer has not spread to the lymph
nodes under the arm (T2, N0, M0).
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III

• The tumor is between 2 cm and 5 cm (¾ inch and 2
inches). The cancer has spread to the lymph nodes
under the arm (T2, N1, M0).
• The tumor is larger than 5 cm (2 inches). The cancer
has not spread to the lymph nodes under the arm (T3,
N0, M0).
Locally advanced cancer. Stage III is generally divided into
Stage IIIA, IIIB, and IIIC.
Note:
The Pre-TED does not collect the detail of stage III.
Stage IIIA - One of the following criteria must be met:
• The tumor is no more than 5 cm (2 inches) across.
The cancer has spread to underarm lymph nodes that
are attached to each other or to other structures. Or
the cancer may have spread to lymph nodes behind
the breastbone (T0-2, N2, M0).
• The tumor is more than 5 cm across. The cancer has
spread to underarm lymph nodes that are either
alone, attached to each other, or attached to other
structures. Or the cancer may have spread to lymph
nodes behind the breastbone (T3, N1-2, M0).
Stage IIIB - A tumor of any size has grown into the chest
wall or the skin of the breast. It may be associated with
swelling of the breast or with nodules (lumps) in the breast
skin (T4, N0-2, M0).
• The cancer may have spread to lymph nodes under
the arm.
• The cancer may have spread to underarm lymph
nodes that are attached to each other or other
structures. Or the cancer may have spread to lymph
nodes behind the breastbone.
• Inflammatory breast cancer is a rare type of breast
cancer. The breast looks red and swollen because
cancer cells block the lymph vessels in the skin of the
breast. When a doctor diagnoses inflammatory breast
cancer, it is at least Stage IIIB, but it could be more
advanced.
Stage IIIC - A tumor of any size has spread in one of the
following ways (T0-4, N3, M0):
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• The cancer has spread to the lymph nodes behind the
breastbone and under the arm.
• The cancer has spread to the lymph nodes above or
below the collarbone.
Distant metastatic cancer. The cancer has spread to other
parts of the body (including the ipsilateral supraclavicular
lymph nodes).

IV

Question 292: Metastases
Indicate whether the recipient’s disease has metastasized beyond the breast
and/or lymph nodes. Metastatic disease (M1) confirms that the disease has
spread to the distant organs and is considered stage IV.
Question 293: Status at Transplant
Indicate the recipient’s disease status immediately prior to the start of the
preparative regimen.
Disease Status
Adjuvant
(Stage II, III only)

Definition
Adjuvant therapy uses chemotherapy drugs, radiation,
hormone therapy, targeted therapy, or a combination of
these to help destroy any cancer cells that were not removed
during the breast cancer operation. Its goal is to decrease
the risk of the breast cancer coming back.
Never treated indicates the recipient was not treated for
Never Treated
breast cancer (including surgery such as lumpectomy or
mastectomy) prior to the start of the preparative regimen.
This disease status at transplant should be chosen rarely.
Primary Refractory The response of the breast cancer to treatment is less than
in a PR. This status would also include recipients who had
achieved a prior PR (but never CR) but are not in either PR
or relapse immediately prior to transplant.
CR Confirmed: Disappearance of target lesions for a period
Complete
of at least one month.
Remission*
CR Unconfirmed: Complete response with persistent
imaging abnormalities of unknown significance.
Note: Question 294
For the purposes of this manual, the term “confirmed”
is defined as a laboratory and/or pathological
radiographic determination. The term “unconfirmed”
is defined as scan abnormalities of unknown
significance that are not biopsied or otherwise
evaluated.
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Question 294: CR, specify
Using the definitions listed above, indicate whether the CR
was “confirmed” or “unconfirmed.”
Question 295: CR, number
Indicate the number of this response.
1st Partial
Response*

At least 30% decrease in the sum of the longest diameter of
measured lesions (target lesions), taking as reference the
baseline sum of longest distance.
Note: 1st Partial Response
For CIBMTR reporting purposes, this response is
reserved for recipients who have never achieved CR,
but a PR was achieved and maintained at the time of
the preparative regimen.

Relapse

Recurrence of the disease after CR. Can be local or
metastatic.
Question 296: Relapse, specify
Using the definitions below, indicate whether the relapse is
“local” or “metastatic.”
Local: Recurrence occurred in the same side breast or local
lymph nodes.
Metastatic: Recurrence occurred anywhere in the body
other than the same side breast or local lymph nodes.
Question 297: Relapse, number
Using the guidelines below, indicate the number of this
relapse.
• 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.
Question 298: Relapse, sensitivity to chemotherapy*
Sensitivity is measured based on the last chemotherapy
given prior to HSCT; chemotherapy must include ≥ 2 cycles
of treatment given ≤ 6 months prior to HSCT. Indicate the
sensitivity to chemotherapy using the following guidelines:
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• Sensitivity is defined as ≥ 50% reduction in bidimensional diameter of all disease sites with no
new sites of disease.
• Resistant is defined as < 50% reduction in diameter
of all disease sites or development of new disease
sites.
• Untreated should be reported only if the last
treatment was not chemotherapy.
• Unknown should be reported only if there no
documentation of the recipient’s response following
treatment.
*Source of disease response definitions: CIBMTR Pre-HSCT Breast Cancer Disease Form 2020

“Other” Disease
Question 299: Specify
Before using this category, check with a transplant physician to determine
whether the disease can be classified as one of the listed options on the Disease
Classification Sheets.
Question 300: For any “other” disease: Is a pathology report attached to
this form?
Indicate if a pathology report is attached. Attaching a pathology report will help
the CIBMTR confirm reported data and reduce data queries. Attach a copy of the
pathology report using the Log of Appended Document (Form 2800).
Questions 301-302: Alternative HCT:
Report the indication for this HSCT.

Other Malignancies
NOTE: Sarcoma
The names of the sarcoma subtypes have changed with the revised Pre-TED
form. If the sarcoma subtype documented in the recipient’s medical record is not
one of the listed options, consult with a transplant physician as the name of the
subtype may have changed.
Questions 303-304: Classification
Most of the malignancies listed in this section are solid tumors. 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. If a certain disease becomes a common indication for
HSCT, the CIBMTR will add the disease as a separate category.
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Question 305: Status at Transplantation
Indicate the recipient’s disease status immediately prior to the start of the
preparative regimen.
Disease Status
Adjuvant

Never Treated

Complete Response
(CR)

Complete Response
Unconfirmed (CRU)

Partial Response (PR)

WHO Definition
Treatment given after the
primary cancer treatment
to increase the chances
of a cure. Adjuvant
cancer therapy may
include chemotherapy,
radiation therapy,
hormone therapy, or
biological therapy.
Never treated indicates
the recipient was not
treated for the
malignancy prior to the
start of the preparative
regimen. This disease
status at transplant
should rarely be used.
Complete disappearance
of all known disease for ≥
1 month. Includes
disappearance of all
signs and symptoms of
disease with
normalization of all
biochemical and
radiologic parameters, as
well as a negative repeat
biopsy.
Disappearance of all
signs and symptoms of
disease with
normalization of all
biochemical and
radiologic parameters,
but with persistent,
unchanging imaging
abnormalities of unknown
significance.
Decrease of ≥ 50% in

RECIST Definition
Not applicable

Not applicable

Disappearance of all
target lesions for a period
of at least one month.

Complete response with
persistent imaging
abnormalities of unknown
significance.

At least a 30% decrease

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total tumor load of the
lesions that have been
measured for at least 4
weeks.

No Response/Stable
Disease (NR/SD)

Progressive Disease
(PD)

Relapse (untreated)

in the sum of the longest
diameter of measured
lesions (target lesions),
taking as reference the
baseline sum of longest
diameter.

Partial response may be
represented as PR1,
PR2, etc. There are
differing interpretations of
what the number after
“PR” represents, and this
can be confusing.
What is important to
CIBMTR data analysis is
to distinguish the type of
PR as either: “without
prior CR” or “with prior
CR.”
Question 306: Specify
If the recipient is in a partial response, indicate
whether there was a previous CR.
Disease has been treated Neither sufficient
and the size of one or
shrinkage to qualify for
more lesions has neither PR nor sufficient increase
increased 25% or more in to qualify for PD, taking
the size of one or more
as reference the smallest
lesions, nor has total
sum of the longest
tumor size decreased
diameter since the
50% or more.
treatment started.
Increase of ≥ 20% in the
At least a 20% increase
size of one or more
in the sum of the longest
measurable lesions, or
diameter of measures
the appearance of new
lesions (target lesions),
lesions.
taking as reference the
smallest sum longest
diameter recorded since
the treatment started or
the appearance of one or
more new lesions.
The reappearance of
Not applicable.
disease after complete
recovery. Should be
determined by one or
more diagnostic tests.
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Question 307: Was Response Evaluation Criteria in Solid Tumors (RECIST)
used for this status evaluation?
Check “yes” or “no” to indicate whether the RECIST disease response definitions
were used to evaluate the recipient’s status. For more information regarding
RECIST criteria, see appendix N.
Question 308: CR, CRU or relapse, number
Indicate which number the response represents.
Question 309: REL, sensitivity to chemotherapy
Indicate if the disease is sensitive to chemotherapy. Sensitivity is measured
based on the last chemotherapy given prior to HSCT; chemotherapy must
include ≥ 2 cycles of treatment given ≤ 6 months prior to HSCT. Sensitivity is
defined as ≥ 50% reduction in bi-dimensional diameter of all disease sites with no
new sites of disease. Resistant is defined as < 50% reduction in diameter of all
disease sites or development of new disease sites. If the last treatment was not
chemotherapy, then report as “untreated” (by chemotherapy).
NOTE: Malignant vs. Non-malignant
Malignant diseases involve cells dividing without control, which can spread to
other parts of the body through the 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.
The diseases listed in the following section are non-malignant.

Anemia/Hemoglobinopathy
Questions 310-313: Classification
Indicate the disease classification at diagnosis.

Platelet Disorders
Questions 314-315: Classification
Indicate the disease classification at diagnosis.

Histiocytic Disorders
Questions 316-317: Classification
Indicate the disease classification at diagnosis.
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Inherited Disorders of Metabolism/Osteopetrosis
Questions 318-319: Classification
Indicate the disease classification at diagnosis.

Immune Deficiencies
Questions 320-322: Classification
Indicate the disease classification at diagnosis.

Autoimmune Disorders
NOTE:
For all recipients with autoimmune disease, the Pre-TED form should be
submitted at the time of mobilization.
Question 323: Autoimmune Deficiencies, Specify
Indicate the disease classification at diagnosis.

Systemic Sclerosis (Connective Tissue Disease)
NOTE: Questions 324-347
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply
TM

Questions 324-347: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.
Questions 348-350: Miscellaneous Labs at Original Diagnosis
For each antibody listed, indicate whether the result was normal, elevated, or not
done.

Systemic Lupus Erythematosus (Connective Tissue Disease)
NOTE: Questions 351-377
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
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Questions 351-377: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.
Questions 378-384: Miscellaneous Labs at Original Diagnosis
For each test listed, indicate whether the result was normal, abnormal, or not
done.

Sjögren Syndrome (Connective Tissue Disease)
NOTE: Questions 385-397
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 385-397: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.

Polymyositis-dermatomyositis (Connective Tissue Disease)
NOTE: Questions 398-412
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 398-412: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.
Questions 413-416: Miscellaneous Labs at Diagnosis
For each test listed, indicate whether the result was normal, elevated, or not
done.

Antiphospholipid Syndrome (Connective Tissue Disease)
NOTE: Questions 417-432
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
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Questions 417-432: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.
Questions 433-436: Miscellaneous Labs at Diagnosis
For each test listed, indicate whether the result was normal, elevated, or not
done.

Other Connective Tissue Disease
Question 437: Other connective tissue disease, specify:
Specify the other connective tissue disease classification at the time of original
diagnosis.

Wegener Granulomatosis (Vasculitis)
NOTE: Questions 438-449
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 438-448: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.
Questions 450-454: Miscellaneous Labs at Diagnosis
For each antibody listed, indicate whether the result was normal, elevated, or not
done.

Polyarteritis Nodosa, Classical and Microscopic (Vasculitis)
NOTE: Questions 455-468
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 455-468: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.
Questions 469-471: Miscellaneous Labs at Diagnosis
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For each test listed, indicate whether the result was normal, elevated, or not
done.

Churg-Strauss, Giant Cell Arteritis, Takayasu, Behçet’s
Syndrome, and Overlap Necrotizing Arteritis
If the recipient’s primary disease is listed in the box above, check the appropriate
disease, and submit the form.

Other Vasculitis
Question 472: Other vasculitis, specify
Specify the other vasculitis disease classification at the time of original diagnosis.

Rheumatoid Arthritis
NOTE: Questions 473-487
FormsNet 2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 473-487: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.

Psoriatic Arthritis/Psoriasis
NOTE: Questions 488-494
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 488-494: Involved Organs/Clinical Problem(s) and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problem(s) at the time of original
diagnosis, and whether or not that involvement was the primary reason for the
HSCT.

Juvenile Idiopathic Arthritis: Other
Question 495: Juvenile idiopathic arthritis: other, specify
Specify the other juvenile idiopathic arthritis disease classification at the time of
original diagnosis.
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Other Arthritis
Question 496: Other arthritis, specify
Specify the other arthritis disease classification at the time of original diagnosis.

Multiple Sclerosis
NOTE: Questions 497-505
FormsNetTM2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 497-505: Involved Organs/Clinical Problem and Primary
Reason(s) for Transplant
Indicate the involved organs and/or clinical problems at the time of original
diagnosis, and whether that involvement was the primary reason for the HSCT.

Myasthenia Gravis
If the recipient’s primary disease is Myasthenia gravis, check the box and submit
the form.

Other Autoimmune Neurological Disorder
Question 506: Other autoimmune neurological disorder, specify
Specify the other autoimmune neurological disorder at the time of original
diagnosis.

Idiopathic Thrombocytopenic Purpura (ITP), Hemolytic Anemia,
and Evan Syndrome
If the recipient’s primary disease is listed in the box above, check the appropriate
disease, and submit the form.

Other Autoimmune Cytopenia
Question 507: Other autoimmune cytopenia, specify
Specify the other autoimmune cytopenia disease classification at the time of
original diagnosis.

Crohn’s Disease and Ulcerative Colitis
If the recipient’s primary disease is listed in the box above, check the appropriate
disease, and submit the form.
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Other Autoimmune Bowel Disorder
Question 508: Other autoimmune bowel disorder, specify
Indicate the disease at the time of original diagnosis.

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