Stem Cell Therapeutic Outcomes Database (Pre-TED Form 2400)

Instructions for Pre-Transplant Essential Data (Pre-TED) Form
(Version 2)
This section of the CIBMTR Forms Instruction Manual is intended to be a resource for
completing the Pre-Transplant Essential Data (Pre-TED) Form (Version 2).
Effective December 3, 2007, the Pre- and Post-TED forms replaced the former PreRegistration (Pre-Reg), Transplant Essential Data (TED), Modified TED (M-TED) and
TED Follow-up (TEDFU) registration forms.
E-mail comments regarding the content of the CIBMTR Forms Instruction Manual to:
[email protected]. Comments will be considered for future
manual updates and revisions. For questions that require an immediate response,
please contact your transplant center’s CIBMTR liaison.

TABLE OF CONTENTS
Abbreviations ......................................................................................................... 4
Key Fields .............................................................................................................. 6
CIBMTR Use Only ................................................................................................. 6
Disease Classification............................................................................................ 6
Table 1. Common Diagnosis Combinations ........................................................ 7
Table 2. Common Diagnosis Transformations ..................................................... 7
Hematopoietic Stem Cell Transplant (HSCT) ........................................................ 8
Preparative Regimen ........................................................................................... 18
Example: Calculating Drug Doses ...................................................................... 20
Comorbid Conditions ........................................................................................... 23
GVHD Prophylaxis (allogeneic only) .................................................................... 26
Post-HSCT Disease Therapy Planned as of Day 0 ............................................. 26
Other Toxicity Modifying Regimen ....................................................................... 27
Pre-TED Disease Classification Sheet ................................................................ 28
Leukemias ........................................................................................................... 29
Acute Myelogenous Leukemia (AML) or
Acute Nonlymphocytic Leukemia (ANLL) ........................................................... 29
Acute Lymphoblastic Leukemia (ALL) ................................................................ 33
Other Acute Leukemia........................................................................................ 37
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TABLE OF CONTENTS (cont.)
Chronic Myelogenous Leukemia (CML) ............................................................. 41
Table 3. CML Classifcation Requirements ......................................................... 41
Myelodysplastic (MDS) or Myeloproliferative Diseases (MPS)........................... 46
MDS/MPS/Chronic Myelomonocytic Leukemia (CMML) .................................... 48
Juvenile Myelomonocytic Leukemia (JMML) ...................................................... 51
Other Leukemias ................................................................................................ 52
Lymphomas ......................................................................................................... 58
Hodgkin’s Lymphoma (HL) ................................................................................. 59
Non-Hodgkin’s Lymphoma (NHL) ...................................................................... 61
Plasma Cell Disorders ......................................................................................... 64
Table 4. Plasma Cell Disorders: Disease Combinations .................................... 64
Table 5. Durie-Salmon Staging (DSS)................................................................ 65
Table 6. Disease Status Definitions ................................................................... 67
Breast Cancer...................................................................................................... 71
“Other” Disease ................................................................................................... 75
Other Malignancies .............................................................................................. 76
Anemia/Hemoglobinopathy.................................................................................. 79
Platelet Disorders ................................................................................................ 79
Histiocytic Disorders ............................................................................................ 79
Inherited Disorders of Metabolism/Osteopetrosis ................................................ 80
Immune Deficiencies ........................................................................................... 80
Autoimmune Disorders ........................................................................................ 80
Systemic Sclerosis ............................................................................................. 80
Systemic Lupus Erythematosus ......................................................................... 80
Sjögren Syndrome.............................................................................................. 81
Polymyositisdermatomyositis ............................................................................. 81
Antiphospholipid Syndrome................................................................................ 81
Other Connective Tissue Disease ...................................................................... 81
Wegener Granulomatosis .................................................................................. 81
Polyarteritis Nodosa, Classical and Microscopic ................................................ 82
Churg-Strauss, Giant Cell Arteritis, Takayasu, Behçet’s Syndrome,
and Overlap Necrotizing Arteritis ........................................................................ 82
Other Vasculitis .................................................................................................. 82
Rheumatoid Arthritis ........................................................................................... 82
Psoriatic Arthritis/Psoriasis ................................................................................. 82

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TABLE OF CONTENTS (cont.)
Juvenile Idiopathic Arthritis: Systemic (Stills disease), Oligoarticular,
Polyarticular ......................................................................................................... 83
Juvenile Idiopathic Arthritis: Other ...................................................................... 83
Other Arthritis ..................................................................................................... 83
Multiple Sclerosis ............................................................................................... 83
Myasthenia Gravis.............................................................................................. 83
Other Autoimmune Neurological Disorder .......................................................... 83
Idiopathic Thrombocytopenic Purpura (ITP), Hemolytic Anemia,
and Evan Syndrome ........................................................................................... 83
Other Autoimmune Cytopenia ............................................................................ 84
Crohn’s Disease and Ulcerative Colitis .............................................................. 84
Other Autoimmune Bowel Disorder .................................................................... 84

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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.
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.,
palifermin, Kepivance)
NMDP = National Marrow Donor
Program
NOS = Not Otherwise Specified
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

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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 (see Helpful Hint below). 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 avoid having to make changes to HSCT date, complete the data for the PreTED (in FormsNet2™ 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
Recipient Baseline Form (Form 2000).
For all subsequent HSCTs, the recipient will remain on the original follow-up form
track assigned by the form selection algorithm. For more information regarding
center type and the form selection algorithm, see General Instructions, Center
Type and Data Collection Forms.
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 FormsNet2™
until the Post-TED from the previous transplant has been completed.
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Transplant centers can use the FormsNet2™ application to determine if a Recipient
Baseline Form (Form 2000) is due by either: 1) accessing the Forms Due Report, or 2)
entering the recipient’s unique ID (CRID) in the Patient Forms Due field.

Key Fields
Accuracy of the Key Fields is essential for ensuring that:
Data are being reported for the correct recipient.
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 FormsNet2™ 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 corresponding Disease Classification Sheet in the disease
specific section at the end of the form 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 with 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

Report primary
disease as:

Report disease
diagnosis date of:

Required disease
classification sheet(s)

MDS or MPS to AML

AML

AML

AML and MDS/MPS

NHL to another NHL

Second NHL
diagnosis

First NHL diagnosis

Lymphoma

CLL to NHL
Other Leukemias and
NHL
CLL
(i.e., Richter’s Syndrome)
Lymphoma
AML, acute myelogenous leukemia; AMY, amyloidosis; CLL, chronic lymphocytic leukemia; FAN, Fanconi
anemia; MDS, myelodysplastic syndrome; MPS, myeloproliferative syndrome/disease; MYE,
myelodysplasia; NHL, Non-Hodgkin’s lymphoma; SAA, severe aplastic anemia.

NOTE:
Question numbers correspond to the FormsNet2TM application
Question 1: Indicate the broad disease for which the HSCT is performed (see
question 177)
From the list provided, select the primary disease for which the recipient is receiving the
HSCT.
Question 2: Date of diagnosis of primary disease for HSCT
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.
Report the date of the first pathological diagnosis (e.g., bone marrow or tissue biopsy)
of the disease. Enter the date the sample was collected for examination. If the diagnosis
was determined at an outside center, and no documentation of a pathological or
laboratory assessment is available, the dictated date of diagnosis within a physician
note may be reported. Do not report the date symptoms first appeared.
If the exact pathological diagnosis date is not known, use the process described in
General Instructions, Guidelines for Completing Forms.
If this is a subsequent 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
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algorithm, the diagnosis date and current status of the previous diagnosis will be
reported on the Post-TED.

Hematopoietic Stem Cell Transplant (HSCT)
Question 3: Date of this HSCT
Report the intended start date of the HSCT. If the infusion is planned to last several
days, enter the first 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
FormsNet2™ 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 4: Chronological number of this HSCT
An HSCT 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, as opposed to three HSCTs and should be counted as
HSCT #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 #2.
Example 2:
A recipient previously received a HSCT (HSCT #1). Then, because of delayed
neutrophil recovery, the recipient received additional mobilized cells (i.e.,
“boost”). Report the boost as HSCT #2.
After receiving the boost, the recipient has relapse of disease. The recipient is
scheduled to receive a subsequent HSCT. The subsequent HSCT should be
reported as HSCT #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 disease.
Report the chronological number of this HSCT. If “>1,” continue with question 5. If this is
the recipient’s first HSCT, continue with question 11.
See Appendix O for additional information regarding distinguishing infusion types.
Question 5: If >1, most recent previous HSCT
Reporting the recipient’s last HSCT enables the CIBMTR to appropriately account for
recipient survival status in the database.
Report the date of the recipient’s last autologous or allogeneic (related or unrelated)
HSCT prior to the one being reported. Although the CIBMTR requests either a Pre-TED
and/or Recipient Baseline Form (Form 2000) for each HSCT, there may be
circumstances where a prior HSCT was not reported (e.g., prior autologous HSCT).
Question 6: Type
Report the stem cell source of the recipient’s last HSCT as either autologous or
allogeneic.
Questions 7-10: Institution where previous HSCT was performed if different from
current
These data are used to identify and link the recipient’s existence in the database and, if
necessary, to obtain data from the previous transplant center.
Report the name, city, state, and country of the institution where the recipient’s last
HSCT was performed.

NOTE: Questions 11-16
FormsNet2TM application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 11-16: 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 in question 16.
For more information regarding multiple cell type infusions that occur over a short period
of time (e.g., several infusions with different cell sources occurring in less than two
weeks), contact your center’s CIBMTR liaison.
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Question 17: Autologous HSCT?
Indicate if this HSCT is autologous (self-donation). If “yes,” continue with question 18. If
“no,” continue with question 19.
Question 18: Specify number of products
A series of collections should be considered a single product when they are all from the
same donor and use the same collection method and technique (and mobilization, if
applicable), even if the collections are performed on different days.
Report the number of products used for this autologous HSCT.
Question 19: Multiple donors?
Indicate if multiple donor types, or if multiple cord blood units from different donors are
to be used for this HSCT. If “yes,” continue with question 20. If “no,” continue with
question 21.
Question 20: Specify number of donors
Report the number of donors used for this HSCT.
NOTE: Questions 21-28, reporting more than one donor
FormsNet2™ application: Complete questions 21-28 for each donor.
Paper form submission: Copy questions 21-28 and complete for each donor. Check
the box on the paper form to indicate additional pages are attached.
Questions 21-22: Allogeneic HSCT donor gender
Indicate the allogeneic donor’s biological gender (sex) as “male” or “female.”
Question 23: 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).
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HLA-matched other relative:
Includes: All blood-related relatives, other than siblings, who are HLA
matched (e.g., parents, aunts, uncles, children, cousins, half-siblings).
Does not include: Adoptive parents/children or stepparents/children who
are HLA matched.
If the donor is a syngeneic, HLA-identical sibling, or HLA-matched other relative,
continue with question 29.
HLA-mismatched relative:
Includes: Siblings who are not HLA-identical and all other blood-related
relatives who have at least one HLA mismatch (e.g., parents, aunts,
uncles, children, cousins, half-siblings).
Does not include: Adoptive parents/children or stepparents/children.
If the donor is an HLA-mismatched relative, continue with question 24.
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.
If the donor is an unrelated donor, continue with question 25.
Question 24: 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 25: 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 use the registry code of the registry that facilitated
the HSCT.
If the registry code cannot be determined using the BMDW website, continue to
question 26.
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NOTE: Question 25
FormsNet2™ 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
Example: Registry name: Against Leukemia Foundation Marrow Donor Registry
Match codes: Poland-ALF MDR [PL3]
Report on Pre-TED: PL3
Question 26: 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 rarely be used.
NOTE: Reporting HLA mismatches on the Pre-TED forms
The Pre-TED currently requires that HLA mismatches are reported for unrelated
products at the HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 loci. Validation within the
FormsNet3™ data entry system requires that data fields for each locus at the antigenic
(2 digits) and allelic (4 digits) be completed. Please review the updated instructions
below for guidance in reporting HLA mismatches.
In order to interpret HLA typing results, start at a locus such as HLA-A*. Find the “*” and
look at the numbers going to the right. The first two digits are the antigen family. If the
digits 1 and 2 match, then move to digits 3 and 4 (and sometimes digit 5). The 3rd, 4th,
and occasional 5th digits are at the allelic level.
If the numbers between the donor and the recipient don’t match within digits 1 and/or 2,
the number of mismatches should be reported in the antigen section. If the numbers
between the donor the recipient match within the digits 1 and 2, but not digits 3 and/or 4
(or 5, if applicable), the number of mismatches should be reported in the allele section.
However, The HLA typing may contain an “allele string” (e.g., HLA-A*02:01/02/03/04) or
an “allele code” (e.g., HLA-A*02:RV), making it impossible to match the product and the
donor at the allelic level (4 digits). If there is an allele code after digits 1 and 2, then the
match/mismatch should be reported at the antigenic level.
Report mismatches at each loci using the level (antigenic or allelic) where matching is
possible. For example, high-resolution DNA typing is available for the recipient, but only
intermediate-resolution DNA typing is available for the product and the HLA typing
contains an allele code at the A and B loci. In this case, the antigenic level (2 digits)
should be completed for the number of mismatches at A and B and the allelic level
should be reported as “ND = not done” for those loci.
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If matching is possible at the allelic level, the antigenic level should be reported as “ND
= not done.” Only one result per locus should be reported (antigenic or allelic), and the
remaining field should be reported as “ND = not done.” Please see the examples below,
where each example approximates a different style of HLA report (these examples are
not comprehensive and style varies significantly between laboratories):
Example 1.
HLA Results
Relation
Patient
Unrelated
Donor

Hap
a
c

A*
01:01
01:01

B*
52:01
52:01

C*
12:02
12:02

DRB1*
15:02
15:02

DRB3*
NEG

DRB4*
NEG

DRB5*
POS

DQB1*
06:BVAH
06:BVAH

01:BUYK

52:FWM

12:02

15:02

NEG

NEG

POS

06:BVAH

Reporting on the Pre-TED form:
HLA Antigenic (2 digits):
HLA-A locus:
0 = matched1, 6
HLA-B locus:
0 = matched1, 6
HLA-C locus:
ND = not done2, 6
HLA-DRB1 locus: ND = not done2, 6
HLA-DQB1 locus: 0 = matched1, 6
HLA-DPB1 locus: ND = not done3, 6

HLA Allelic (4 digits):
HLA-A locus:
ND = not done
HLA-B locus:
ND = not done
HLA-C locus:
0 = matched
HLA-DRB1 locus: 0 = matched
HLA-DQB1 locus: ND = not done
HLA-DPB1 locus: ND = not done

Example 2.
HLA Results (red added for emphasis)
Relation
Patient
Donor

A
*30:01
*30:02

B
*07:02
*35:01

Cw
*04:01
*15:05

DRB1
*11:02
*03:19

4

DQB1
*03:19
*06:09

*30:01
*74:01

*07:06
*35:01

*04:01
*15:05

*15:03
*11:02

*03:19
*06:02

Reporting on the Pre-TED form:
HLA Antigenic (2 digits):
HLA-A locus:
1 = mismatch
HLA-B locus:
ND = not done2
HLA-C locus:
ND = not done2
HLA-DRB1 locus: 1 = mismatch
HLA-DQB1 locus: ND = not done2
HLA-DPB1 locus: ND = not done3

HLA Allelic (4 digits):
HLA-A locus:
ND = not done5
HLA-B locus:
1 = mismatch
HLA-C locus:
0 = matched
HLA-DRB1 locus: ND = not done5
HLA-DQB1 locus: 1 = mismatch
HLA-DPB1 locus: ND = not done

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Example 3.
HLA Results
HLAA*
B*
Cw*
DRB1*
DQB1*

Patient
01:01/01N, 26:01
08:01, 58:01
03:02, 07:01/06/18
03:01, 03:01/68
02:01, 02:01

Donor
01:01/01N, 26:01
08:01, 58:01
03:02, 07:01/06/18
03:01, 03:01/68
02:01, 02:01

Reporting on the Pre-TED form:
HLA Antigenic (2 digits):
HLA-A locus:
0 = matched1
HLA-B locus:
ND = not done2
HLA-C locus:
0 = matched1
HLA-DRB1 locus: 0 = matched1
HLA-DQB1 locus: ND = not done2
HLA-DPB1 locus: ND = not done3

HLA Allelic (4 digits):
HLA-A locus:
ND = not done
HLA-B locus:
0 = matched
HLA-C locus:
ND = not done
HLA-DRB1 locus: ND = not done
HLA-DQB1 locus: 0 = matched
HLA-DPB1 locus: ND = not done

Example 4.
HLA Results
Patient
Donor

A
*24:xx
*24:xx

A
*29:xx

B
*07:xx
*44:03

B
*44:03
*07:xx

C
*16:01
*07:xx

C
*07:02/*0703/*0710
*16:01

DRB1
*13:01
*13:01

DRB1
*15:01
*15:01

DQB1
*06:02
*06:02

Reporting on the Pre-TED form:
HLA Antigenic (2 digits):
HLA-A locus:
1 = mismatch6
HLA-B locus:
0 = matched1
HLA-C locus:
0 = matched1
HLA-DRB1 locus: ND = not done2
HLA-DQB1 locus: ND = not done2
HLA-DPB1 locus: ND = not done3

HLA Allelic (4 digits):
HLA-A locus:
ND = not done
HLA-B locus:
ND = not done
HLA-C locus:
ND = not done
HLA-DRB1 locus: 0 = matched
HLA-DQB1 locus: 0 = matched
HLA-DPB1 locus: ND = not done

1

The loci could not be matched at the allelic level due to the allele string or code in the reported HLA
typing. Allele strings or allele codes represent the “lowest resolution” at which matching is possible.
2

Counting antigenic mismatches is possible with the available HLA data, but counting allelic level
mismatches provides more specific information. In cases where counting allelic level mismatches is
possible, antigenic level mismatches should be reported as “ND = not done.”
3

DPB1* was not tested for the recipient and/or donor.

4

The“first” patient DRB1 result matches the “second” donor DRB1 result, while the remaining patient and
donor at DRB1 results do not match. This is a single mismatch at the antigenic level for the HLA-DRB1
locus.
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*06:03
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5

The mismatch is present at the antigenic level (2 digits), even though allelic level typing was performed.
Since a mismatch is reported at the antigenic level, the allelic level should be reported as “ND = not
done.”
6

A blank typing is considered a duplicate of the result that was reported.

Question 27: Complete number of mismatches: Antigenic (2 digits)
For unrelated donors, if HLA testing was serologic or low-resolution DNA typing, or
intermediate-resolution DNA Typing, indicate the number of mismatches for each locus
(Note: A full match equals “0” mismatches). For assistance with HLA typing and
terminology, consult a specialist within your institution, or contact your center’s CIBMTR
CRC.
Question 28: Complete number of mismatches: Allelic (4 digits)
For unrelated donors, if the HLA testing was allele level typing, indicate the number of
mismatches for each locus (Note: A full match equals “0” mismatches). For assistance
with HLA typing and terminology, consult a specialist within your institution, or contact
your center’s CIBMTR CRC.
Question 29: Was there Ex Vivo Graft Manipulation other than for red blood cell
(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.
Cryopreservation or product thaw should not be reported as product manipulation.
If the graft was manipulated ex vivo other than for RBC removal or volume
reduction, check “yes” and continue with questions 30-37.
If the graft was only manipulated to reduce the volume of the product (to reduce the use
of DMSO or cryopreservation) or to remove RBCs (for ABO incompatibility, to prevent
hemolysis), check “no” and continue with question 38.
NOTE: Questions 30-37
FormsNet2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Question 30: 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).

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Question 31: Tumor purging
This type of negative selection manipulation removes malignant cells from the collected
product. This method is only used for autologous HSCT.
Questions 32-33: 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 34: 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.
Question 35: 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 36-37: 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 38-39: Performance Score pre-Preparative Regimen
Recipient performance status is a critical data field that has been determined to be
essential for all outcome-based studies.
The CIBMTR uses the Karnofsky/Lansky scale to determine the functional status of the
recipient immediately prior to the start of the preparative regimen. For the purposes of
this manual, the term “immediately prior” represents the pre-HSCT work-up phase, or
approximately one month prior to the start of the preparative regimen. In cases where
the pre-transplant work-up occurs in months prior to transplant (i.e., the pre-transplant
workup occurs more than one month prior to transplant), a documented performance
score may be submitted if the recipient does not have a score closer to the start of the
preparative regimen, the recipient receives no additional treatment after the date of
assessment, and the recipient’s status does not clearly decline.
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
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recipient’s activity status immediately prior to the start of the preparative regimen. For
an example of the Karnofsky/Lansky scale, see Appendix L.
If a Karnofsky/Lansky score is not documented in the source documentation (e.g.,
inpatient progress note, physician’s clinic note), data management professionals
should not assign a performance score based on analysis of available documents.
Rather, a physician should provide documentation of the performance score.
The CIBMTR recognizes that some transplant centers prefer to collect and use the
ECOG performance score as opposed to the Karnofsky/Lansky score. Although the
ECOG and Karnofsky/Lansky performance score systems are based on similar
principles, the scales are not the same. For example, the Karnofsky/Lansky scale is
described in 11 categories, whereas the ECOG performance status is reported in six
categories. Due to the overlap between the two systems, an ECOG score of “one” can
represent either “80” or “90” on the Karnofsky/Lansky scale. For centers that collect only
an ECOG performance score, CIBMTR will make the following accommodations when
auditing the source data:
Centers collecting ECOG scores should do so using standard practices to
ensure accuracy.
For the purposes of CIBMTR reporting, conversion of ECOG to
Karnofsky/Lansky should follow a standard and consistent practice. This
practice should be clear and reproducible.
For more information regarding converting an EGOG score to a Karnofsky/Lansky
score, see Appendix L.
Questions 40-41: 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 pre-HSCT 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. In cases where the pre-transplant work-up occurs in
months prior to transplant (i.e., the pre-transplant workup occurs more than one month
prior to transplant), a CMV assessment may be submitted if the recipient does not have
an assessment closer to the start of the preparative regimen.
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
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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 inconclusive or 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 or if the laboratory
reports CMV testing by PCR (DNA detection). CMV testing by PCR is used to detect the
presence of the CMV virus and does not test for prior exposure.
If the allogeneic donor product was a cord blood unit, “non-reactive” should be reported
for the donor CMV status. If the cord blood unit test results are reactive, it’s due to
transplacental maternal antibodies and do not need to be reported as “reactive.”
If multiple donors are used for this HSCT, report any positive result as reactive.

Preparative Regimen
Question 42: 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
questions 43-122. If a preparative regimen is not planned, check “no” and continue with
question 123.
For more information regarding the recipient’s preparative regimen, consult with a
transplant physician or contact your center’s CIBMTR liaison.
NOTE: Questions 43-115
FormsNet2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

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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 Recipient Baseline Form (Form 2000).
Question 43: Total Body Irradiation (TBI)
If TBI is prescribed per protocol, check “yes” and continue with question 44. 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 45.
Question 44: 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 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 45: TLI, TNI, or TAI
If Total Lymphoid Irradiation (TLI), Total Nodal Irradiation (TNI), or Total Abdominal
Irradiation (TAI) is prescribed per protocol, check “yes” and continue with question 46. If
TLI, TNI, or TAI is not prescribed per protocol, check “no” and continue with question
47.
Question 46: 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).
NOTE: 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 Recipient
Baseline Form (Form 2000). Do not include drugs that are intended to offset the
side effects of the chemotherapy (e.g., corticosteroids for nausea, MESNA for
hemorrhagic cystitis, etc.).
ATG and Campath given for GVHD prophylaxis planned prior to Day 0 should be
reported in the preparative regimen section of the Pre-TED. If ATG and Campath are
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planned after Day 0, it should be reported in the GVHD prophylaxis section (questions
145-162).
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 47-115: 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 in 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 mg/kg (e.g.,
Campath, pediatric doses of busulfan), leave the unit field blank and attach a copy of
the source document to the Pre-TED using the Log of Appended Documents (Form
2800).
Example: Calculating Drug Doses
Drug doses are calculated either by recipient weight in kilograms (kg) or recipient body
surface area (BSA) in m2. The HSCT protocol will specify “x mg/kg” or “x mg/m2” and
the total number of doses to be administered.
For example, if the protocol requires Cyclophosphamide, 60 mg/kg x 2 days (i.e., 2
doses), the “total prescribed dose” should be reported as “120 mg/kg.”
Some drugs used as part of the preparative regimen are administered with guidance of
serum pharmacokinetic testing to determine the recipient’s metabolism of the drug. This
allows for “customization” of the drug dosing to the individual to optimize the desired
effect and minimize the toxicity.
Busulfan represents a common example of this situation. In some cases, the first dose
of the drug is given in the usual fashion as part of the preparative regimen. After the first
dose, blood is drawn and sent to a reference lab to determine serum drug levels. Once
the lab results are reported, the drug is continued with adjustment of later doses. In
other situations, a “test dose” of the drug is given before the actual preparative regimen
is started, and this dose is used for acquiring drug levels that are used to adjust the
dose that will be used in the preparative regimen.
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When a drug is used for the preparative regimen where pharmacokinetics will be tested,
it is important to distinguish whether the testing will be done using the first dose of the
preparative regimen or if the drug will be given as a “test dose” distinct from the
beginning of the preparative regimen. The reporting of the “total prescribed dose” for the
Pre-TED depends upon this distinction.
1. The first dose of therapeutic dosing is used for monitoring.
Example: Patient with MDS is scheduled to receive an allogeneic HSCT from
an unrelated donor using Busulfan and Fludarabine preparative regimen.
Busulfan is prescribed 0.8 mg/kg every 6 hours over 4 days, total of 16 doses.
The protocol states that serum samples will be drawn after the first dose
every 30 minutes until the second dose is administered to determine if
adjustment to the dosing is needed. The total prescribed dose per protocol
should be reported as “13 mg/kg.” 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 Recipient Baseline Form (Form
2000).
2. The test dose is given ≥ 24 hours prior to the intended therapeutic dosing.
Example: Patient with AML is scheduled to receive an allogeneic HSCT from
sibling using Busulfan and Cyclophosphamide preparative regimen. The
patient presents to clinic 9 days before the HSCT, where a dose of Busulfan
at 0.5 mg/kg is given intravenously. Blood samples are drawn for the next 6
hours, after which the patient leaves the clinic. The patient’s samples are sent
to a lab, results are returned the next day and an adjusted dose of Busulfan is
calculated to be used for the preparative regimen of 1.0 mg/kg every 6 hours
over 4 days, total of 16 doses. The total prescribed dose per protocol should
be reported as “16 mg/kg.” In this scenario, the “test dose” is not included in
the “prescribed total dose.”
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 Documents (Form 2800).Do not report additional sites of radiation
(e.g., cranial boost) in the “other” drug category. If the recipient is assigned to the
comprehensive Report Forms by the form selection algorithm, the additional sites of
radiation will be reported on the Recipient Baseline Form (Form 2000). If the recipient is
assigned to TED Forms by the form selection algorithm, the additional sites of radiation
will not be reported.
If the Pre-TED is being completed for a subsequent 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.
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If there is a change to the chemotherapy preparative regimen (e.g., from Busulfan +
Fludarabine to Melphalan + Fludarabine) after form 2400 has been submitted, an error
correction must be completed to update the chemotherapy regimen given.
Question 116: Is the intent of the preparative regimen myeloablative (allo only)?
The purpose of a myeloablative HSCT is to destroy malignant cells using high-dose
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 to suppress the recipient’s hematopoietic immune system without
eliminating 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 recipients who are older or who have other
health problems, as the lower chemotherapy and/or radiation doses are better tolerated.
Currently, there are no published definitions of the difference between NST and RIC
preparative regimens. However, in general, a RIC includes any regimen not meeting the
criteria for either myeloablative or NST regimens.
Examples of myeloablative preparative regimens:
busulfan (16 mg/kg) and cyclophosphamide (120 mg/kg)
cyclophosphamide (120 mg/kg) and TBI (12 Gy)
Examples of non-myeloablative preparative regimens:
2 Gy TBI
fludarabine (180 mg/m2) and cyclophosphamide (120 mg/kg)
TLI (8 Gy) and ATG (8 mg/kg)
Centers must attribute the intent of the regimen based on the standards at their
center. Generally speaking, the attribution should be based on the protocol or on the
opinion of the physician overseeing the care of the recipient at your center.
If the intent of the preparative regimen is myeloablative (resulting in marrow ablation or
pancytopenia by destroying blood-producing cells in the bone marrow), check “yes” and
continue with question 123.
If the preparative regimen is intended to be NST or RIC, check “no” and continue with
question 117.

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NOTE: Questions 117-122
FormsNet2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 117-122: Reason for NST/RIC
Indicate the reason or reasons a non-myeloablative or reduced-intensity preparative
regimen was prescribed.

Co-Morbid Conditions
NOTE: Questions 123-144
The following co-morbid condition questions are optional for non-U.S. centers.
Question 123: Is there a history of mechanical ventilation?
A history of mechanical ventilation may impact the recipient’s pulmonary function postHSCT. 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.
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.”

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Question 124: 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, check “yes.” If the recipient has not had a history of a proven invasive fungal
infection, check “no.” 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: 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.
NOTE: Questions 125-144
Prior to answering question 125, review the list of co-existing disease(s) and/or organ
impairments listed under questions 126-144.
Question 125: Were there clinically significant co-existing disease or organ
impairment at the time of patient assessment prior to preparative regimen?
Report “yes” to question 125 if the recipient has a documented history and/or current
diagnosis of any of the following:
Documented Medical History
Arrhythmia
a
Cardiac
Cerebrovascular disease
b
Heart valve disease
Inflammatory bowel disease
Peptic ulcer
Rheumatologic
c
Solid tumor, prior
Current diagnosis at the time of pre-HSCT evaluation
Diabetes
Hepatic, mild
Hepatic, moderate/severe
Infection
Obesity
Psychiatric disturbance
Pulmonary, moderate

Question Number
126
127
128
130
134
136
141
142
Question Number
129
131
132
133
135
137
138

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Pulmonary, severe
139
d
Renal, moderate/severe
140
Other (specify)
143 (144)
a
Ejection fraction (EF) ≤ 50% should be reported only if present at the time of the
pre-HSCT evaluation
b
Excluding mitral valve prolapse
c
Excluding nonmelanoma skin cancer
d
Including Renal transplantation at any time in the patient’s history

The intent of this question is to identify serious pre-existing conditions that may have an
effect 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 that 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 HSCT is allogeneic, and the recipient does not have a
documented history of clinically significant disease(s) or organ impairment(s), check
“no” and continue with question 145.
If the HSCT is autologous, and the recipient does not have a documented history of
clinically significant disease(s) or organ impairments, check “no” and continue with
question 163.
For information regarding reporting clinically significant co-existing disease or organ
impairment, see Appendix U.
Questions 126-144: Co-existing diseases or organ impairments
For each listed co-existing disease or organ impairment, check “yes,” “no,” or “not
done.”
Pulmonary (moderate or severe) coexisting disease/impairments should be measured
using the corrected DLCO (e.g., DLCOc, DLCOcorr, DLCO(Hb)) values.
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.
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The physician performing the recipient’s pre-HSCT evaluation may use the HCT CoMorbidity Index (HCT-CI) to document co-morbid conditions (see Appendix M).

GVHD Prophylaxis (allogeneic only)
Questions 145: 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.
If GVHD prophylaxis is planned per protocol, check “yes” and continue with question
146. If GVHD prophylaxis is not planned per protocol, check “no” and continue with
question 163.
NOTE: Questions 146-162
FormsNet2TM application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 146-162: GVHD prophylaxis drugs
The prophylactic drug options listed on the form are intended to be administered in a
systemic or oral form. If the recipient received one of the listed drugs in a topical form,
report the drug in the “other, specify” category.
Do not report T-cell depletion of the 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.

Post-HSCT Disease Therapy Planned as of Day 0
Question 163: 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
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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. If this HSCT is not
part of a planned multiple graft/HSCT protocol, check “no.”
Questions 164: 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. If additional post-HSCT therapy is not planned per
protocol, check “no” and continue with question 175.
NOTE: Questions 165-174
FormsNet2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

Questions 165-174: Additional post-HSCT planned therapy (optional for non-US
centers)
Indicate if the options listed on the form are intended to be part of the post-HSCT
planned therapy according to the protocol or standard of care. Report other planned
therapies in the “other, specify” category.

Other Toxicity Modifying Regimen
Questions 175-176 are optional for non-US centers.
Question 175: 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 176: 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 an FGF 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 given to
the recipient is known.
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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. A majority of the disease response criteria are established by an international
working group. Citations of resources used to define disease responses are included
where applicable.
If the recipient’s status is unclear, consult with the transplant physician for further
information or contact your center’s CIBMTR liaison.
NOTE: Malignant vs. Non-malignant
Malignant diseases involve cells dividing without control that can spread to other parts
of the body through blood and lymph systems. These diseases are usually
characterized by unlimited, aggressive growth, invasion of surrounding tissues, and
metastasis.
Non-malignant diseases involve cell overgrowth, but lack the malignant properties of
cancer.

Question 177: 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 (295)], and determining if the disease is malignant or nonmalignant. Disease codes (10-299) indicate a malignant disease, with the exception of
Paroxysmal Nocturnal Hemoglobinuria (PNH) (56). A disease code of (300) or above
indicates a non-malignant disease, with the exception of disease code (900), which could
indicate either a malignant or non-malignant disease.

Leukemias
Acute Myelogenous Leukemia (AML) or Acute Nonlymphocytic
Leukemia (ANLL)
Question 178: 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 179: 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.
AML can also evolve from Juvenile Myelomonocytic Leukemia (JMML). JMML is a rare
form of chronic leukemia that affects young children, usually before the age of five.
JMML results from DNA mutations in cells called monocytes. Normal monocytes attack
invading microorganisms and assist lymphocytes in carrying out immune functions.
Abnormal monocytes, or JMML cells, accumulate in the bone marrow and interfere with
the production of normal white blood cells, red blood cells, and platelets.
If AML transformed from MDS or MPS (including JMML), check “yes” and complete
both the AML and MDS/MPS Disease Classification Sheets (questions 222-234). If
AML did not transform from MDS or MPS, check “no.”
If MDS is suspected, but not confirmed by documented laboratory or pathologic
findings, or if there is documentation of MDS concurrent with AML, check “no.”
Question 180: Was AML therapy related?
Agents such as radiation or systemic therapy used to treat other diseases (e.g.,
Hodgkin’s lymphoma, Non-Hodgkin’s lymphoma, or breast cancer) 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 181. If the diagnosis of AML is
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not therapy related, check “no” and continue with question 184. If it is not known
whether the AML diagnosis is therapy related, check “unknown” and continue with
question 230.
Do not answer this question “yes” if the recipient developed AML after an environmental
exposure (e.g., exposure to benzene).
NOTE: Questions 181-183
FormsNet2TM application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
Questions 181-183: AML, therapy related
Indicate the therapy associated with the diagnosis of AML.
Question 184: Was imatinib mesylate given for pre-transplant therapy any time
prior to start of preparative regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B. Indicate
“yes,” “no,” or “unknown.”
Question 185: Status at Transplantation
Indicate the disease status of AML immediately prior to the start of the preparative
regimen.
Disease Status

Definition

Never Treated

The recipient was diagnosed with acute myelogenous
leukemia and never treated.
For example, 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.

Primary Induction
Failure (PIF)

The recipient was treated for acute leukemia, but never
achieved complete remission (CR) with any therapy.

Complete
Remission (CR)*

A treatment response where all of the following criteria are met for
at least four weeks:**

If yes, also
complete questions
186-188

< 5% blasts in the bone marrow
Normal maturation of all cellular components in the bone
marrow (myeloid, erythroid, and megakaryocytic lineages)
No blasts with Auer rods (AML only)
No extramedullary disease (e.g., central nervous system or

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soft tissue involvement)
ANC of > 1,000/µL
Platelets ≥ 100,000/µL
Transfusion independent
**Exception: 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 as it 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 recipient as being in CR at the time of transplant no matter
how many courses of therapy it may have taken to achieve that
CR.
Recipients who meet all the criteria of CR, but who have persistent
cytogenetic and/or molecular abnormalities, should be reported as
being in CR. The cytogenetic and/or molecular abnormalities
should be reported in the appropriate section (see questions 186187).
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).

Relapse

Recurrence of disease after CR. Relapse is defined as:

If yes, also
complete question
189.

> 5% blasts in the marrow
Extramedullary disease
Reappearance of cytogenetic abnormalities and/or
molecular markers associated with the diagnosis at
levels that, as determined by a physician, represent
relapse.

*Sources of disease response definitions:
1) www.uptodate.com
2) http://www.cancer.gov/
3) www.jco.ascopubs.org Cheson 21(24):4642-4649.

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FOR HEMATOLOGIC CR
Hematologic CR includes all the criteria listed for CR above. Indicate in questions 186187 if the response also qualified as a cytogenetic or molecular remission.
Question 186: Cytogenetic remission
Cytogenetic assessment involves testing blood or bone marrow for the presence of a
known cytogenetic abnormalities that reflect the recipient’s disease. FISH is categorized
with cytogenetics. Although often used for finding specific features in DNA, FISH is not
as sensitive as molecular methods, even though the markers identified may be the
same.
Cytogenetic remission is a treatment response where both of the following criteria are
met:
The karyotype reverts to normal, and
There are no clonal chromosomal abnormalities detected in the blood and/or
marrow.
If cytogenetic abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If cytogenetic abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No cytogenetic assessments were performed.
Cytogenetic abnormalities associated with the recipient’s disease were identified
previously and no cytogenetic assessment was performed prior to the start of the
preparative regimen.
Cytogenetic abnormalities associated with the recipient’s disease were not
identified on previous testing and no cytogenetic abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 187: 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 testing 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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If molecular abnormalities associated with the recipient’s disease were identified
previously, but the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If molecular abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No molecular assessments were performed.
Molecular abnormalities associated with the recipient’s disease were identified
previously and no molecular assessment was performed prior to the start of the
preparative regimen.
Molecular abnormalities associated with the recipient’s disease were not
identified on previous testing and no molecular abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 188: Number
Indicate the number of this hematologic CR.
FOR RELAPSE
Question 189: 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.

Acute Lymphoblastic Leukemia (ALL)
Question 190: Specify (disease classification)
Indicate the disease classification at diagnosis; the older FAB classifications are shown
in brackets, e.g., {L2}.
Due to the aggressive nature of Precursor T- and Precursor B-cell lymphoblastic
lymphoma (or lymphoma/leukemia), the primary disease reported for recipients with
these malignancies should be acute lymphoblastic leukemia (Precursor T-cell ALL or
Precursor B-cell ALL).
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The current WHO disease classification for ALL is divided between precursor B-cell 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 191: Was imatinib mesylate given for pre-transplant therapy any time
prior to start of prep regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B. Indicate
“yes,” “no,” or “unknown.”
Questions 192-196: Status at Transplantation
Indicate the disease status of ALL immediately prior to the start of the preparative
regimen.
Disease Status

Definition

Never Treated

The recipient was diagnosed with acute lymphoblastic leukemia
and never treated.

Primary Induction
Failure (PIF)

The recipient was treated for acute lymphoblastic 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.

Complete
Remission (CR)*

A treatment response where all of the following criteria are met for
at least four weeks:**

If yes, also
complete questions
193-195

< 5% blasts in the bone marrow
Normal maturation of all cellular components in the bone
marrow (myeloid, erythroid, and megakaryocytic lineages)
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

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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 and/or molecular
abnormalities who otherwise meet all the criteria of CR. The
cytogenetic and/or molecular abnormalities should be reported in
the appropriate section (see questions 193-194).
Do not include recipients with extramedullary disease. They
should be considered to have persistent disease, or to be in
relapse.
Recurrence of disease after CR. Relapse is defined as:

Relapse
If yes, also
complete question
196

> 5% blasts in the marrow
Extramedullary disease
Reappearance of cytogenetic abnormalities and/or
molecular markers associated with diagnosis at levels that,
as determined by a physician, represent relapse.

*Sources of disease response definitions:
1) www.uptodate.com
2) http://www.cancer.gov/
3) www.jco.ascopubs.org Cheson 21(24):4642-4649.

FOR HEMATOLOGIC CR
Questions 193-195: For hematologic CR
Hematologic CR includes all the criteria listed for CR above. For recipients who achieve
a hematologic CR, indicate in questions 193-195 if the response also qualified as a
cytogenetic or molecular remission.
Question 193: Cytogenetic remission
Cytogenetic assessment involves testing blood or bone marrow for the presence of
known cytogenetic abnormalities that reflect the recipient’s disease. FISH is categorized
with cytogenetics. Although often used for finding specific features in DNA, FISH is not
as sensitive as molecular methods, even though the markers identified may be the
same.
Cytogenetic remission is a treatment response where both of the following criteria are
met:
The karyotype reverts to normal, and
There are no clonal chromosomal abnormalities detected in the blood and/or
marrow.
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If cytogenetic abnormalities associated with the recipient’s disease were identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If cytogenetic abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No cytogenetic assessments were performed.
Cytogenetic abnormalities associated with the recipient’s disease were identified
previously, but no cytogenetic assessment was performed prior to the start of the
preparative regimen.
Cytogenetic abnormalities associated with the recipient’s disease were not
identified on previous testing and no cytogenetic abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 194: 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 testing 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).
If molecular abnormalities associated with the recipient’s disease were identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If molecular abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No molecular assessments were performed.
Molecular abnormalities associated with the recipient’s disease were identified
previously and no molecular assessment was performed prior to the start of the
preparative regimen.
Molecular abnormalities associated with the recipient’s disease were not
identified on previous testing and no molecular abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.

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Question 195: Number
Indicate the number of this hematologic CR.
FOR RELAPSE
Question 196: 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.

Other Acute Leukemia
Questions 197-198: 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 199: Was imatinib mesylate given for pre-transplant therapy any time
prior to start of prep regimen?
Imatinib mesylate is also known as Gleevec, Glivec, STI-571, or CGP57148B. Indicate
“yes,” “no,” or “unknown.”
Questions 200-204: Status at Transplantation
Indicate the disease status immediately prior to the start of the preparative regimen.
Disease Status

Definition*

Never Treated

The recipient was diagnosed with acute leukemia and never
treated.

Primary Induction
Failure (PIF)

The recipient was treated for acute leukemia, but never
achieved CR with any therapy. PIF is not limited to the

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number of treatments used unsuccessfully. This status only
applies to recipients who have never been in CR.
Complete
Remission (CR)

A treatment response where all of the following criteria are
met for at least four weeks:**

If yes, also
complete questions
201-203

< 5% blasts in the bone marrow
Normal maturation of all cellular components in the
bone marrow (myeloid, erythroid, and megakaryocytic
lineages)
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 and/or
molecular abnormalities who otherwise meet all the criteria of
CR. The cytogenetic and/or molecular abnormalities should
be reported in the appropriate section (see questions 201202).
Do not include recipients with extramedullary disease. They
should be considered to have persistent disease, or to be in
relapse.

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Relapse

Recurrence of disease after CR. Relapse is defined as:

If yes, also
complete question
204

> 5% blasts in the marrow
Extramedullary disease
Reappearance of cytogenetic abnormalities and/or
molecular markers associated with the diagnosis at
levels that, as determined by a physician, represent
relapse.

*Sources of disease response definitions:
1) www.uptodate.com
2) http://www.cancer.gov/
3) www.jco.ascopubs.org Cheson 21(24):4642-4649.

FOR HEMATOLOGIC CR
Questions 201-203: For hematologic CR
Hematologic CR includes all the criteria listed for CR above. For recipients who achieve
a hematologic CR, indicate in questions 193-195 if the response also qualified as a
cytogenetic or molecular remission.
Question 201: Cytogenetic remission
Cytogenetic assessment involves testing blood or bone marrow for the presence of
known cytogenetic abnormalities that reflect the recipient’s disease. FISH is categorized
with cytogenetics. Although often used for finding specific features in DNA, FISH is not
as sensitive as molecular methods, even though the markers identified may be the
same.
Cytogenetic remission is a treatment response where both of the following criteria are
met:
The karyotype reverts to normal, and
There are no clonal chromosomal abnormalities detected in the blood and/or
marrow.
If cytogenetic abnormalities associated with the recipient’s disease were identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If cytogenetic abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No cytogenetic assessments were performed.
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Cytogenetic abnormalities associated with the recipient’s disease were identified
previously and no cytogenetic assessment was performed prior to the start of the
preparative regimen.
Cytogenetic abnormalities associated with the recipient’s disease were not
identified on previous testing and no cytogenetic abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 202: 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 testing 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).
If molecular abnormalities associated with the recipient’s disease were identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If molecular abnormalities associated with the recipient’s disease were identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No molecular assessments were performed.
Molecular abnormalities associated with the recipient’s disease were identified
previously and no molecular assessment was performed prior to the start of the
preparative regimen.
Molecular abnormalities associated with the recipient’s disease were not
identified on previous testing and no molecular abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 203: Number
Indicate the number of this hematologic CR.
FOR RELAPSE
Question 204: 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 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.

Chronic Myelogenous Leukemia (CML)
Question 205: 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, report under “Other
Leukemias” and give “Atypical chronic myeloid leukemia” as the detailed disease
classification (questions 235-237).
Table 3. CML Classification Requirements
Definition

Term

Philadelphia chromosome
t(9;22)(q34;q11)

An exchange of genetic material
between region q34 of chromosome 9
and region q11 of chromosome 22.

Complex variation

Translocation of three or more
chromosomes, one of which must be
chromosome 22 [e.g., t(3; 9; 22)].

Variant form

Any translocation involving 22q11, or
22.q11.2 in which CML is the
suspected diagnosis [e.g., t(13;
22)(p3;q11)].

Question 206: 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 207. If the recipient did not receive therapy to treat CML, check
“no” and continue with question 215.
NOTE: Questions 207-214
FormsNet2 application: Check either “yes” or “no” for each option listed.
Paper form submission: Check all that apply.
TM

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Questions 207-214: 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 215-220: Status at Transplantation
Indicate the disease status of CML immediately prior to the start of the preparative
regimen.
Disease
Response: Phase

Definition

Hematologic
Complete
Remission (CR)

A treatment response where all of the following criteria are
met:

If yes, also
complete questions
216-218 and 221

White blood count is < 10 x 109/L, without immature
granulocytes and with < 5% basophils.
Platelet count < 450 x 109/L.
Non-palpable spleen.

Chronic Phase
If yes, also
complete questions
219-221
Accelerated
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 recipient and the treatment received.
One or more of the following must be present:
10%-19% blasts in blood or marrow

If yes, also
complete question
221

≥ 20% basophils in peripheral blood
Clonal marrow cytogenetic abnormalities in addition to
the single Philadelphia chromosome (clonal evolution)
Increasing spleen size, unresponsive to therapy
Increasing WBC, unresponsive to therapy
Thrombocytopenia (platelets < 100,000), unrelated to
therapy
Thrombocytosis (platelets > 1,000,000), unresponsive
to therapy

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Blast Crisis
If yes, also
complete question
221

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

FOR HEMATOLOGIC CR
NOTE:
Question 216 is not required for EBMT centers.
Question 216: 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)
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. Having extramedullary blastic infiltrates (i.e., myeloid
sarcoma, granulocytic sarcoma, or chloroma) also qualifies as blast phase. The
red cell, platelet, and neutrophil counts may decrease, and episodes of infection
and bleeding may result. Symptoms such as fatigue, shortness of breath,
abdominal pain, bone pain, and spleen enlargement may occur. Blast crisis is
similar to acute leukemia in its signs and its effects on the recipient, and can
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involve lymphoid or myeloid lineages (so-called lymphoid blast crisis or myeloid
blast crisis).
Questions 217-218: Indicate if the response also qualified as a cytogenetic or
molecular remission.
Question 217: 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%
If the recipient had a “complete” cytogenetic response at the last evaluation prior to the
start of the preparative regimen, indicate “complete.”
If the recipient had a “partial,” “minor,” “minimal,” or “none” cytogenetic response at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No cytogenetic assessments were performed.
The Philadelphia chromosome associated with the recipient’s disease was
identified previously and no cytogenetic assessment was performed prior to the
start of the preparative regimen.
The Philadelphia chromosome associated with the recipient’s disease was not
identified on previous testing and no cytogenetic abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 218: Molecular remission
PCR testing reveals no molecular evidence of the BCR-ABL fusion gene in the blood
(e.g., BCR-ABL transcript is non-detectable and non-quantifiable in an assay that has at
least 4-5 log range of detection).
Molecular remission is a treatment response in which no minimal residual disease in the
blood and/or marrow can be detected by molecular methods (e.g., PCR).

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If the BCR-ABL fusion gene associated with the recipient’s disease was identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If the BCR-ABL fusion gene associated with the recipient’s disease was identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No molecular assessments for the BCR-ABL fusion gene were performed.
The BCR-ABL fusion gene associated with the recipient’s disease was identified
previously, but no molecular assessment was performed prior to the start of the
preparative regimen
The BCR-ABL fusion gene associated with the recipient’s disease was not
identified on previous testing and the BCR-ABL fusion gene was not identified at
the last evaluation prior to the start of the preparative regimen.
FOR CHRONIC PHASE
Questions 219-220: Indicate if the response also qualified as a cytogenetic or
molecular remission.
Question 219: 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%
If the recipient had a “complete” cytogenetic response at the last evaluation prior to the
start of the preparative regimen, indicate “complete.”
If the recipient had a “partial,” “minor,” “minimal,” or “none” cytogenetic response at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No cytogenetic assessments were performed.
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The Philadelphia chromosome associated with the recipient’s disease was
identified previously and no cytogenetic assessment was performed prior to the
start of the preparative regimen.
The Philadelphia chromosome associated with the recipient’s disease was not
identified on previous testing and no cytogenetic abnormalities were identified at
the last evaluation prior to the start of the preparative regimen.
Question 220: Molecular remission
PCR testing reveals no molecular evidence of the BCR-ABL fusion gene in the blood
(e.g., BCR-ABL transcript is non-detectable and non-quantifiable in an assay that has at
least 4-5 log range of detection).
If the BCR-ABL fusion gene associated with the recipient’s disease was identified
previously and the criteria above were met at the last evaluation prior to the start of the
preparative regimen, indicate “yes.”
If the BCR-ABL fusion gene associated with the recipient’s disease was identified at the
last evaluation prior to the start of the preparative regimen, indicate “no.”
Indicate “unknown” if one of the following applies:
No molecular assessments for the BCR-ABL fusion gene were performed.
The BCR-ABL fusion gene associated with the recipient’s disease was identified
previously, but no molecular assessment was performed prior to the start of the
preparative regimen
The BCR-ABL fusion gene associated with the recipient’s disease was not
identified on previous testing and the BCR-ABL fusion gene was not identified at
the last evaluation prior to the start of the preparative regimen.
Question 221: Status at Transplantation – Number
Indicate the number of the disease phase reported in question 215.

Myelodysplastic (MDS) or Myeloproliferative Diseases (MPS)
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 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.
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Question 222: Classification, specify at diagnosis
Indicate the recipient’s disease classification at diagnosis.
Question 223: Status at transplantation
Indicate the recipient’s disease classification immediately prior to the start of the
preparative regimen.
If MDS or MPS transformed to AML, continue to question 224 and complete both the
MDS and the AML Disease Classification Sheets.
Question 224: If AML, date of MDS diagnosis
If MDS or MPS transformed into AML between the initial diagnosis and the start of the
preparative regimen, enter the MDS or MPS diagnosis date. (Report the AML diagnosis
date in question 2.) Report the date of the first pathological diagnosis (e.g., bone
marrow biopsy) of MDS/MPS. Enter the date the sample was collected for examination.
If the diagnosis was determined at an outside center and no documentation of a
pathological or laboratory assessment is available, the dictated date of diagnosis within
a physician note may be reported. Do not report the date symptoms first appeared.
NOTE:
Question 225 should only be answered if the recipient is being transplanted for a
chronic myeloproliferative disease (MPS).
Question 225: 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 tumor survival. If the JAK2 testing was positive at
any time prior to the start of the preparative regimen, report “yes.” If the JAK2 testing
was negative, report “no.” If JAK2 testing was not performed, report “not done.”
Questions 226: Was MDS/MPS therapy related?
Agents such as radiation or systemic therapy used to treat other diseases (e.g.,
Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, and breast cancer) can damage the
marrow and lead to a secondary malignancy, such as MDS/MPS. If the diagnosis of
MDS/MPS is therapy-related, check “yes” and continue with question 227. If the
diagnosis of MDS/MPS is not therapy-related, check “no” and continue with question
230. If it is not known whether the MDS/MPS diagnosis is therapy-related, check
“unknown” and continue with question 230.
Questions 227-229: MDS, therapy related
Indicate the therapy associated with the diagnosis of MDS/MPS.
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MDS/MPS/Chronic Myelomonocytic Leukemia (CMML)
Questions 230-233: Status at Transplantation
Indicate the disease status of MDS/MPS/CMML immediately prior to the start of the
preparative regimen.
NOTE:
MDS/MPS/CMML to AML transformation
If the recipient is being transplanted for AML that has transformed from
MDS/MPS/CMML, the status at transplantation (questions 230-233) should be left
blank. Override these errors in the FormsNet2™ application and complete the Disease
Classification Sheet for AML.

Disease Status

Definition

Supportive care or
treatment without
chemotherapy

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

Treated with
chemotherapy*

Examples of this status include but are not limited to:

If yes, also
complete questions
231-232

Low intensity chemotherapy including cytarabine,
azacitidine (Vidaza®), and decitabine (Dacogen®)
High intensity chemotherapy that may include
aggressive antileukemic therapy such as a
combination of cytarabine and idarubicin

Relapsed after CR* A treatment response where one or more of the following
criteria are met:
If yes, also
complete questions
233

Return to pre-treatment bone marrow blast
percentage
Decrease of ≥ 50% from maximum response

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levels in granulocytes or platelets
Transfusion dependence or hemoglobin level
≥ 1.5g/dL lower than prior to therapy
*Source of disease response definition: CIBMTR Pre-HSCT MDS/MPS Disease Form 2014

FOR RECIPIENTS TREATED WITH CHEMOTHERAPY
Question 231: Status at Transplantation, specify
From the options listed below, indicate the recipient’s disease status immediately prior
to the start of the preparative regimen.
Disease Status

Definition

Complete
Remission (CR)

A treatment response where all of the following criteria are
met and maintained for ≥ 4 weeks*:

If yes, also
complete question
232.

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 documented to be in CR, report the status at
transplantation as CR. Important: if within four weeks
following transplant the recipient’s status is determined to
not be CR, an Error Correction Form must be submitted
changing the pre-HSCT status.

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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
8 weeks by ≥ 4 units compared to the pretreatment transfusion number in the
previous 8 weeks

Improvement, but
no CR (cont.)

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 that has 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

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FOR CR
Question 232: Number
Indicate the number of this CR.
FOR RELAPSED FROM CR
Question 233: 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.

Juvenile Myelomonocytic Leukemia (JMML)
NOTE:
JMML to AML transformation
If the recipient is being transplanted for AML that has transformed from JMML, the
status at transplantation (question 234) should be left blank. Override this error in the
FormsNet2™ application and complete the Disease Classification Sheet for AML.
Question 234: Status at Transplantation
Indicate the recipient’s disease status of JMML immediately prior to the start of the
preparative regimen.
Disease Status

Definition

Continued
Complete
Response (CCR)*

Recipient achieved CR and has remained in CR. Continued
absence of all known disease after achieving CR following a
previous line of therapy.

Complete
Response (CR)*

Characterized by normalization of WBC and organomegaly.

Partial Response
(PR)*

≥ 50% reduction in WBC and/or organomegaly.

Minimal Response
(MR)*

Requires one or more of the following:
25%-50% reduction in WBC and organomegaly
Partial response in WBC but no change in

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organomegaly
Partial response in organomegaly but no change in
WBC
Stable Disease
(SD)*

≤ 25% reduction in WBC and/or organomegaly.

Progressive
Disease (PD)*

Characterized by an increase in WBC and/or organomegaly.

Not Assessed*

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 235-236: 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 237: Status at Transplantation
Each disease classification has different criteria for disease status. Use the diseasespecific criteria listed in the tables below to determine the recipient’s disease status
immediately prior to the start of the preparative regimen.
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; < 2% basophils, and < 10% monocytes.
Disease Status

Definition

Never Treated

The recipient was diagnosed with atypical CML
and never treated.

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Complete Remission
(CR)

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,
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.

Complete Remission
(CR) (cont.)

Include recipients with persistent cytogenetic
abnormalities who otherwise meet all the criteria of
CR.
Do not include recipients with extramedullary
disease. They should be considered to have
persistent disease, or to be in relapse.

Nodular Partial
Remission (nPR)

Not applicable for atypical CML.

Partial Remission
(PR)

Not applicable for atypical CML.

No Response/Stable
Disease (NR/SD)

The recipient was treated for atypical CML 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.

Progression

Not applicable for atypical CML.

Relapse (untreated)

Recurrence of disease after CR. Relapse is
defined as:

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> 5% blasts in the marrow
Extramedullary disease
Reappearance of cytogenetic abnormalities
and/or molecular markers associated with
the diagnosis at levels that, as determined
by a physician, represent relapse.
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

Definition

Never Treated

The recipient was diagnosed with CLL and never
treated.

Complete Remission
(CR)*

Requires all the following:
No radiographic evidence of
lymphadenopathy
No organomegaly
Neutrophils > 1.5 x 109/L
Platelets > 100 x 109/L
Hemoglobin >11g/dL
Lymphocytes < 4 x 109/L/L
Bone marrow < 30% lymphocytes
Absence of constitutional symptoms (e.g.,
fatigue, fevers, night sweats)

Nodular Partial
Remission (nPR)*

Complete response with persistent lymphoid
nodules in bone marrow.

Partial Remission
(PR)*

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

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enlarged pretreatment
AND one or more of the following:
Neutrophils ≥ 1.5x109/L or 50% above
baseline
Platelets > 100x109/L or 50% improvement
over baseline
Hemoglobin > 11.0 g/dL or 50%
improvement over baseline
No Response/Stable
Disease (NR/SD)*

No change. Not complete response, partial
response, or progressive disease.

Progression*

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

Relapse (untreated)

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

Definition

Never Treated

The recipient was diagnosed with hairy cell
leukemia and never treated.

Complete Remission
(CR)*

Disappearance of all evidence of disease.
Requires all of the following:
Neutrophils ≥ 1.5 x 109

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Hemoglobin ≥ 12.0 g/dL
Platelets ≥ 100 x 109/L
Absence of hairy cells on peripheral blood
smear
No palpable lymphadenopathy or
hepatosplenomegaly
Nodular Partial
Remission (nPR)

Not applicable for hairy cell leukemia.

Partial Remission
(PR)*

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

No Response/Stable
Disease (NR/SD)

Not applicable for hairy cell leukemia.

Progression

Not applicable for hairy cell leukemia.

Relapse (untreated)*

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

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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

Definition

Never Treated

The recipient was diagnosed with PLL and never
treated.

Complete Remission
(CR)*

Requires all the following:
No radiographic evidence of
lymphadenopathy
No organomegaly
Neutrophils > 1.5 x 109/L
Platelets > 100 x 109/L
Hemoglobin > 11g/dL
Lymphocytes < 4 x 109/L/L
Bone marrow < 30% lymphocytes
Absence of constitutional symptoms (e.g.,
fatigue, fevers, night sweats)

Nodular Partial
Remission (nPR)*

Complete response with persistent lymphoid
nodules in bone marrow.

Partial Remission
(PR)*

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
AND one or more of the following:

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Neutrophils ≥ 1.5x109/L or 50% above
baseline
Platelets > 100x109/L or 50% improvement
over baseline
Hemoglobin > 11.0 g/dL or 50%
improvement over baseline
No Response/Stable
Disease (NR/SD)*

No change. Not complete response, partial
response, or progressive disease.

Progression*

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

Relapse (untreated)

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.

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’s Lymphoma
section.
NOTE: Precursor T- and Precursor B-cell Lymphoblastic Lymphoma/Leukemia
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Due to the aggressive nature of precursor T- and precursor B-cell lymphoblastic
lymphoma (or lymphoma/leukemia), the primary disease reported for recipients with
these malignancies should be acute lymphoblastic leukemia (precursor T-cell ALL or
precursor B-cell ALL).
Hodgkin’s Lymphoma (HL) and Non-Hodgkin’s 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’s Lymphoma
Question 238: Specify disease type
Indicate the disease classification at diagnosis.
Questions 239-243: Status at Transplantation
Indicate the recipient’s disease status immediately prior to the start of the preparative
regimen.
Disease Status

Definition

Never Treated

The recipient was diagnosed with HL and never treated.

Primary Refractory
(less than PR to
initial therapy)/PIF
res

The response of the lymphoma to treatment is less than in a partial
response (PR). This status would also include recipients who
achieved a prior PR (but never CR) but are not in either PR or relapse
immediately prior to transplant.

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Reductions of ≥ 50% in greatest diameter of all sites of known disease
and no new sites.

Partial Response
(PR)*
If yes, also complete
question 240

Complete disappearance of all known disease for ≥ 4 weeks.

Complete
Remission (CR)
Confirmed*
If yes, also complete
question 241

Complete disappearance of all known disease for ≥ 4 weeks with the
exception of persistent scan abnormalities of unknown significance.

CR Unconfirmed
(CRU)*
If yes, also complete
question 241
Relapse (Rel)
If yes, also complete
questions 242-243

Recurrence of disease after CR. This may involve an increase in size
of known disease or new sites of disease.

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

FOR PR
Question 240: 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. Note: “with prior CR” is analogous to
relapse-sensitive (Rel sen). Report PR that included a prior CR in the relapse-sensitive
category and indicate which relapse (number) the recipient is in.
FOR CR/CRu
Question 241: Number
Indicate the number of this CR.
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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FOR RELAPSE
Question 242: 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 243: 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)

Non-Hodgkin’s Lymphoma
Question 244: 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 FormsNet2™ application, select the appropriate grade at diagnosis.
If Non-Hodgkin’s Lymphoma transforms from one subtype to another, report the most
current subtype. Report the initial diagnosis date of the first subtype in Question 2.
Question 245: 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 FormsNet2™.
Question 246: Other B-cell lymphoma, specify
This category should be used only if the recipient’s disease does not fit one of the other
B-cell options listed (e.g., B-cell lymphoma, unclassifiable with a feature between large
B-cell lymphoma and Burkitt’s lymphoma).
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Question 247: 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.
Questions 248-252: Status at Transplantation
Indicate the recipient’s disease status immediately prior to the start of the preparative
regimen.
Disease Status

Definition

Never Treated

The recipient was diagnosed with NHL and never treated.

Primary Refractory
(less than PR to
initial therapy)/PIF
res

The response of the lymphoma to treatment is less than in a
partial response (PR). This status would also include recipients
who achieved a prior PR (but never CR) but are not in either PR
or relapse immediately prior to transplant.

Partial Response
(PR)*

Reductions of ≥ 50% in greatest diameter of all sites of known
disease and no new sites.

If yes, also
complete question
249
Complete
Remission (CR)
Confirmed*

Complete disappearance of all known disease for greater than or
equal to four weeks.

If yes, also
complete question
250
CR Unconfirmed
(CRU)*
If yes, also
complete question
250
Relapse (Rel)
If yes, also
complete questions
251-252

Complete disappearance of all known disease for ≥ 4 weeks with
the exception of persistent scan abnormalities of unknown
significance.*

Recurrence of disease after CR. This may involve an increase in
size of known disease or new sites of disease.

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

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FOR PR
Question 249: 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. Note: “with prior CR” is analogous to
relapse-sensitive (Rel sen). Report PR that included a prior CR in the relapse-sensitive
category and indicate which relapse (number) the recipient is in.
FOR CR/CRu
Question 250: Number
Indicate the number of this CR.
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.
FOR RELAPSE
Question 251: 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 252: 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)

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Plasma Cell Disorders
Plasma cells 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.
Abnormal plasma cells can 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.
For more information regarding multiple myeloma, see the Multiple Myeloma 2016
Manual.
Question 253: Classification
Indicate the disease classification at diagnosis.
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:

Report the disease
diagnosis date of
(Question 2):

Plasmacytoma
transformed to Myeloma

Myeloma

Myeloma

Myeloma and Plasma
Cell Leukemia

Plasma Cell Leukemia

Plasma Cell Leukemia

Myeloma and
Amyloidosis

Myeloma

Myeloma

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If the recipient’s disease classification is one of the following, continue with question
254.
1. Multiple myeloma - IgG
2. Multiple myeloma - IgA
3. Multiple myeloma - IgD
4. Multiple myeloma - IgE
5. Multiple myeloma - IgM (not Waldenstrom macroglobulinemia)
6. Multiple myeloma - light chain only
If the recipient’s disease classification is the following, neither kappa nor lambda light
chains will be present; therefore, continue with question 255 (Durie-Salmon) or question
257 (I.S.S.).
7.

Multiple myeloma - non-secretory

If the recipient’s disease classification is one of the following, continue with question
261.
8.

Plasma cell leukemia

9.

Solitary plasmacytoma (no evidence of myeloma)

10.

Primary amyloidosis

If the recipient’s disease classification is the following, continue with question 260.
11.

Other Plasma Cell Disorder

Question 254: Light Chain
Indicate the presence of light chains as either kappa or lambda.
NOTE: Questions 255-259, Stage at Diagnosis
Report the recipient’s stage at diagnosis using either the Durie-Salmon staging system
(questions 255-256) or the International Staging System (I.S.S.) (questions 257-259).
Questions 255-256: Stage at Diagnosis: Durie-Salmon
Indicate stage and sub-classification. If the Durie-Salmon stage and sub-classification is
not documented in the medical record, see Table 5 below to determine the appropriate
stage and sub-classification.
Table 5. Durie-Salmon Staging System for Multiple Myeloma
Stage

Criteria

I

All of the following:
Hemoglobin >10 g/dL
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Serum calcium normal (≤12 mg/dL)
On radiograph, normal bone structure or solitary bone
plasmacytoma only
Low M-component production rate (IgG < 5 g/dL, IgA <3 g/dL),
Urinary light chain M-component on electrophoresis (<4 g/24 hr)
II

Fitting neither stage I nor stage III

III

One or more of the following:
Hemoglobin < 8.5 g/dL
Serum calcium >12 mg/dL
Advanced lytic bone lesions (scale 3)
High M-component product rate (IgG >7 g/dL, IgA >5 g/dL),
Urinary light chain M-component on electrophoresis (> 12 g/24 hr)

Subclassification

A: Relatively normal renal function (serum creatinine <2.0 mg/dL)
B: Abnormal renal function (serum creatinine ≥2.0 mg/dL)

(either A or B)
Adapted from Durie BG, Salmon SE: A clinical staging system for multiple myeloma: Correlation of
measured myeloma cell mass with presenting clinical features, response to treatment, and survival.
Cancer 1975;36:842-854.

Questions 257-259: Stage at Diagnosis: I.S.S.
Report the recipient’s lab values from diagnosis and/or the stage of myeloma.
Question 260: Other Plasma Cell Disorder, specify
On occasion, a recipient could have two heavy-chain types; this is known as biclonal
myeloma (e.g., IgA Kappa and IgG Kappa). Other examples of “other plasma cell
disorders” include: Light Chain Deposition Disease (LCDD), light chain only myeloma
with associate LCDD, and osteosclerotic myeloma (POEMS). In this instance, report
“other plasma cell disorder” and specify the appropriate type.
In situations of tandem autologous HSCT, oligoclonal reconstitution from a previous
HSCT should not be reported as a new subtype. Oligoclonal reconstitution is the
appearance of a new M-protein not present at diagnosis. For questions regarding
oligoclonal reconstitution, contact your transplant center’s CIBMTR liaison.
Questions 261-262: Status at Transplant
Indicate the recipient’s disease status immediately prior to the start of the preparative
regimen.

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For information regarding reporting multiple myeloma disease status at transplant, see
Appendix V.
Table 6. Disease Status Definitions
Disease Status
Definition
Never Treated
Stringent Complete
Remission (sCR)
If yes, also complete
question 262

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

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Disease Status

Definition

Complete
Remission (CR)

A treatment response where all of the following criteria are met:
Negative immunofixation on serum and urine samples
Disappearance of any soft tissue plasmacytomas
< 5% plasma cells in the bone marrow (confirmation
with repeat bone marrow biopsy not needed)

If yes, also complete
question 262

NOTE: CR Requirements
For recipients with light chain only myeloma, all of the following
criteria must be met:
Normal serum free light chain ratio
Negative immunofixation on urine samples
Disappearance of any soft tissue plasmacytomas
< 5% plasma cells in the bone marrow (confirmation
with repeat bone marrow biopsy not needed)
For recipients with non-secretory myeloma, all of the following
criteria must be met:
Disappearance of all soft tissue plasmacytomas
< 5% plasma cells in the bone marrow (confirmation
with repeat bone marrow biopsy not needed)
CR requires two consecutive assessments (of the same method)
made at any time before the institution of any new therapy. If
radiographic studies were performed, there must be no known
evidence of progressive or new bone lesions. Radiographic
studies are not required to satisfy CR requirements.
Very Good Partial
Response (VGPR)

One or more of the following must be present:

If yes, also complete
question 262

Serum and urine M-protein detectable by
immunofixation but not on electrophoresis
≥ 90% reduction in serum M-protein and urine M-protein
level < 100 mg/24 hours.
VGPR requires two consecutive assessments (of the same
method) made at any time before the institution of any new
therapy. If radiographic studies were performed, there must be no
known evidence of progressive or new bone lesions. Radiographic
studies are not required to satisfy VGPR requirements.

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Disease Status

Definition

Partial Response
(PR)

Both of the following must be present:
≥ 50% reduction in serum M-protein

If yes, also complete
question 262

Reduction in 24-hour urinary M-protein by ≥ 90% or to
< 200 mg/24 hours.
If the serum and urine M-protein are not measurable (i.e., do not
meet the following criteria):
serum M-protein ≥ 1 g/dL,
urine M-protein ≥ 200 mg/24 hours;
then a ≥ 50% decrease in the difference between involved and
uninvolved free light chain levels is required in place of the Mprotein criteria (provided the serum free light chain assay shows
involved level > 10 mg/dL and the serum free light chain is
abnormal).
If serum and urine M-protein and serum-free light assay are not
measurable, a ≥ 50% reduction in bone marrow plasma cells is
required in place of M-protein, provided the baseline bone marrow
plasma cell percentage was ≥ 30%.
In addition to the above listed criteria, a ≥ 50% reduction in the
size of soft tissue plasmacytomas is also required, if present at
baseline.

Stable Disease (SD)

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

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Disease Status

Definition

Progressive Disease
(PD)

Requires one or more of the following:

If yes, also complete
question 262

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

Relapse from CR
(untreated)
If yes, also complete
question 262

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

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

Question 262: Number
Indicate the number of this CR, sCR, VGPR, PR, Progression or Relapse.
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Breast Cancer
Question 263: Classification
Indicate the disease classification at diagnosis as either “inflammatory” or “noninflammatory.”
Inflammatory breast cancer 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).
NOTE: Question 264
If the recipient is considered stage IV, select stage III for question 264, and select
“metastatic” for question 265.
Question 264: 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

Definition

0

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
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Stage

Definition

I

The tumor is no more than 2 cm (¾ inch) across, and the cancer cells
have not spread beyond the breast (T1, N0, M0).

II

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).
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).

III

NOTE
The Pre-TED does not collection the detail of Stage
III.
Locally advanced cancer. Stage III is generally divided into Stage IIIA,
IIIB, and IIIC.
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).

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Stage

Definition

III
(cont.)

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):
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.

IV

Distant metastatic cancer. The cancer has spread to other parts of the
body (including the ipsilateral supraclavicular lymph nodes).

Question 265: 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.
Questions 266-271: Status at Transplant
Indicate the recipient’s disease status immediately prior to the start of the preparative
regimen.
Disease Status

Definition

Adjuvant

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.

(Stage II, III only)

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Disease Status

Definition

Never Treated

Never treated indicates the recipient was not treated for
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.
Complete
Remission*

CR Confirmed: Disappearance of target lesions for a period
of at least one month.

If yes, also
complete questions
267-268

CR Unconfirmed: Complete response with persistent
imaging abnormalities of unknown significance.

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
If yes, also
complete questions
269-271

Recurrence of the disease after CR. Can be local or
metastatic.

*Source of disease response definitions: CIBMTR Pre-HSCT Breast Cancer Disease Form 2020

FOR CR
Question 267: CR, specify
Using the definitions listed above, indicate whether the CR was “confirmed” or
“unconfirmed.” 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 268: CR, number
Indicate the number of this response.
FOR RELAPSE
Question 269: 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 270: 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 271: 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:
Sensitive: ≥ 50% reduction in the bi-dimensional diameter of all disease sites
with no new sites of disease
Resistant: < 50% reduction in the diameter of all disease sites or development of
new disease sites
Untreated: if last treatment was not chemotherapy
Unknown: only if there no documentation of the recipient’s response following
treatment

“Other” Disease
Question 272: 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. Examples include: Composite Lymphoma (e.g., both active NHL and HL),
Erythropoietic Protoporphyria (EPP), and Dystrophic Epidermolysis Bullosa (DEB).

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Question 273: 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 Documents (Form 2800).
NOTE: Alternative HCT
The CIBMTR is currently in the process of updating the Pre-TED form to remove
questions 274-275. Cellular therapies for regenerative medicine (i.e., alternative HCT)
are now captured on Form 4000.
Questions 274-275: 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 for assistance, as the name of the
subtype may have changed.
Questions 276-277: 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.
Questions 278-279: Status at Transplantation
Indicate the recipient’s disease status immediately prior to the start of the preparative
regimen.
Disease Status

WHO Definition

RECIST Definition

Adjuvant

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.

Not applicable

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Disease Status

WHO Definition

Never Treated

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
Complete disappearance of all
Response (CR)
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.
Complete
Disappearance of all signs and
Response
symptoms of disease with
Unconfirmed (CRU) normalization of all biochemical
and radiologic parameters, but with
persistent, unchanging imaging
abnormalities of unknown
significance.
Partial Response
Decrease of ≥ 50% in total tumor
(PR)
load of the lesions that have been
Partial Response
measured for at least 4 weeks.
(PR) (cont.)
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.

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

What is important to CIBMTR data
analysis is to distinguish the type
of PR as either: “without prior CR”
or “with prior CR.”
Question 279: Specify
If the recipient is in a partial response, indicate whether
there was a previous CR.

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Disease Status

WHO Definition

RECIST Definition

No
Response/Stable
Disease (NR/SD)

Disease has been treated and the
size of one or more lesions has
neither increased 25% or more in
the size of one or more lesions,
nor has total tumor size decreased
50% or more.

Progressive
Disease (PD)

Increase of ≥ 20% in the size of
one or more measurable lesions,
or the appearance of new lesions.

Relapse
(untreated)

The reappearance of disease after
complete recovery. Should be
determined by one or more
diagnostic tests.

Neither sufficient
shrinkage to qualify
for PR nor sufficient
increase to qualify
for PD, taking as
reference the
smallest sum of the
longest diameter of
measured lesions
(target lesions),
since the treatment
started.
At least a 20%
increase in the sum
of the longest
diameter of
measured lesions
(target lesions),
taking as reference
the smallest sum
longest diameter
recorded since the
treatment started or
the appearance of
one or more new
lesions.
Not applicable.

Question 280: Was Response Evaluation Criteria in Solid Tumors (RECIST)
criteria 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 281: Number (complete for CR, CRU or relapse)
Indicate which number the response represents.

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Question 282: REL, sensitivity to chemotherapy (complete only for relapse)
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. Indicate the 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
Resistant: < 50% reduction in the diameter of all disease sites or development of
new disease sites
Untreated: if last treatment was not chemotherapy
Unknown: only if there no documentation of the recipient’s response following
treatment
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 283-287: Classification
Indicate the disease classification at diagnosis.

Platelet Disorders
Questions 288-289: Classification
Indicate the disease classification at diagnosis.

Histiocytic Disorders
Questions 290-291: Classification
Indicate the disease classification at diagnosis.
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Inherited Disorders of Metabolism/Osteopetrosis
Questions 292-293: Classification
Indicate the disease classification at diagnosis.

Immune Deficiencies
Questions 294-296: 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 297: Autoimmune Deficiencies, Specify
Indicate the disease classification at diagnosis.

Systemic Sclerosis (Connective Tissue Disease)
Questions 298-321: 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 322-324: 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)
Questions 325-351: 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.

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Questions 352-358: Miscellaneous Labs at Original Diagnosis
For each test listed, indicate whether the result was “normal,” “elevated or low,” or “not
done.”

Sjögren Syndrome (Connective Tissue Disease)
Questions 359-371: 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)
Questions 372-386: 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 387-390: Miscellaneous Labs at Diagnosis
For each test listed, indicate whether the result was “normal,” “elevated,” or “not done.”

Antiphospholipid Syndrome (Connective Tissue Disease)
Questions 391-406: 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 407-409: Miscellaneous Labs at Diagnosis
For each test listed, indicate whether the result was “normal,” “elevated,” or “not done.”

Other Connective Tissue Disease
Question 410: Other connective tissue disease, specify:
Specify the other connective tissue disease classification at the time of original
diagnosis.

Wegener Granulomatosis (Vasculitis)
Questions 411-422: 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.
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Questions 423-427: Miscellaneous Labs at Diagnosis
For each antibody listed, indicate whether the result was “normal,” “elevated,” or “not
done.”

Polyarteritis Nodosa, Classical and Microscopic (Vasculitis)
Questions 428-441: 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 442-444: Miscellaneous Labs at Diagnosis
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.

Other Vasculitis
Question 445: Other vasculitis, specify
Specify the other vasculitis disease classification at the time of original diagnosis.

Rheumatoid Arthritis
Questions 446-460: 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
Questions 461-467: 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.

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Juvenile Idiopathic Arthritis: systemic (Stills disease), Oligoarticular,
Polyarticular
If the recipient’s primary disease is listed in the box above, check the appropriate
disease.

Juvenile Idiopathic Arthritis: Other
Question 468: Juvenile idiopathic arthritis: other, specify
Specify the other juvenile idiopathic arthritis disease classification at the time of original
diagnosis.

Other Arthritis
Question 469: Other arthritis, specify
Specify the other arthritis disease classification at the time of original diagnosis.

Multiple Sclerosis
Questions 470-478: 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.

Other Autoimmune Neurological Disorder
Question 479: 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.

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Other Autoimmune Cytopenia
Question 480: 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.

Other Autoimmune Bowel Disorder
Question 481: Other autoimmune bowel disorder, specify
Indicate the disease at the time of original diagnosis.

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