2-2 Draft 2402 R6 Disease Classification 2

Legend: update addition

Disease Classification

OMB No: 0915-0310

Expiration Date: 10/31/2022

Public Burden Statement: The purpose of the data collection is to fulfill the legislative mandate to establish and maintain a standardized database of allogeneic marrow and cord blood transplants performed in the United States or using a donor from the United States. The data collected also meets the C.W. Bill Young Cell Transplantation Program requirements to provide relevant scientific information not containing individually identifiable information available to the public in the form of summaries and data sets. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0310 and it is valid until 10/31/2022. This information collection is voluntary under The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109–129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2010, Public Law 111–264 (the Act) and the Stem Cell Therapeutic and Research Reauthorization Act of 2015, Public Law 114-104. Public reporting burden for this collection of information is estimated to average 0.43 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or [email protected].

Registry Use Only

Sequence Number:

Date Received:

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Event date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Primary Disease for HCT / Cellular Therapy

1. Date of diagnosis of primary disease for HCT / cellular therapy: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

2. What was the primary disease for which the HCT / cellular therapy was performed?

• Acute myelogenous leukemia (AML or ANLL) (10) - Go to question 3

• Acute lymphoblastic leukemia (ALL) (20) - Go to question 96

• Acute leukemia of ambiguous lineage and other myeloid neoplasms (80) - Go to question 164

• Chronic myelogenous leukemia (CML) (40) - Go to question 168

• Myelodysplastic Syndrome (MDS) (50) (If recipient has transformed to AML, indicate AML as the primary disease.) - Go to question 179

• Myeloproliferative Neoplasms (MPN) (1460) (If recipient has transformed to AML, indicate AML as the primary disease.) - Go to question 259

• Other leukemia (30) (includes CLL) - Go to question 372

• Hodgkin lymphoma (150) - Go to question 379

• Non-Hodgkin lymphoma (100) - Go to question 379

• Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 397

• Solid tumors (200) - Go to question 444

• Aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease.) - Go to question 446

• Inherited bone marrow failure syndromes (320) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease.)– Go to question 449

• Hemoglobinopathies (330) - Go to question 451

• Paroxysmal nocturnal hemoglobinuria (PNH) (340) – Go to signature line

• Disorders of the immune system (400) - Go to question 488

• Inherited abnormalities of platelets (500) - Go to question 496

• Inherited disorders of metabolism (520) - Go to question 498

• Histiocytic disorders (570) - Go to question 501

• Autoimmune diseases (600) - Go to question 506

• Tolerance induction associated with solid organ transplant (910) - Go to question 510

• Recessive dystrophic epidermolysis bullosa (920) – Go to First Name

• Other disease (900) - Go to question 512

Acute Myelogenous Leukemia (AML)

3. Specify the AML classification

AML with recurrent genetic abnormalities

• AML with t(9;11) (p22.3;q23.3); MLLT3-KMT2A (5)

• AML with t(6;9) (p23;q34.1); DEK-NUP214 (6)

• AML with inv(3) (q21.3;q26.2) or t(3;3) (q21.3;q26.2); GATA2, MECOM (7)

• AML (megakaryoblastic) with t(1;22) (p13.3;q13.3); RBM15-MKL1 (8)

• AML with t(8;21); (q22; q22.1); RUNX1-RUNX1T1 (281)

• AML with inv(16) (p13.1;1q22) or t(16;16)(p13.1; q22); CBFB-MYH11 (282)

• APL with PML-RARA (283)

• AML with BCR-ABL1 (provisional entity) (3)

• AML with mutated NPM1 (4)

• AML with biallelic mutations of CEBPA (297)

• AML with mutated RUNX1 (provisional entity) (298)

• AML with 11q23 (MLL) abnormalities (i.e., t(4;11), t(6;11), t(9;11), t(11;19)) (284)

• AML with myelodysplasia – related changes (285)

• Therapy related AML (t-AML) (9)

AML, not otherwise specified

• AML, not otherwise specified (280)

• AML, minimally differentiated (286)

• AML without maturation (287)

• AML with maturation (288)

• Acute myelomonocytic leukemia (289)

• Acute monoblastic / acute monocytic leukemia (290)

• Acute erythroid leukemia (erythroid / myeloid and pure erythroleukemia) (291)

• Acute megakaryoblastic leukemia (292)

• Acute basophilic leukemia (293)

• Acute panmyelosis with myelofibrosis (294)

• Myeloid sarcoma (295)

• Myeloid leukemia associated with Down syndrome (299)

3. Did AML transform from MDS or MPN?

• Yes – Also complete MDS or MPN Disease Classification questions

• No

3. Is the disease (AML) therapy related?

• Yes

• No

• Unknown

3. Did the recipient have a predisposing condition?

• Yes - Go to question 7

• No - Go to question 9

• Unknown - Go to question 9

3. Specify condition

• Bloom syndrome - Go to question 9

• Down syndrome - Go to question 9

• Fanconi anemia - Also complete CIBMTR Form 2029 - Go to question 9

• Dyskeratosis congenita - Go to question 9

• Other condition - Go to question 8

3. Specify other condition: __________________________________________

Labs at diagnosis

3. Were cytogenetics tested (karyotyping or FISH)? (at diagnosis)

• Yes - Go to question 10

• No - Go to question 23

• Unknown - Go to question 23

3. Were cytogenetics tested via FISH?

• Yes – Go to question 11

• No - Go to question 16

3. Results of tests

• Abnormalities identified – Go to question 12

• No abnormalities - Go to question 16

Specify cytogenetic abnormalities identified at diagnosis

3.  International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ___________________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• -5

• -7

• -17

• -18

• -X

• -Y

• +4

• +8

• +11

• +13

• +14

• +21

• +22

• t(3;3)

• t(6;9)

• t(8;21)

• t(9;11)

• t(9;22)

• t(15;17) and variants

• t(16;16)

• del(3q) / 3q–

• del(5q) / 5q–

• del(7q) / 7q–

• del(9q) / 9q–

• del(11q) / 11q–

• del(16q) / 16q–

• del(17q) / 17q–

• del(20q) / 20q–

• del(21q) / 21q–

• inv(3)

• inv(16)

• (11q23) any abnormality

• 12p any abnormality

• Other abnormality - Go to question 15

3. Specify other abnormality: _____________________

4. Were cytogenetics tested via karyotyping?

• Yes – Go to question 17

• No - Go to question 22

3. Results of tests

• Abnormalities identified – Go to question 18

• No evaluable metaphases - Go to question 22

• No abnormalities - Go to question 22

Specify cytogenetic abnormalities identified at diagnosis

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _____________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• -5

• -7

• -17

• -18

• -X

• -Y

• +4

• +8

• +11

• +13

• +14

• +21

• +22

• t(3;3)

• t(6;9)

• t(8;21)

• t(9;11)

• t(9;22)

• t(15;17) and variants

• t(16;16)

• del(3q) / 3q–

• del(5q) / 5q–

• del(7q) / 7q–

• del(9q) / 9q–

• del(11q) / 11q–

• del(16q) / 16q–

• del(17q) / 17q–

• del(20q) / 20q–

• del(21q) / 21q–

• inv(3)

• inv(16)

• (11q23) any abnormality

• 12p any abnormality

• Other abnormality - Go to question 21

3. Specify other abnormality: _____________________

4. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)

• Yes

• No

3. Were tests for molecular markers performed? (e.g. PCR, NGS) (at diagnosis)

• Yes – Go to question 24

• No – Go to question 36

• Unknown – Go to question 36

Specify molecular markers identified at diagnosis

3. CEBPA

• Positive – Go to question 25

• Negative - Go to question 26

• Not done - Go to question 26

3. Specify CEBPA mutation

• Biallelic (homozygous)

• Monoallelic (heterozygous)

• Unknown

3. FLT – TKD (point mutations in D835 or deletions of codon I836)

• Positive

• Negative

• Not done

3. FLT3 – ITD mutation

• Positive- Go to question 28

• Negative- Go to question 30

• Not done- Go to question 30

3. FLT3 – ITD allelic ratio

• Known - Go to question 29

• Unknown - Go to question 30

3. Specify FLT3 - ITD allelic ratio: ___ . ___ ___

4. IDH1

• Positive

• Negative

• Not done

3. IDH2

• Positive

• Negative

• Not done

3. KIT

• Positive

• Negative

• Not done

3. NPM1

• Positive

• Negative

• Not done

3. Other molecular marker

• Positive- Go to question 35

• Negative- Go to question 35

• Not done- Go to question 36

3. Specify other molecular marker: _________________________________

Copy and complete questions 34-35 for multiple molecular markers

Labs between diagnosis and last evaluation

3. Were cytogenetics tested (karyotyping or FISH)? (between diagnosis and last evaluation)

• Yes - Go to question 37

• No - Go to question 50

• Unknown - Go to question 50

3. Were cytogenetics tested via FISH?

• Yes – Go to question 38

• No - Go to question 43

3. Results of tests

• Abnormalities identified – Go to question 39

• No abnormalities - Go to question 43

Specify cytogenetic abnormalities identified between diagnosis and last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ____________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• -5

• -7

• -17

• -18

• -X

• -Y

• +4

• +8

• +11

• +13

• +14

• +21

• +22

• t(3;3)

• t(6;9)

• t(8;21)

• t(9;11)

• t(9;22)

• t(15;17) and variants

• t(16;16)

• del(3q) / 3q–

• del(5q) / 5q–

• del(7q) / 7q–

• del(9q) / 9q–

• del(11q) / 11q–

• del(16q) / 16q–

• del(17q) / 17q–

• del(20q) / 20q–

• del(21q) / 21q–

• inv(3)

• inv(16)

• (11q23) any abnormality

• 12p any abnormality

• Other abnormality - Go to question 42

3. Specify other abnormality: _____________________

4. Were cytogenetics tested via karyotyping?

• Yes – Go to question 44

• No - Go to question 49

3. Results of tests

• Abnormalities identified – Go to question 45

• No evaluable metaphases - Go to question 49

• No abnormalities - Go to question 49

Specify cytogenetic abnormalities identified between diagnosis and last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ___________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• -5

• -7

• -17

• -18

• -X

• -Y

• +4

• +8

• +11

• +13

• +14

• +21

• +22

• t(3;3)

• t(6;9)

• t(8;21)

• t(9;11)

• t(9;22)

• t(15;17) and variants

• t(16;16)

• del(3q) / 3q–

• del(5q) / 5q–

• del(7q) / 7q–

• del(9q) / 9q–

• del(11q) / 11q–

• del(16q) / 16q–

• del(17q) / 17q–

• del(20q) / 20q–

• del(21q) / 21q–

• inv(3)

• inv(16)

• (11q23) any abnormality

• 12p any abnormality

• Other abnormality - Go to question 48

3. Specify other abnormality: _____________________

4. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)

• Yes

• No

3. Were tests for molecular markers performed? (e.g. PCR, NGS) (between diagnosis and last evaluation)

• Yes – Go to question 51

• No – Go to question 63

• Unknown – Go to question 63

Specify molecular markers identified between diagnosis and last evaluation

3. CEBPA

• Positive – Go to question 52

• Negative - Go to question 53

• Not done - Go to question 53

3. Specify CEBPA mutation

• Biallelic (homozygous)

• Monoallelic (heterozygous)

• Unknown

3. FLT – TKD (point mutations in D835 or deletions of codon I836)

• Positive

• Negative

• Not done

3. FLT3 – ITD mutation

• Positive- Go to question 55

• Negative- Go to question 57

• Not done- Go to question 57

3. FLT3 – ITD allelic ratio

• Known - Go to question 56

• Unknown - Go to question 57

3. Specify FLT3 - ITD allelic ratio: ___ . ___

4. IDH1

• Positive

• Negative

• Not done

3. IDH2

• Positive

• Negative

• Not done

3. KIT

• Positive

• Negative

• Not done

3. NPM1

• Positive

• Negative

• Not done

3. Other molecular marker:

• Positive- Go to question 62

• Negative- Go to question 62

• Not done- Go to question 63

3. Specify other molecular marker: _________________________________

Copy and complete questions 61-62 to report multiple other molecular markers

Labs at last evaluation

3. Were cytogenetics tested (karyotyping or FISH)? (at last evaluation)

• Yes - Go to question 64

• No - Go to question 77

• Unknown - Go to question 77

3. Were cytogenetics tested via FISH?

• Yes – Go to question 65

• No - Go to question 70

3. Results of tests

• Abnormalities identified – Go to question 66

• No abnormalities - Go to question 70

Specify cytogenetic abnormalities identified at last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ______________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• -5

• -7

• -17

• -18

• -X

• -Y

• +4

• +8

• +11

• +13

• +14

• +21

• +22

• t(3;3)

• t(6;9)

• t(8;21)

• t(9;11)

• t(9;22)

• t(15;17) and variants

• t(16;16)

• del(3q) / 3q–

• del(5q) / 5q–

• del(7q) / 7q–

• del(9q) / 9q–

• del(11q) / 11q–

• del(16q) / 16q–

• del(17q) / 17q–

• del(20q) / 20q–

• del(21q) / 21q–

• inv(3)

• inv(16)

• (11q23) any abnormality

• 12p any abnormality

• Other abnormality - Go to question 69

3. Specify other abnormality: _____________________

4. Were cytogenetics tested via karyotyping?

• Yes – Go to question 71

• No - Go to question 76

3. Results of tests

• Abnormalities identified – Go to question 72

• No evaluable metaphases - Go to question 76

• No abnormalities - Go to question 76

Specify cytogenetic abnormalities identified at last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• -5

• -7

• -17

• -18

• -X

• -Y

• +4

• +8

• +11

• +13

• +14

• +21

• +22

• t(3;3)

• t(6;9)

• t(8;21)

• t(9;11)

• t(9;22)

• t(15;17) and variants

• t(16;16)

• del(3q) / 3q–

• del(5q) / 5q–

• del(7q) / 7q–

• del(9q) / 9q–

• del(11q) / 11q–

• del(16q) / 16q–

• del(17q) / 17q–

• del(20q) / 20q–

• del(21q) / 21q–

• inv(3)

• inv(16)

• (11q23) any abnormality

• 12p any abnormality

• Other abnormality - Go to question 75

3. Specify other abnormality: _____________________

4. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)

• Yes

• No

3. Were tests for molecular markers performed? (e.g. PCR, NGS) (at last evaluation)

• Yes – Go to question 78

• No – Go to question 90

• Unknown – Go to question 90

Specify molecular markers identified at last evaluation

3. CEBPA

• Positive – Go to question 79

• Negative - Go to question 80

• Not done - Go to question 80

3. Specify CEBPA mutation

• Biallelic (homozygous)

• Monoallelic (heterozygous)

• Unknown

3. FLT – TKD (point mutations in D835 or deletions of codon I836)

• Positive

• Negative

• Not done

3. FLT3 – ITD mutation

• Positive- Go to question 82

• Negative- Go to question 84

• Not done- Go to question 84

3. FLT3 – ITD allelic ratio

• Known - Go to question 83

• Unknown - Go to question 84

3. Specify FLT3 - ITD allelic ratio: ___ . ___

4. IDH1

• Positive

• Negative

• Not done

3. IDH2

• Positive

• Negative

• Not done

3. KIT

• Positive

• Negative

• Not done

3. NPM1

• Positive

• Negative

• Not done

3. Other molecular marker

• Positive- Go to question 89

• Negative- Go to question 89

• Not done- Go to question 90

3. Specify other molecular marker: _________________________________

Copy and complete questions 88-89 to report multiple other molecular markers

CNS Leukemia

3. Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen / infusion?

• Yes

• No

• Unknown

Status at transplantation / infusion:

3. What was the disease status? (based on hematological test results)

• Primary induction failure – Go to question 95

• 1st complete remission (no previous bone marrow or extramedullary relapse) (include CRi)– Go to question 92

• 2nd complete remission – Go to question 92

• ≥ 3rd complete remission – Go to question 92

• 1st relapse – Go to question 94

• 2nd relapse – Go to question 94

• ≥ 3rd relapse – Go to question 94

• No treatment – Go to question 95

3. How many cycles of induction therapy were required to achieve 1st complete remission? (includes CRi)

• 1

• 2

• ≥ 3

3. Was the recipient in remission by flow cytometry?

• Yes – Go to question 95

• No – Go to question 95

• Unknown – Go to question 95

• Not applicable – Go to question 95

3. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Acute Lymphoblastic Leukemia (ALL)

3. Specify ALL classification

B-lymphoblastic leukemia / lymphoma

• B-lymphoblastic leukemia / lymphoma, NOS (B-cell ALL, NOS) (191)

• B-lymphoblastic leukemia / lymphoma with t(9;22)(q34.1;q11.2); BCR-ABL1 (192)

• B-lymphoblastic leukemia / lymphoma with t(v;11q23.3); KMT2A rearranged (193)

• B-lymphoblastic leukemia / lymphoma with t(1;19)(q23;p13.3); TCF3-PBX1 (194)

• B-lymphoblastic leukemia / lymphoma with t(12;21) (p13.2;q22.1); ETV6-RUNX1 (195)

• B-lymphoblastic leukemia / lymphoma with t(5;14) (q31.1;q32.3); IL3-IGH (81)

• B-lymphoblastic leukemia / lymphoma with Hyperdiploidy (51-65 chromosomes) (82)

• B-lymphoblastic leukemia / lymphoma with Hypodiploidy (<46 chromosomes) (83)

• B-lymphoblastic leukemia / lymphoma, BCR-ABL1-like (provisional entity) (94)

• B-lymphoblastic leukemia / lymphoma, with iAMP21 (95)

T-cell lymphoblastic leukemia / lymphoma

• T-cell lymphoblastic leukemia / lymphoma (Precursor T-cell ALL) (196)

• Early T-cell precursor lymphoblastic leukemia (96)

NK cell lymphoblastic leukemia / lymphoma

• Natural killer (NK)- cell lymphoblastic leukemia / lymphoma (97)

3. Did the recipient have a predisposing condition?

• Yes - Go to question 98

• No - Go to question 100

• Unknown - Go to question 100

3. Specify condition

• Aplastic anemia - Go to question 100 Also complete CIBMTR Form 2028 — APL

• Bloom syndrome - Go to question 100

• Down syndrome - Go to question 100

• Fanconi anemia - Go to question 100 Also complete CIBMTR Form 2029 — FAN

• Other condition - Go to question 99

3. Specify other condition: _________________________________________

4. Were tyrosine kinase inhibitors given for therapy at any time prior to the start of the preparative regimen / infusion? (e.g. imatinib mesylate, dasatinib, etc.)

• Yes

• No

Laboratory studies at diagnosis

3. Were cytogenetics tested (karyotyping or FISH)? (at diagnosis)

• Yes - Go to question 102

• No - Go to question 115

• Unknown - Go to question 115

3. Were cytogenetics tested via FISH? (at diagnosis)

• Yes - Go to question 103

• No - Go to question 108

3. Results of tests (at diagnosis)

• Abnormalities identified - Go to question 104

• No abnormalities - Go to question 108

Specify cytogenetic abnormalities identified at diagnosis

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ____________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• –7

• +4

• +8

• +17

• +21

• t(1;19)

• t(2;8)

• t(4;11)

• t(5;14)

• t(8;14)

• t(8;22)

• t(9;22)

• t(10;14)

• t(11;14)

• t(12;21)

• del(6q) / 6q–

• del(9p) / 9p–

• del(12p) / 12p–

• add(14q)

• (11q23) any abnormality

• 9p any abnormality

• 12p any abnormality

• Hyperdiploid (> 50)

• Hypodiploid (< 46)

• iAMP21

• Other abnormality – Go to question 107

3. Specify other abnormality: _______________________________

4. Were cytogenetics tested via karyotyping? (at diagnosis)

• Yes - Go to question 109

• No - Go to question 114

3. Results of tests (at diagnosis)

• Abnormalities identified - Go to question 110

• No evaluable metaphases - Go to question 114

• No abnormalities - Go to question 114

Specify cytogenetic abnormalities identified at diagnosis

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: ______________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• –7

• +4

• +8

• +17

• +21

• t(1;19)

• t(2;8)

• t(4;11)

• t(5;14)

• t(8;14)

• t(8;22)

• t(9;22)

• t(10;14)

• t(11;14)

• t(12;21)

• del(6q) / 6q–

• del(9p) / 9p–

• del(12p) / 12p–

• add(14q)

• (11q23) any abnormality

• 9p any abnormality

• 12p any abnormality

• Hyperdiploid (> 50)

• Hypodiploid (< 46)

• iAMP21

• Other abnormality – Go to question 113

3. Specify other abnormality: _________________________

4. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)

• Yes

• No

3. Were tests for molecular markers performed? (e.g. PCR, NGS) (at diagnosis)

• Yes – Go to question 116

• No – Go to question 120

• Unknown – Go to question 120

Specify molecular markers identified at diagnosis

3. BCR / ABL

• Positive

• Negative

• Not done

3. TEL-AML / AML1

• Positive

• Negative

• Not done

3. Other molecular marker

• Positive – Go to question 119

• Negative – Go to question 119

• Not done – Go to question 120

3. Specify other molecular marker: ______________________________

Copy and complete questions 118-119 for additional molecular markers

Laboratory studies between diagnosis and last evaluation

3. Were cytogenetics tested (karyotyping or FISH)? (between diagnosis and last evaluation)

• Yes - Go to question 121

• No - Go to question 134

• Unknown - Go to question 134

3. Were cytogenetics tested via FISH? (between diagnosis and last evaluation)

• Yes - Go to question 122

• No - Go to question 127

3. Results of tests (between diagnosis and last evaluation)

• Abnormalities identified - Go to question 123

• No abnormalities - Go to question 127

Specify cytogenetic abnormalities identified between diagnosis and last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _____________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• –7

• +4

• +8

• +17

• +21

• t(1;19)

• t(2;8)

• t(4;11)

• t(5;14)

• t(8;14)

• t(8;22)

• t(9;22)

• t(10;14)

• t(11;14)

• t(12;21)

• del(6q) / 6q–

• del(9p) / 9p–

• del(12p) / 12p–

• add(14q)

• (11q23) any abnormality

• 9p any abnormality

• 12p any abnormality

• Hyperdiploid (> 50)

• Hypodiploid (< 46)

• iAMP21

• Other abnormality – Go to question 126

3. Specify other abnormality: ___________________________

4. Were cytogenetics tested via karyotyping? (between diagnosis and last evaluation)

• Yes - Go to question 128

• No - Go to question 133

3. Results of tests (between diagnosis and last evaluation)

• Abnormalities identified - Go to question 129

• No evaluable metaphases - Go to question 133

• No abnormalities - Go to question 133

Specify cytogenetic abnormalities identified between diagnosis and last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _______________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• –7

• +4

• +8

• +17

• +21

• t(1;19)

• t(2;8)

• t(4;11)

• t(5;14)

• t(8;14)

• t(8;22)

• t(9;22)

• t(10;14)

• t(11;14)

• t(12;21)

• del(6q) / 6q–

• del(9p) / 9p–

• del(12p) / 12p–

• add(14q)

• (11q23) any abnormality

• 9p any abnormality

• 12p any abnormality

• Hyperdiploid (> 50)

• Hypodiploid (< 46)

• iAMP21

• Other abnormality – Go to question 132

3. Specify other abnormality: _________________________

4. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)

• Yes

• No

3. Were tests for molecular markers performed? (e.g. PCR, NGS) (between diagnosis and last evaluation)

• Yes – Go to question 135

• No – Go to question 139

• Unknown – Go to question 139

Specify molecular markers identified between diagnosis and last evaluation

3. BCR / ABL

• Positive

• Negative

• Not done

3. TEL-AML / AML1

• Positive

• Negative

• Not done

3. Other molecular marker

• Positive – Go to question 138

• Negative – Go to question 138

• Not done – Go to question 139

3. Specify other molecular marker: _________________________

Copy and complete questions 137-138 for additional molecular markers

Laboratory studies at last evaluation

3. Were cytogenetics tested (karyotyping or FISH)? (at last evaluation)

• Yes - Go to question 140

• No - Go to question 153

• Unknown - Go to question 153

3. Were cytogenetics tested via FISH?

• Yes - Go to question 141

• No - Go to question 146

3. Results of tests

• Abnormalities identified - Go to question 142

• No abnormalities - Go to question 146

Specify cytogenetic abnormalities identified at last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• –7

• +4

• +8

• +17

• +21

• t(1;19)

• t(2;8)

• t(4;11)

• t(5;14)

• t(8;14)

• t(8;22)

• t(9;22)

• t(10;14)

• t(11;14)

• t(12;21)

• del(6q) / 6q–

• del(9p) / 9p–

• del(12p) / 12p–

• add(14q)

• (11q23) any abnormality

• 9p any abnormality

• 12p any abnormality

• Hyperdiploid (> 50)

• Hypodiploid (< 46)

• iAMP21

• Other abnormality – Go to question 145

3. Specify other abnormality: ____________________

4. Were cytogenetics tested via karyotyping? (at last evaluation)

• Yes - Go to question 147

• No - Go to question 152

3. Results of tests

• Abnormalities identified - Go to question 148

• No evaluable metaphases - Go to question 152

• No abnormalities - Go to question 152

Specify cytogenetic abnormalities identified at last evaluation

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: _______________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

• –7

• +4

• +8

• +17

• +21

• t(1;19)

• t(2;8)

• t(4;11)

• t(5;14)

• t(8;14)

• t(8;22)

• t(9;22)

• t(10;14)

• t(11;14)

• t(12;21)

• del(6q) / 6q–

• del(9p) / 9p–

• del(12p) / 12p–

• add(14q)

• (11q23) any abnormality

• 9p any abnormality

• 12p any abnormality

• Hyperdiploid (> 50)

• Hypodiploid (< 46)

• iAMP21

• Other abnormality – Go to question 151

3. Specify other abnormality: ____________________

4. Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)

• Yes

• No

3. Were tests for molecular markers performed? (e.g. PCR, NGS) (at last evaluation)

• Yes – Go to question 154

• No – Go to question 158

• Unknown – Go to question 158

Specify molecular markers identified at last evaluation

3. BCR / ABL

• Positive

• Negative

• Not done

3. TEL-AML / AML1

• Positive

• Negative

• Not done

3. Other molecular marker

• Positive – Go to question 157

• Negative – Go to question 157

• Not done – Go to question 158

3. Specify other molecular marker: ___________________________

Copy and complete questions 156-157 for additional molecular markers

CNS Leukemia

3. Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen / infusion?

• Yes

• No

• Unknown

Status at transplantation / infusion

3. What was the disease status? (based on hematological test results)

• Primary induction failure – Go to question 163

• 1st complete remission (no previous marrow or extramedullary relapse) (include CRi) – Go to question 160

• 2nd complete remission – Go to question 160

• ≥ 3rd complete remission – Go to question 160

• 1st relapse – Go to question 162

• 2nd relapse – Go to question 162

• ≥ 3rd relapse – Go to question 162

• No treatment – Go to question 163

3. How many cycles of induction therapy were required to achieve 1st complete remission? (include CRi)

• 1

• 2

• ≥ 3

3. Was the recipient in remission by flow cytometry?

• Yes – Go to question 163

• No – Go to question 163

• Unknown – Go to question 163

• Not applicable – Go to question 163

3. Date of most recent relapse: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

3. Specify acute leukemias of ambiguous lineage and other myeloid neoplasm classification

• Blastic plasmacytoid dendritic cell neoplasm (296) – Go to question 166

• Acute undifferentiated leukemia (31) – Go to question 166

• Mixed phenotype acute leukemia (MPAL) with t(9;22)(q34.1;q11.2); BCR-ABL1 (84) – Go to question 166

• Mixed phenotype acute leukemia with t(v; 11q23.3); KMT2A rearranged (85) – Go to question 166

• Mixed phenotype acute leukemia, B/myeloid, NOS (86) – Go to question 166

• Mixed phenotype acute leukemia, T/myeloid, NOS (87) – Go to question 166

• Other acute leukemia of ambiguous lineage or myeloid neoplasm (88) - Go to question 165

3. Specify other acute leukemia of ambiguous lineage or myeloid neoplasm: __________________

Status at transplantation / infusion

3. What was the disease status? (based on hematological test results)

• Primary induction failure

• 1st complete remission (no previous marrow or extramedullary relapse)

• 2nd complete remission

• ≥ 3rd complete remission

• 1st relapse

• 2nd relapse

• ≥3rd relapse

• No treatment

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Chronic Myelogenous Leukemia (CML)

3. Was therapy given prior to this HCT?

• Yes - Go to question 169

• No - Go to question 175

3. Combination chemotherapy

• Yes

• No

3. Hydroxyurea (Droxia, Hydrea)

• Yes

• No

3. Tyrosine kinase inhibitor (e.g.imatinib mesylate, dasatinib, nilotinib)

• Yes

• No

3. Interferon-α (Intron, Roferon) (includes PEG)

• Yes

• No

3. Other therapy

• Yes - Go to question 174

• No - Go to question 175

3. Specify other therapy: ______________________________________

4. What was the disease status?

• Complete hematologic response (CHR) preceded only by chronic phase- Go to question 176

• Complete hematologic response (CHR) preceded by accelerated phase and/or blast phase- Go to question 176

• Chronic phase – Go to question 176

• Accelerated phase - Go to question 177

• Blast phase - Go to question 177

3. Specify level of response

• No cytogenetic response (No CyR)

• Minimal cytogenetic response

• Minor cytogenetic response

• Partial cytogenetic response (PCyR)

• Complete cytogenetic response (CCyR)

• Major molecular remission (MMR)

• Complete molecular remission (CMR)

3. Number

• 1st

• 2nd

• 3rd or higher

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Myelodysplastic Syndrome (MDS)

179. What was the MDS subtype at diagnosis? – If transformed to AML, indicate AML as primary disease; also complete AML Disease Classification questions

• Atypical chronic myeloid leukemia (aCML), BCR-ABL1 (1440) – Go to question 376

• Chronic myelomonocytic leukemia (CMMoL) (54) – Go to question 182

• Juvenile myelomonocytic leukemia (JMML) (36) – Go to question 218

• Myelodysplastic syndrome / myeloproliferative neoplasm, unclassifiable (69) – Go to question 181

• MDS / MPN with ring sideroblasts and thrombocytosis (MDS / MPN–RS–T) (1452) – Go to question 182

• Myelodysplastic syndrome (MDS), unclassifiable (50)– Go to question 180

• Myelodysplastic syndrome with isolated del(5q) (66)– Go to question 182

• Myelodysplastic syndrome with multilineage dysplasia (MDS-MLD) (64) – Go to question 182

• Myelodysplastic syndrome with single lineage dysplasia (MDS-SLD) (51) – Go to question 182

• Refractory cytopenia of childhood (68)– Go to question 182

Myelodysplastic syndrome with excess blasts (MDS-EB)

• MDS with excess blasts-1 (MDS-EB-1) (61) – Go to question 182

• MDS with excess blasts-2 (MDS-EB-2) (62) – Go to question 182

Myelodysplastic syndrome with ring sideroblasts (MDS-RS)

• MDS-RS with single lineage dysplasia (MDS-RS-SLD) (1453) – Go to question 182

• MDS-RS with multilineage dysplasia (MDS-RS-MLD) (1454) – Go to question 182

3. Specify Myelodysplastic syndrome, unclassifiable (MDS-U)

• MDS-U with 1% blood blasts

• MDS-U with single lineage dysplasia and pancytopenia

• MDS-U based on defining cytogenetic abnormality

3. Was documentation submitted to the CIBMTR? (e.g. pathology report used for diagnosis)

• Yes

• No

3. Was the disease MDS therapy related?

• Yes

• No

• Unknown

3. Did the recipient have a predisposing condition?

• Yes – Go to question 184

• No – Go to question 186

• Unknown – Go to question 186

3. Specify condition

• Aplastic anemia – Go to question 186

• DDX41-associated familial MDS – Go to question 186

• Diamond-Blackfan Anemia – Go to question 186

• Fanconi anemia –Go to question 186

• GATA2 deficiency (including Emberger syndrome, MonoMac syndrome, DCML deficiency) – Go to question 186

• Li-Fraumeni Syndrome – Go to question 186

• Paroxysmal nocturnal hemoglobinuria – Go to question 186

• RUNX1 deficiency (previously “familial platelet disorder with propensity to myeloid malignancies”) – Go to question 186

• SAMD9- or SAMD9L-associated familial MDS – Go to question 186

• Shwachman-Diamond Syndrome – Go to question 186

• Telomere biology disorder (including dyskeratosis congenita) – Go to question 186

• Other condition – Go to question 185

3. Specify other condition: _______________________

Laboratory studies at diagnosis of MDS

3. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. WBC

• Known – Go to question 188

• Unknown – Go to question 189

3. ___ ___ ___ ___ ___ ___ ● ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Neutrophils

• Known – Go to question 190

• Unknown – Go to question 191

3. ___ ___%

4. Blasts in blood

• Known – Go to question 192

• Unknown– Go to question 193

3. ___ ___ ___ %

3. Hemoglobin

• Known – Go to question 194

• Unknown – Go to question 196

3. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

3. Were RBCs transfused ≤ 30 days before date of test?

• Yes

• No

3. Platelets

• Known – Go to question 197

• Unknown – Go to question 199

3. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Were platelets transfused ≤ 7 days before date of test?

• Yes

• No

3. Blasts in bone marrow

• Known – Go to question 200

• Unknown – Go to question 201

3. ___ ___ ___ %

4. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 202

• No – Go to question 218

• Unknown – Go to question 218

3. Were cytogenetics tested via FISH?

• Yes- Go to question 203

• No- Go to question 210

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 205

• No abnormalities – Go to question 209

Specify cytogenetic abnormalities identified via FISH at diagnosis

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –13

• –20

• –Y

Trisomy

• +8

• +19

Translocation

• t(1;3)

• t(2;11)

• t(3;3)

• t(3;21)

• t(6;9)

• t(11;16)

Deletion

• del(3q) / 3q-

• del(5q) / 5q-

• del(7q) / 7q-

• del(9q) / 9q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• inv(3)

Other

• i17q

• Other abnormality – Go to question 208

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. FISH report)

• Yes

• No

3. Were cytogenetics tested via karyotyping?

• Yes- Go to question 211

• No- Go to question 218

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 213

• No evaluable metaphases- Go to question 217

• No abnormalities – Go to question 217

Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –13

• –20

• –Y

Trisomy

• +8

• +19

Translocation

• t(1;3)

• t(2;11)

• t(3;3)

• t(3;21)

• t(6;9)

• t(11;16)

Deletion

• del(3q) / 3q-

• del(5q) / 5q-

• del(7q) / 7q-

• del(9q) / 9q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• inv(3)

Other

• i17q

• Other abnormality – Go to question 216

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)

• Yes

• No

3. Did the recipient progress or transform to a different MDS subtype or AML between diagnosis and the start of the preparative regimen / infusion?

• Yes – Go to question 219

• No – Go to question 223

3. Specify the MDS subtype or AML after transformation

• Chronic myelomonocytic leukemia (CMMoL) (54) – Go to question 221

• Myelodysplastic syndrome / myeloproliferative neoplasm, unclassifiable (69) – Go to question 221

• MDS / MPN with ring sideroblasts and thrombocytosis (MDS / MPN–RS–T) (1452) – Go to question 221

• Myelodysplastic syndrome (MDS), unclassifiable (50) – Go to question 220

• Myelodysplastic syndrome with isolated del(5q) (66) – Go to question 221

• Myelodysplastic syndrome with multilineage dysplasia (MDS-MLD) (64) – Go to question 221

• Myelodysplastic syndrome with single lineage dysplasia (MDS-SLD)) (51) – Go to question 221

• Refractory cytopenia of childhood (68) – Go to question 221

• Transformed to AML (70) – Go to question 222

Myelodysplastic syndrome with excess blasts (MDS-EB)

• MDS with excess blasts-1 (MDS-EB-1) (61) – Go to question 221

• MDS with excess blasts-2 (MDS-EB-2) (62) – Go to question 221

Myelodysplastic syndrome with ring sideroblasts

• MDS-RS with single lineage dysplasia (MDS-RS-SLD) (1453) – Go to question 221

• MDS-RS with multilineage dysplasia (MDS-RS-MLD) (1454) – Go to question 221

3. Specify Myelodysplastic syndrome, unclassifiable (MDS-U)

• MDS-U with 1% blood blasts– Go to question 221

• MDS-U with single lineage dysplasia and pancytopenia– Go to question 221

• MDS-U based on defining cytogenetic abnormality– Go to question 221

3. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 223

4. Date of MDS diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line

Laboratory studies at last evaluation prior to the start of the preparative regimen / infusion

3. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. WBC

• Known – Go to question 225

• Unknown – Go to question 226

3. ___ ___ ___ ___ ___ ___ ● ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Neutrophils

• Known – Go to question 227

• Unknown – Go to question 228

3. ___ ___%

4. Blasts in blood

• Known – Go to question 229

• Unknown – Go to question 230

3. ___ ___ ___ %

4. Hemoglobin

• Known – Go to question 231

• Unknown – Go to question 233

3. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

3. Were RBCs transfused ≤ 30 days before date of test?

• Yes

• No

3. Platelets

• Known – Go to question 234

• Unknown – Go to question 236

3. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Were platelets transfused ≤ 7 days before date of test?

• Yes

• No

3. Blasts in bone marrow

• Known – Go to question 237

• Unknown – Go to question 238

3. ___ ___ ___ %

4. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 239

• No – Go to question 255

• Unknown – Go to question 255

3. Were cytogenetics tested via FISH?

• Yes- Go to question 240

• No- Go to question 247

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 242

• No abnormalities – Go to question 246

Specify cytogenetic abnormalities identified via FISH at last evaluation prior to the start of the preparative regimen / infusion

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –13

• –20

• –Y

Trisomy

• +8

• +19

Translocation

• t(1;3)

• t(2;11)

• t(3;3)

• t(3;21)

• t(6;9)

• t(11;16)

Deletion

• del(3q) / 3q-

• del(5q) / 5q-

• del(7q) / 7q-

• del(9q) / 9q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• inv(3)

Other

• i17q

• Other abnormality – Go to question 245

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. FISH report)

• Yes

• No

3. Were cytogenetics tested via karyotyping?

• Yes- Go to question 248

• No- Go to question 255

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 250

• No evaluable metaphases- Go to question 254

• No abnormalities – Go to question 254

Specify cytogenetic abnormalities identified via conventional cytogenetics at last evaluation prior to the start of the preparative regimen / infusion

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• 13

• –20

• –Y

Trisomy

• +8

• +19

Translocation

• t(1;3)

• t(2;11)

• t(3;3)

• t(3;21)

• t(6;9)

• t(11;16)

Deletion

• del(3q) / 3q-

• del(5q) / 5q-

• del(7q) / 7q-

• del(9q) / 9q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• inv(3)

Other

• i17q

• Other abnormality – Go to question 253

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)

• Yes

• No

Status at transplantation / infusion

3. What was the disease status?

• Complete remission (CR) –- Go to question 258

• Hematologic improvement (HI) – Go to question 256

• No response (NR) / stable disease (SD) – Go to question 258

• Progression from hematologic improvement (Prog from HI) - Go to question 258

• Relapse from complete remission (Rel from CR) - Go to question 258

• Not assessed - Go to signature line

3. Specify the cell line examined to determine HI status (check all that apply)

• HI-E –- Go to question 257

• HI-P – Go to question 258

• HI-N – Go to question 258

3. Specify transfusion dependence

• Non transfused (NTD)-– Go to question 258

• Low transfusion burden (LTB)- Go to question 258

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___- Go to signature line

YYYY MM DD

Myeloproliferative Neoplasms (MPN)

3. What was the MPN subtype at diagnosis? – If transformed to AML, indicate AML as primary disease; also complete AML Disease Classification questions

• Chronic neutrophilic leukemia (165) –Go to Question 262

• Chronic eosinophilic leukemia, not otherwise specified (NOS) (166) – Go to Question 262

• Essential thrombocythemia (58) – Go to Question 262

• Myeloproliferative neoplasm (MPN), unclassifiable (60) – Go to Question 260

• Myeloid / lymphoid neoplasms with PDGFRA rearrangement (1461) – Go to Question 262

• Myeloid / lymphoid neoplasms with PDGFRB rearrangement (1462) – Go to Question 262

• Myeloid / lymphoid neoplasms with FGFR1 rearrangement (1463) – Go to Question 262

• Myeloid / lymphoid neoplasms with PCM1-JAK2 (1464) – Go to Question 262

• Polycythemia vera (PCV) (57) – Go to Question 262

• Primary myelofibrosis (PMF) (167)- Go to Question 262

Mastocytosis

• Cutaneous mastocytosis (CM) (1465) – Go to Question 262

• Systemic mastocytosis (1470) - Go to Question Error! Reference source not found.

• Mast cell sarcoma (MCS) (1466) – Go to Question 262

3. Specify systemic mastocytosis

• Indolent systemic mastocytosis (ISM) – Go to Question 262

• Smoldering systemic mastocytosis (SSM) – Go to question 262

• Systemic mastocytosis with an associated hematological neoplasm (SM-AHN) – Go to question 262

• Aggressive systemic mastocytosis (ASM) – Go to question 262

• Mast cell leukemia (MCL) – Go to question 262

3. Was documentation submitted to the CIBMTR? (e.g. pathology report used for diagnosis)

• Yes

• No

Assessment at diagnosis

3. Did the recipient have constitutional symptoms in six months before diagnosis? (symptoms are >10% weight loss in 6 months, night sweats, or unexplained fever higher than 37.5 °C)

• Yes

• No

• Unknown

Laboratory studies at diagnosis of MPN

3. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. WBC

• Known – Go to question 265

• Unknown – Go to question 266

3. ___ ___ ___ ___ ___ ___ ● ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Neutrophils

• Known – Go to question 267

• Unknown – Go to question 268

3. ___ ___%

4. Blasts in blood

• Known – Go to question 269

• Unknown– Go to question 270

3. ___ ___ ___ %

4. Hemoglobin

• Known – Go to question 271

• Unknown – Go to question 273

3. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

3. Were RBCs transfused ≤ 30 days before date of test?

• Yes

• No

3. Platelets

• Known – Go to question 274

• Unknown – Go to question 276

3. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Were platelets transfused ≤ 7 days before date of test?

• Yes

• No

3. Blasts in bone marrow

• Known – Go to question 277

• Unknown – Go to question 278

3. ___ ___ ___ %

4. Were tests for driver mutations performed?

• Yes – Go to question 279

• No – Go to question 289

• Unknown - Go to question 289

3. JAK2

• Positive– Go to question 280

• Negative– Go to question 282

• Not done– Go to question 282

3. JAK2 V617F

• Positive

• Negative

• Not done

3. JAK2 Exon 12

• Positive

• Negative

• Not done

3. CALR

• Positive – Go to question 283

• Negative– Go to question 286

• Not done– Go to question 286

3. CALR type 1

• Positive

• Negative

• Not done

3. CALR type 2

• Positive

• Negative

• Not done

3. Not defined

• Positive

• Negative

• Not done

3. MPL

• Positive

• Negative

• Not done

3. CSF3R

• Positive

• Negative

• Not done

3. Was documentation submitted to the CIBMTR?

• Yes

• No

3. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 290

• No – Go to question 306

• Unknown – Go to question 306

3. Were cytogenetics tested via FISH?

• Yes- Go to question 291

• No- Go to question 298

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 293

• No abnormalities – Go to question 297

Specify cytogenetic abnormalities identified via FISH at diagnosis:

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(11q23;any)

• t(12p11.2;any)

• t(6;9)

Deletion

• del(5q) / 5q-

• del(7q) / 7q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• dup(1)

• inv(3)

Other

• i17q

• Other abnormality – Go to question 296

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. FISH report)

• Yes

• No

3. Were cytogenetics tested via karyotyping?

• Yes- Go to question 299

• No- Go to question 306

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 301

• No evaluable metaphases- Go to question 305

• No abnormalities – Go to question 305

Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(11q23;any)

• t(12p11.2;any)

• t(6;9)

Deletion

• del(5q) / 5q-

• del(7q) / 7q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• dup(1)

• inv(3)

Other

• i17q

• Other abnormality – Go to question 304

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)

• Yes

• No

3. Did the recipient progress or transform to a different MPN subtype or AML between diagnosis and the start of the preparative regimen / infusion?

• Yes – Go to question 307

• No – Go to question 310

3. Specify the MPN subtype or AML after transformation

• Post-essential thrombocythemic myelofibrosis (1467) – Go to question 308

• Post-polycythemic myelofibrosis (1468) – Go to question 308

• Transformed to AML (70) – Go to question 309

3. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 310

4. Date of MPN diagnosis: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line

YYYY MM DD

Assessment at last evaluation prior to the start of the preparative regimen/ infusion

3. Specify transfusion dependence at last evaluation prior to the start of the preparative regimen/ infusion

• Non-transfused (NTD) –(0 RBCs in 16 weeks)

• Low-transfusion burden (LTB) -(3-7 RBCs in 16 weeks in at least 2 transfusion episodes; maximum of 3 in 8 weeks)

• High-transfusion burden (HTB) - (≥ 8 RBCs in 16weeks; ≥ 4 in 8 weeks)

3. Did the recipient have constitutional symptoms in six months before last evaluation prior to the start of the preparative regimen / infusion? (symptoms are >10% weight loss in 6 months, night sweats, or unexplained fever higher than 37.5 °C)

• Yes

• No

• Unknown

3. Did the recipient have splenomegaly at last evaluation prior to the start of the preparative regimen/ infusion?

• Yes – Go to question 313

• No – Go to question 316

• Unknown- Go to question 316

• Not applicable (splenectomy) – Go to question 316

3. Specify the method used to measure spleen size

• Physical assessment- Go to question 314

• Ultrasound- Go to question 315

• CT/ MRI- Go to question 315

3. Specify the spleen size: ___ ___ centimeters below left costal margin – Go to question 317

4. Specify the spleen size:___ ___ centimeters

5. Did the recipient have hepatomegaly at last evaluation prior to the start of the preparative regimen/infusion?

• Yes – Go to question 317

• No – Go to question 320

• Unknown – Go to question 320

3. Specify the method used to measure liver size

• Physical assessment- Go to question 318

• Ultrasound- Go to question 319

• CT/ MRI- Go to question 319

3. Specify the liver size: ___ ___ centimeters below right costal margin – Go to question 321

4. Specify the liver size: ___ ___ centimeters

Laboratory studies at last evaluation prior to the start of the preparative regimen / infusion

3. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. WBC

• Known – Go to question 322

• Unknown – Go to question 323

3. ___ ___ ___ ___ ___ ___ ● ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Neutrophils

• Known – Go to question 324

• Unknown – Go to question 325

3. ___ ___%

4. Blasts in blood

• Known – Go to question 326

• Unknown– Go to question 327

3. ___ ___ ___ %

4. Hemoglobin

• Known – Go to question 328

• Unknown – Go to question 330

3. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

3. Were RBCs transfused ≤ 30 days before date of test?

• Yes

• No

3. Platelets

• Known – Go to question 331

• Unknown – Go to question 333

3. ___ ___ ___ ___ ___ ___ ___  x 10⁹/L (x 10³/mm³)

 x 10⁶/L

3. Were platelets transfused ≤ 7 days before date of test?

• Yes

• No

3. Blasts in bone marrow

• Known – Go to question 334

• Unknown – Go to question 335

3. ___ ___ ___ %

4. Were tests for driver mutations performed?

• Yes – Go to question 336

• No – Go to question 346

• Unknown - Go to question 346

3. JAK2

• Positive– Go to question 337

• Negative– Go to question 339

• Not done– Go to question 339

3. JAK2 V617F

• Positive

• Negative

• Not Done

3. JAK2 Exon 12

• Positive

• Negative

• Not done

3. CALR

• Positive – Go to question 340

• Negative– Go to question 343

• Not done– Go to question 343

3. CALR type 1

• Positive

• Negative

• Not done

3. CALR type 2

• Positive

• Negative

• Not done

3. Not defined

• Positive

• Negative

• Not done

3. MPL

• Positive

• Negative

• Not done

3. CSF3R

• Positive

• Negative

• Not done

3. Was documentation submitted to the CIBMTR?

• Yes

• No

3. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 347

• No – Go to question 363

• Unknown – Go to question 363

3. Were cytogenetics tested via FISH?

• Yes- Go to question 348

• No- Go to question 355

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 350

• No abnormalities – Go to question 354

Specify cytogenetic abnormalities identified via FISH at last evaluation prior to the start of the preparative regimen / infusion

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(11q23;any)

• t(12p11.2;any)

• t(6;9)

Deletion

• del(5q) / 5q-

• del(7q) / 7q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• dup(1)

• inv(3)

Other

• i17q

• Other abnormality – Go to question 353

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. FISH report)

• Yes

• No

3. Were cytogenetics tested via karyotyping?

• Yes- Go to question 356

• No- Go to question 363

3. Sample source

• Blood

• Bone marrow

3. Results of tests

• Abnormalities identified – Go to question 358

• No evaluable metaphases- Go to question 362

• No abnormalities – Go to question 362

Specify cytogenetic abnormalities identified via conventional cytogenetics at last evaluation prior to the start of the preparative regimen / infusion

3. International System for Human Cytogenetic Nomenclature (ISCN) compatible string: __________________________

4. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

3. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(11q23;any)

• t(12p11.2;any)

• t(6;9)

Deletion

• del(5q) / 5q-

• del(7q) / 7q-

• del(11q) / 11q-

• del(12p) / 12p-

• del(13q) / 13q-

• del(20q) / 20q-

Inversion

• dup(1)

• inv(3)

Other

• i17q

• Other abnormality – Go to question 361

3. Specify other abnormality:__________________________

4. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)

• Yes

• No

Status at transplantation / infusion

3. What was the disease status?

• Complete clinical remission (CR) - Go to question 367

• Partial clinical remission (PR) –- Go to question 367

• Clinical improvement (CI) - Go to question 364

• Stable disease (SD)- Go to question 367

• Progressive disease - Go to question 367

• Relapse- Go to question 367

• Not assessed - Go to question 368

3. Was an anemia response achieved?

• Yes

• No

3. Was a spleen response achieved?

• Yes

• No

3. Was a symptom response achieved?

• Yes

• No

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___- Go to question 368

YYYY MM DD

3. Specify the cytogenetic response

• Complete response (CR): Eradication of pre-existing abnormality – Go to question 369

• Partial response (PR): ≥ 50% reduction in abnormal metaphases – Go to question 369

• Re-emergence of pre-existing cytogenetic abnormality – Go to question 369

• Not assessed – Go to question 370

• Not applicable – Go to question 370

• None of the above: Does not meet the CR or PR criteria – Go to question 369

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. Specify the molecular response

• Complete response (CR): Eradication of pre-existing abnormality – Go to question 371

• Partial response (PR): ≥50% decrease in allele burden – Go to question 371

• Re-emergence of a pre-existing molecular abnormality – Go to question 371

• Not assessed – Go to First Name

• Not applicable – Go to First Name

• None of the above: Does not meet the CR or PR criteria – Go to 371

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Other Leukemia (OL)

3. Specify the other leukemia classification

• Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 374

• Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 374

• Hairy cell leukemia (35) - Go to question 377

• Hairy cell leukemia variant (75) - Go to question 377

• Monoclonal B-cell lymphocytosis (76) – Go to signature line

• Prolymphocytic leukemia (PLL), NOS (37) - Go to question 374

• PLL, B-cell (73) - Go to question 374

• PLL, T-cell (74) - Go to question 374

• Other leukemia, NOS (30) - Go to question 376

• Other leukemia (39) - Go to question 373

3. Specify other leukemia: _________________________________– Go to question 376

4. Was any 17p abnormality detected?

• Yes – If disease classification is CLL, go to question 375. If PLL, go to question 377

• No

3. Did a histologic transformation to diffuse large B-cell lymphoma (Richter syndrome) occur at any time after CLL diagnosis?

• Yes – Go to question 379– Also complete NHL Disease Classification questions

• No – Go to question 377

Status at transplantation / infusion:

3. What was the disease status? (Atypical CML)

• Primary induction failure – Go to question 378

• 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 378

• 2nd complete remission – Go to question 378

• ≥ 3rd complete remission – Go to question 378

• 1st relapse – Go to question 378

• 2nd relapse – Go to question 378

• ≥ 3rd relapse – Go to question 378

• No treatment – Go to signature line

3. What was the disease status? (CLL, PLL, Hairy cell leukemia)

• Complete remission (CR) – Go to question 378

• Partial remission (PR) – Go to question 378

• Stable disease (SD) – Go to question 378

• Progressive disease (Prog) – Go to question 378

• Untreated - Go to question 378

• Not assessed - Go to signature line

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Hodgkin and Non-Hodgkin Lymphoma

3. Specify the lymphoma histology (at infusion)

Hodgkin Lymphoma Codes

• Hodgkin lymphoma, not otherwise specified (150)

• Lymphocyte depleted (154)

• Lymphocyte-rich (151)

• Mixed cellularity (153)

• Nodular lymphocyte predominant Hodgkin lymphoma (155)

• Nodular sclerosis (152)

Non-Hodgkin Lymphoma Codes

B-cell Neoplasms

• ALK+ large B-cell lymphoma (1833)

• B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (149)

• Burkitt lymphoma (111)

• Burkitt-like lymphoma with 11q aberration (1834)

• Diffuse, large B-cell lymphoma- Activated B-cell type (non-GCB) (1821) - Go to question 381

• Diffuse, large B-cell lymphoma- Germinal center B-cell type (1820) - Go to question 381

• Diffuse large B-cell Lymphoma (cell of origin unknown) (107)

• DLBCL associated with chronic inflammation (1825)

• Duodenal-type follicular lymphoma (1815)

• EBV+ DLBCL, NOS (1823)

• EBV+ mucocutaneous ulcer (1824)

• Extranodal marginal zone B-cell lymphoma of mucosal associated lymphoid tissue type (MALT) (122)

• Follicular, mixed, small cleaved and large cell (Grade II follicle center lymphoma) (103)

• Follicular, predominantly large cell (Grade IIIA follicle center lymphoma) (162)

• Follicular, predominantly large cell (Grade IIIB follicle center lymphoma) (163)

• Follicular, predominantly large cell (Grade IIIA vs IIIB not specified) (1814)

• Follicular, predominantly small cleaved cell (Grade I follicle center lymphoma) (102)

• Follicular (grade unknown) (164)

• HHV8+ DLBCL, NOS (1826)

• High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (1831)

• High-grade B-cell lymphoma, NOS (1830)

• Intravascular large B-cell lymphoma (136)

• Large B-cell lymphoma with IRF4 rearrangement (1832)

• Lymphomatoid granulomatosis (1835)

• Mantle cell lymphoma (115)

• Nodal marginal zone B-cell lymphoma (± monocytoid B-cells) (123)

• Pediatric nodal marginal zone lymphoma (1813)

• Pediatric-type follicular lymphoma (1816)

• Plasmablastic lymphoma (1836)

• Primary cutaneous DLBCL, leg type (1822)

• Primary cutaneous follicle center lymphoma (1817)

• Primary diffuse, large B-cell lymphoma of the CNS (118)

• Primary effusion lymphoma (138)

• Primary mediastinal (thymic) large B-cell lymphoma (125)

• Splenic B-cell lymphoma/leukemia, unclassifiable (1811)

• Splenic diffuse red pulp small B-cell lymphoma (1812)

• Splenic marginal zone B-cell lymphoma (124)

• T-cell / histiocytic rich large B-cell lymphoma (120)

• Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173)

• Other B-cell lymphoma (129) – Go to question 380

T-cell and NK-cell Neoplasms

• Adult T-cell lymphoma / leukemia (HTLV1 associated) (134)

• Aggressive NK-cell leukemia (27)

• Anaplastic large-cell lymphoma (ALCL), ALK positive (143)

• Anaplastic large-cell lymphoma (ALCL), ALK negative (144)

• Angioimmunoblastic T-cell lymphoma (131)

• Breast implant–associated anaplastic large-cell lymphoma (1861)

• Chronic lymphoproliferative disorder of NK cells (1856)

• Enteropathy-type T-cell lymphoma (133)

• Extranodal NK / T-cell lymphoma, nasal type (137)

• Follicular T-cell lymphoma (1859)

• Hepatosplenic T-cell lymphoma (145)

• Indolent T-cell lymphoproliferative disorder of the GI tract (1858)

• Monomorphic epitheliotropic intestinal T-cell lymphoma (1857)

• Mycosis fungoides (141)

• Nodal peripheral T-cell lymphoma with TFH phenotype (1860)

• Peripheral T-cell lymphoma (PTCL), NOS (130)

• Primary cutaneous acral CD8+ T-cell lymphoma (1853)

• Primary cutaneous CD4+ small/medium T-cell lymphoproliferative disorder (1854)

• Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma (1852)

• Primary cutaneous CD30+ T-cell lymphoproliferative disorders [Primary cutaneous anaplastic large-cell lymphoma (C-ALCL), lymphoid papulosis] (147)

• Primary cutaneous γδ T-cell lymphoma (1851)

• Sezary syndrome (142)

• Subcutaneous panniculitis-like T-cell lymphoma (146)

• Systemic EBV+ T-cell lymphoma of childhood (1855)

• T-cell large granular lymphocytic leukemia (126)

• Other T-cell / NK-cell lymphoma (139) – Go to question 380

Posttransplant lymphoproliferative disorders (PTLD)

• Classical Hodgkin lymphoma PTLD (1876)

• Florid follicular hyperplasia PTLD (1873)

• Infectious mononucleosis PTLD (1872)

• Monomorphic PTLD (B- and T-/NK-cell types) (1875)

• Plasmacytic hyperplasia PTLD (1871)

• Polymorphic PTLD (1874)

3. Specify other lymphoma histology: ______________________– Go to question 382

4. Assignment of DLBCL (germinal center B-cell type vs. activated B-cell type) subtype was based on:

• Immunohistochemistry (e.g. Han’s algorithm)

• Gene expression profile

• Unknown method

3. Is the lymphoma histology reported at transplant a transformation from CLL?

• Yes – Go to question 383

• No - Go to question 384

3. Was any 17p abnormality detected?

• Yes– Go to question 388

• No– Go to question 388

3. Is the lymphoma histology reported at transplant a transformation from a different lymphoma histology? (Not CLL)

• Yes – Go to question 385

• No – Go to question 388

3. Specify the original lymphoma histology (prior to transformation) _________________

4. Specify other lymphoma histology:________________

5. Date of original lymphoma diagnosis:___ ___ ___ ___ - ___ ___ - ___ ___ (report the date of diagnosis of original lymphoma subtype)

6. Was a PET (or PET/CT) scan performed? (at last evaluation prior to the start of the preparative regimen / infusion)

• Yes – Go to question 389

• No – Go to question 394

3. Was the PET (or PET/CT) scan positive for lymphoma involvement at any disease site?

• Yes

• No

3. Date of PET scan

• Known– Go to question 391

• Unknown – Go to question 392

3. Date of PET (or PET/CT) scan: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

3. Deauville (five-point) score of the PET (or PET/CT) scan

• Known – Go to question 393

• Unknown – Go to question 394

3. Scale

• 1- no uptake or no residual uptake

• 2- slight uptake, but below blood pool (mediastinum)

• 3- uptake above mediastinal, but below or equal to uptake in the liver

• 4- uptake slightly to moderately higher than liver

• 5- markedly increased uptake or any new lesion

Status at transplantation / infusion:

3. What was the disease status?

• Disease untreated– Go to signature line

• PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or progressive disease on treatment. – Go to question 395

• PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial remission on treatment. – Go to question 395

• PIF unk - Primary induction failure – sensitivity unknown– Go to question 395

• CR1 - 1^st complete remission: no bone marrow or extramedullary relapse prior to transplant– Go to question 395

• CR2 - 2^nd complete remission– Go to question 395

• CR3+ - 3^rd or subsequent complete remission– Go to question 395

• REL1 unt - 1^st relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 395

• REL1 res - 1^st relapse – resistant: stable or progressive disease with treatment– Go to question 395

• REL1 sen - 1^st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2) – Go to question 395

• REL1 unk - 1^st relapse – sensitivity unknown– Go to question 395

• REL2 unt - 2^nd relapse – untreated: includes either bone marrow or extramedullary relapse– Go to question 395

• REL2 res - 2^nd relapse – resistant: stable or progressive disease with treatment– Go to question 395

• REL2 sen - 2^nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 395

• REL2 unk - 2^nd relapse – sensitivity unknown– Go to question 395

• REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 395

• REL3+ res - 3^rd or subsequent relapse – resistant: stable or progressive disease with treatment– Go to question 395

• REL3+ sen - 3^rd or subsequent relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 395

• REL3+ unk - 3^rd relapse or greater – sensitivity unknown– Go to question 395

3. Total number of lines of therapy received (between diagnosis and HCT / infusion)

• 1 line

• 2 lines

• 3+ lines

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

Multiple Myeloma / Plasma Cell Disorder (PCD)

3. Specify the multiple myeloma/plasma cell disorder (PCD) classification

• Multiple myeloma (178) – Go to question 399

• Multiple myeloma-light chain only (186) - Go to question 399

• Multiple myeloma-non-secretory (187) - Go to question 405

• Plasma cell leukemia (172) - Go to question 407

• Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 404

• Smoldering myeloma (180) – Go to question 407

• Amyloidosis (174) - Go to question 400

• Osteosclerotic myeloma / POEMS syndrome (176) - Go to question 407

• Monoclonal gammopathy of renal significance (MGRS) (1611) – Go to question 401

• Other plasma cell disorder (179) - Go to question 398

3. Specify other plasma cell disorder: _________________________ - Go to question 407

4. Specify heavy and/or light chain type (check all that apply)

• IgG kappa – Go to question 405

• IgA kappa – Go to question 405

• IgM kappa – Go to question 405

• IgD kappa – Go to question 405

• IgE kappa – Go to question 405

• IgG lambda – Go to question 405

• IgA lambda – Go to question 405

• IgM lambda – Go to question 405

• IgD lambda – Go to question 405

• IgE lambda – Go to question 405

• IgG (heavy chain only) – Go to question 405

• IgA (heavy chain only) – Go to question 405

• IgM (heavy chain only) – Go to question 405

• IgD (heavy chain only) – Go to question 405

• IgE (heavy chain only) – Go to question 405

• Kappa (light chain only) – Go to question 405

• Lambda (light chain only) – Go to question 405

3. Specify Amyloidosis classification

• AL amyloidosis – Go to question 407

• AH amyloidosis – Go to question 407

• AHL amyloidosis – Go to question 407

3. Select monoclonal gammopathy of renal significance (MGRS) classification

• Light chain fanconi syndrome – Go to question 403

• Proximal tubulopathy without crystals – Go to question 403

• Crystal-storing histiocytosis – Go to question 403

• Non-amyloid fibrillary glomerulonephritis – Go to question 403

• Immunotactoid glomerulopathy (ITGN)/ Glomerulonephritis with organized monoclonal microtubular immunoglobulin deposits (GOMMID) – Go to question 403

• Type 1 cryoglobulinemic glomerulonephritis – Go to question 403

• Monoclonal immunoglobulin deposition disease (MIDD) – Go to question 402

• Proliferative glomerulonephritis with monoclonal immunoglobulin G deposits (PGNMID) – Go to question 403

• C3 glomerulopathy with monoclonal gammopathy – Go to question 403

• Unknown – Go to question 403

3. Select monoclonal immunoglobulin deposition disease (MIDD) subtype

• Light chain deposition disease (LCDD)

• Light and heavy chain deposition disease (LHCDD)

• Heavy chain deposition disease (HCDD)

3. Was documentation submitted to the CIBMTR? (e.g. pathology report)

• Yes – Go to question 407

• No – Go to question 407

3. Solitary plasmacytoma was

• Extramedullary – Go to question 407

• Bone derived – Go to question 407

3. What was the Durie-Salmon staging? (at diagnosis)

• Stage I (All of the following: Hgb > 10g/dL; serum calcium normal or <10.5 mg/dL; bone x-ray normal bone structure (scale 0), or solitary bone plasmacytoma only; low M-component production rates IgG < 5g/dL, IgA < 3g/dL; urine light chain M-component on electrophoresis <4g/24h) – Go to question 406

• Stage II (Fitting neither Stage I or Stage III) – Go to question 406

• Stage III (One of more of the following: Hgb < 8.5 g/dL; serum calcium > 12 mg/dL; advanced lytic bone lesions (scale 3); high M-component production rates IgG >7g/dL, IgA > 5g/dL; Bence Jones protein >12g/24h) – Go to question 406

• Unknown – Go to question 407

3. What was the Durie-Salmon sub classification? (at diagnosis)

• A - relatively normal renal function (serum creatinine < 2.0 mg/dL)

• B - abnormal renal function (serum creatinine ≥ 2.0 mg/dL)

3. Did the recipient have a preceding or concurrent plasma cell disorder?

• Yes – Go to question 408

• No – Go to question 411

3. Specify preceding / concurrent disorder

• Multiple myeloma– Go to question 410

• Multiple myeloma-light chain only – Go to question 410

• Multiple myeloma-non-secretory – Go to question 410

• Plasma cell leukemia – Go to question 410

• Solitary plasmacytoma (no evidence of myeloma) – Go to question 410

• Smoldering myeloma – Go to question 410

• Amyloidosis – Go to question 410

• Osteosclerotic myeloma / POEMS syndrome – Go to question 410

• Monoclonal gammopathy of unknown significance (MGUS) – Go to question 410

• Monoclonal gammopathy of renal significance (MGRS) – Go to question 410

• Other plasma cell disorder (PCD) – Go to question 409

3. Specify other preceding/concurrent disorder: ___________________________________

4. Date of diagnosis of preceding / concurrent disorder: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Copy questions 408- 410 to report more than one concurrent or preceding disorder.

3. Serum β2-microglobulin

• Known – Go to question 412

• Unknown – Go to question 413

3. Serum β2-microglobulin: ___ ___ ___ ● ___ ___ ___  μg/dL

 mg/L

 nmol/L

3. Serum albumin

• Known – Go to question 414

• Unknown – Go to question 415

3. Serum albumin: ___ ___ ● ___  g/dL

 g/L

I.S.S. at diagnosis

3. Stage

• Known – Go to question 416

• Unknown – Go to question 417

3. Stage

• 1 (Serum β2-microglobulin < 3.5 mg/L, Serum albumin ≥ 3.5 g/dL)

• 2 (Not fitting stage 1 or 3)

• 3 (Serum β2-microglobulin ≥ 5.5 mg/L; Serum albumin —)

R - I.S.S. at diagnosis

3. Stage

• Known – Go to question 418

• Unknown – Go to question 419

3. Stage

• 1 (ISS stage I and no high-risk cytogenetic abnormalities by FISH and normal LDH levels)

• 2 (Not R-ISS stage I or III)

• 3 (ISS stage III and either high-risk cytogenetic abnormalities by FISH or high LDH levels)

3. Plasma cells in blood by flow cytometry

• Known – Go to question 420

• Unknown – Go to question 421

3. ___ ___• ___ ___ %

4. Plasma cells in blood by morphologic assessment

• Known – Go to question 422

• Unknown – Go to question 424

3. ___ ___%

4. ___ ___ ___ ___ ___ • ___ ___ □ x 10⁹/L (x 10³/mm³)

□ x 10⁶/L

3. LDH

• Known – Go to question 425

• Unknown – Go to question 427

3. ___ ___ ___ ___ ___ ● ___ ___  U/L

 μkat/L

3. Upper limit of normal for LDH: ___ ___ ___ ___ ___ • ___ ___

Labs at diagnosis

3. Were cytogenetics tested (karyotyping or FISH)? (at diagnosis)

• Yes – Go to question 428

• No – Go to question 440

• Unknown – Go to question 440

3. Were cytogenetics tested via FISH?

• Yes – Go to question 429

• No – Go to question 434

3. Results of tests

• Abnormalities identified – Go to question 430

• No abnormalities – Go to question 433

Specify cytogenetic abnormalities identified via FISH at diagnosis:

3.  International System for Human Cytogenetic Nomenclature (ISCN) compatible string:____________________

4. Specify abnormalities (check all that apply)

Trisomy

• +3

• +5

• +7

• +9

• +11

• +15

• +19

Translocation

• t(4;14)

• t(6;14)

• t(11;14)

• t(14;16)

• t(14;20)

Deletion

• del (13)/13q-

• del (17)/17p-

Monosomy

• - 13

• - 17

Other

• Hyperdiploid (>50)

• Hypodiploid (<46)

• MYC rearrangement

• Any abnormality at 1q

• Any abnormality at 1p

• Other abnormality– Go to question 432

3. Specify other abnormality:_______________________________

4. Was documentation submitted to the CIBMTR? (e.g. FISH report)

• Yes

• No

3. Were cytogenetics tested via karyotyping?

• Yes – Go to question 435

• No – Go to question 440

3. Results of tests

• Abnormalities identified – Go to question 436

• No evaluable metaphases – Go to question 439

• No abnormalities – Go to question 439

Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis

3.  International System for Human Cytogenetic Nomenclature (ISCN) compatible string:____________________

4. Specify abnormalities (check all that apply)

Trisomy

• +3

• +5

• +7

• +9

• +11

• +15

• +19

Translocation

• t(4;14)

• t(6;14)

• t(11;14)

• t(14;16)

• t(14;20)

Deletion

• del (13)/13q-

• del (17)/17p-

Monosomy

• - 13

• - 17

Other

• Hyperdiploid (>50)

• Hypodiploid (<46)

• MYC rearrangement

• Any abnormality at 1q

• Any abnormality at 1p

• Other abnormality– Go to question 438

3. Specify other abnormality:________________________________

4. Was documentation submitted to the CIBMTR? (e.g. karyotyping report)

• Yes

• No

Status at transplantation / infusion

3. What is the hematologic disease status?

• Stringent complete response (sCR)

• Complete response (CR)

• Very good partial response (VGPR )

• Partial response (PR)

• No response (NR) / stable disease (SD)

• Progressive disease (PD)

• Relapse from CR (Rel) (untreated)

• Unknown

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to signature line

YYYY MM DD

3. Specify amyloidosis hematologic response (for Amyloid patients only)

• Complete response (CR)

• Very good partial response (VGPR)

• Partial response (PR)

• No response (NR) / stable disease (SD)

• Progressive disease (PD)

• Relapse from CR (Rel) (untreated)

• Unknown

3. Date assessed: ___ ___ ___ ___ - ___ ___ - ___ ___ – Go to signature line

YYYY MM DD

Solid Tumors

3. Specify the solid tumor classification

• Bone sarcoma (excluding Ewing family tumors) (273)

• Breast cancer (250)

• Central nervous system tumor, including CNS PNET (220)

• Cervical (212)

• Colorectal (228)

• Ewing family tumors of bone (including PNET) (275)

• Ewing family tumors, extraosseous (including PNET) (276)

• External genitalia (211)

• Fibrosarcoma (244)

• Gastric (229)

• Germ cell tumor, extragonadal (225)

• Head / neck (201)

• Hemangiosarcoma (246)

• Hepatobiliary (207)

• Leiomyosarcoma (242)

• Liposarcoma (243)

• Lung, non-small cell (203)

• Lung, not otherwise specified (230)

• Lung, small cell (202)

• Lymphangio sarcoma (247)

• Mediastinal neoplasm (204)

• Medulloblastoma (226)

• Melanoma (219)

• Neuroblastoma (222)

• Neurogenic sarcoma (248)

• Ovarian (epithelial) (214)

• Pancreatic (206)

• Prostate (209)

• Renal cell (208)

• Retinoblastoma (223)

• Rhabdomyosarcoma (232)

• Soft tissue sarcoma (excluding Ewing family tumors) (274)

• Synovial sarcoma (245)

• Testicular (210)

• Thymoma (231)

• Uterine (213)

• Vaginal (215)

• Wilm tumor (221)

• Solid tumor, not otherwise specified (200)

• Other solid tumor (269) – Go to question 445

3. Specify other solid tumor: ________________________________- Go to signature line

Aplastic Anemia

446. Specify the aplastic anemia classification – If the recipient developed MDS or AML, indicate MDS or AML as the primary disease.

• Acquired AA, not otherwise specified (301) – Go to question 447

• Acquired AA secondary to chemotherapy (313) – Go to question 447

• Acquired AA secondary to hepatitis (302) (any form of hepatitis)– Go to question 447

• Acquired AA secondary to immunotherapy or immune effector cell therapy (314) – Go to question 447

• Acquired AA secondary to toxin / other drug (303) – Go to question 447

• Acquired amegakaryocytosis (not congenital) (304) – Go to Signature Line

• Acquired pure red cell aplasia (not congenital) (306) – Go to Signature Line

• Other acquired cytopenic syndrome (309) – Go to question 448

3. Specify severity

• Severe / very severe

• Not severe

3. Specify other acquired cytopenic syndrome: __________________________- Go to Signature Line

Inherited Bone Marrow Failure Syndromes

3. Specify the inherited bone marrow failure syndrome classification - If the recipient developed MDS or AML, indicate MDS or AML as the primary disease.

• Diamond-Blackfan anemia (pure red cell aplasia) (312) – Go to question 450

• Dyskeratosis congenita (307) – Go to signature line

• Fanconi anemia (311)– Go to question 450

• Severe congenital neutropenia (including Kostmann syndrome)(460) – Go to signature line

• Shwachman-Diamond (305) – Go to question 450

3. Did the recipient receive gene therapy to treat the inherited bone marrow failure syndrome?

• Yes - Also complete Cellular Therapy Product and Infusion forms 4003 and 4006.

• No

Hemoglobinopathies

3. Specify the hemoglobinopathy classification

• Sickle cell disease (356) – Go to question 454

• Transfusion dependent thalassemia (360) – Go to question 452

• Other hemoglobinopathy (359) – Go to question 453

3. Specify transfusion dependent thalassemia

• Transfusion dependent beta thalassemia (357) – Go to question 454

• Other transfusion dependent thalassemia (358) – Go to question 454

3. Specify other hemoglobinopathy:______

4. Did the recipient receive gene therapy to treat the hemoglobinopathy?

• Yes - Also complete Cellular Therapy Product and Infusion forms 4003 and 4006. If transfusion dependent thalassemia, go to question 455, else go to signature line

• No - If transfusion dependent thalassemia, go to question 455, else go to signature line

Questions 455-487 are for transfusion dependent thalassemia

3. Was tricuspid regurgitant jet velocity (TRJV) measured by echocardiography?

• Yes – Go to question 456

• No– Go to question 458

• Unknown - Go to question 458

3. TRJV measurement

• Known – Go to question 457

• Unknown– Go to question 458

3. TRJV measurement: __ __● ___ m/sec

4. Was liver iron content (LIC) tested within 6 months prior to infusion?

• Yes – Go to question 459

• No – Go to question 461

3. Liver iron content: ___ ___ ___ ● ___

• mg Fe/g liver dry weight

• g Fe/kg liver dry weight

• µmol Fe / g liver dry weight

3. Method used to estimate?

• T2*MRI

• SQUID MRI

• FerriScan

• Liver biopsy

• Other

3. Is the recipient red blood cell transfusion dependent? (requiring transfusion to maintain HGB 9-10 g/dL)

• Yes – Go to question 462

• No – Go to question 469

3. Year of first transfusion (since diagnosis): ___ ___ ___ ___

YYYY

3. Was iron chelation therapy given at any time since diagnosis?

• Yes – Go to question 464

• No – Go to question 469

• Unknown – Go to question 469

3. Did iron chelation therapy meet the following criteria: initiated within 18 months of the first transfusion and administered for at least 5 days / week (either oral or parenteral iron chelation medication)?

• Yes, iron chelation therapy given as specified – 467

• No, iron chelation therapy given, but does not meet criteria – Go to question 465

• Iron chelation therapy given, but details of administration unknown – Go to question 467

3. Specify reason criteria not met

• Non-adherence – Go to question 467

• Toxicity due to iron chelation therapy – Go to question 467

• Other – Go to question 466

3. Specify other reason criteria not met: ______________________

4. Year iron chelation therapy started

• Known – Go to question 468

• Unknown – Go to question 469

3. Year started: ___ ___ ___ ___

YYYY

3. Did the recipient have hepatomegaly? (> 2 cm below costal margin)

• Yes– Go to question 470

• No– Go to question 471

• Unknown– Go to question 471

3. Liver size as measured below the costal margin at most recent evaluation: ___ ___ ● ___ cm

4. Was a liver biopsy performed at any time since diagnosis?

• Yes – Go to questions 472

• No – Go to questions 479

3. Date assessed

• Known – Go to question 473

• Unknown – Go to question 474

3. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___ □ Date estimated

YYYY MM DD

3. Was there evidence of liver cirrhosis?

• Yes

• No

• Unknown

3. Was there evidence of liver fibrosis?

• Yes – Go to question 476

• No – Go to question 477

• Unknown – Go to question 477

3. Type of fibrosis

• Bridging

• Peri portal

• Other

• Unknown

3. Was there evidence of chronic hepatitis?

• Yes

• No

• Unknown

3. Was documentation submitted to the CIBMTR? (e.g., liver biopsy)

• Yes

• No

3. Is there evidence of abnormal cardiac iron deposition based on MRI of the heart at time of infusion?

• Yes

• No

3. Did the recipient have a splenectomy?

• Yes

• No

• Unknown

Laboratory studies at last evaluation prior to start of preparative regimen

3. Serum iron

• Known – Go to questions 482

• Unknown – Go to questions 483

3. ___ ___ ___● ___ ___  µg / dL

 µmol / L

3. Total iron binding capacity (TIBC)

• Known – Go to question 484

• Unknown – Go to question 485

3. ___ ___ ___ ● ___ ___  µg / dL

 µmol / L

3. Total serum bilirubin

• Known – Go to question 486

• Unknown – Go to question Signature line

3. ___ ___ ___ ● ___  mg/dL

 μmol/L

3. Upper limit of normal for your institution: ___ ___ ___ ● ___

Disorders of the Immune System

3. Specify disorder of immune system classification

• Adenosine deaminase (ADA) deficiency / severe combined immunodeficiency (SCID) (401) – Go to question 492

• Absence of T and B cells SCID (402) – Go to question 492

• Absence of T, normal B cell SCID (403) – Go to question 492

• Omenn syndrome (404) – Go to question 492

• Reticular dysgenesis (405) – Go to question 492

• Bare lymphocyte syndrome (406) – Go to question 492

• Other SCID (419) – Go to question 489

• SCID, not otherwise specified (410) – Go to question 492

• Ataxia telangiectasia (451) – Go to question 492

• HIV infection (452) – Go to question 492

• DiGeorge anomaly (454) – Go to question 492

• Common variable immunodeficiency (457) – Go to question 492

• Leukocyte adhesion deficiencies, including GP180, CD-18, LFA and WBC adhesion deficiencies (459) – Go to question 492

• Neutrophil actin deficiency (461) – Go to question 492

• Cartilage-hair hypoplasia (462) – Go to question 492

• CD40 ligand deficiency (464) – Go to question 492

• Other immunodeficiencies (479) – Go to question 490

• Immune deficiency, not otherwise specified (400) – Go to question 492

• Chediak-Higashi syndrome (456) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 492

• Griscelli syndrome type 2 (465) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 492

• Hermansky-Pudlak syndrome type 2 (466) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 492

• Other pigmentary dilution disorder (469) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 491

• Chronic granulomatous disease (455) – Go to question 492

• Wiskott-Aldrich syndrome (453) – Go to question 492

• X-linked lymphoproliferative syndrome (458) – Go to question 492

3. Specify other SCID: ____________________________ – Go to question 492

4. Specify other immunodeficiency: ____________________________– Go to question 492

5. Specify other pigmentary dilution disorder: ____________________________– Go to question 492

6. Did the recipient have an active or recent infection with a viral pathogen within 60 days of HCT?

• Yes– Go to question 493

• No– Go to question 494

3. Specify viral pathogen (check all that apply)

• 304 Adenovirus

• 341 BK Virus

• 344 Coronavirus

• 303 Cytomegalovirus (CMV)

• 347 Chikungunya Virus

• 346 Dengue Virus

• 325 Enterovirus (ECHO, Coxsackie)

• 327 Enterovirus D68 (EV-D68)

• 326 Enterovirus (polio)

• 328 Enterovirus NOS

• 318 Epstein-Barr Virus (EBV)

• 306 Hepatitis A Virus

• 307 Hepatitis B Virus

• 308 Hepatitis C Virus

• 340 Hepatitis E

• 301 Herpes Simplex Virus (HSV)

• 317 Human herpesvirus 6 (HHV-6)

• 309 Human Immunodeficiency Virus 1 or 2

• 343 Human metapneumovirus

• 322 Human Papillomavirus (HPV)

• 349 Human T-lymphotropic Virus 1 or 2

• 310 Influenza, NOS

• 323 Influenza A Virus

• 324 Influenza B Virus

• 342 JC Virus (Progressive Multifocal Leukoencephalopathy (PML))

• 311 Measles Virus (Rubeola)

• 312 Mumps Virus

• 345 Norovirus

• 316 Human Parainfluenza Virus (all species)

• 314 Respiratory Syncytial Virus (RSV)

• 321 Rhinovirus (all species)

• 320 Rotavirus (all species)

• 315 Rubella Virus

• 302 Varicella Virus

• 348 West Nile Virus (WNV)

3. Has the recipient ever been infected with PCP/PJP?

• Yes

• No

3. Does the recipient have GVHD due to maternal cell engraftment pre-HCT? (SCID only)

• Yes

• No

Inherited Abnormalities of Platelets

3. Specify inherited abnormalities of platelets classification

 Congenital amegakaryocytosis / congenital thrombocytopenia (501)

 Glanzmann thrombasthenia (502)

 Other inherited platelet abnormality (509) – Go to question 497

3. Specify other inherited platelet abnormality: ________________________________- Go to signature line

Inherited Disorders of Metabolism

3. Specify inherited disorders of metabolism classification

• Osteopetrosis (malignant infantile osteopetrosis) (521)

Leukodystrophies

• Metachromatic leukodystrophy (MLD) (542)

• Adrenoleukodystrophy (ALD) (543) – Go to question 500

• Krabbe disease (globoid leukodystrophy) (544)

• Lesch-Nyhan (HGPRT deficiency) (522)

• Neuronal ceroid lipofuscinosis (Batten disease) (523)

Mucopolysaccharidoses

• Hurler syndrome (IH) (531)

• Scheie syndrome (IS) (532)

• Hunter syndrome (II) (533)

• Sanfilippo (III) (534)

• Morquio (IV) (535)

• Maroteaux-Lamy (VI) (536)

• β-glucuronidase deficiency (VII) (537)

• Mucopolysaccharidosis (V) (538)

• Mucopolysaccharidosis, not otherwise specified (530)

Mucolipidoses

• Gaucher disease (541)

• Niemann-Pick disease (545)

• I-cell disease (546)

• Wolman disease (547)

• Glucose storage disease (548)

• Mucolipidoses, not otherwise specified (540)

Polysaccharide hydrolase abnormalities

• Aspartyl glucosaminidase (561)

• Fucosidosis (562)

• Mannosidosis (563)

• Polysaccharide hydrolase abnormality, not otherwise specified (560)

• Other inherited metabolic disorder (529) – Go to question 499

• Inherited metabolic disorder, not otherwise specified (520)

3. Specify other inherited metabolic disorder: __________________________ - Go to signature line

4. Loes composite score: __ __ Adrenoleukodystrophy (ALD) only - Go to signature line

Histiocytic Disorders

3. Specify histiocytic disorder classification

 Hemophagocytic lymphohistiocytosis (HLH) (571) – Go to question 503

 Langerhans cell histiocytosis (histiocytosis-X) (572)

 Hemophagocytosis (reactive or viral associated) (573)

 Malignant histiocytosis (574)

 Other histiocytic disorder (579) – Go to question 502

 Histiocytic disorder, not otherwise specified (570)

3. Specify other histiocytic disorder: ____________________________________- Go to signature line

4. Did the recipient have an active or recent infection with a viral pathogen within 60 days of HCT? Hemophagocytic lymphohistiocytosis (HLH) only

• Yes– Go to question 504

• No– Go to question 505

3. Specify viral pathogen (check all that apply)

• 304 Adenovirus

• 341 BK Virus

• 344 Coronavirus

• 303 Cytomegalovirus (CMV)

• 347 Chikaugunya Virus

• 346 Dengue Virus

• 325 Enterovirus (ECHO, Coxsackie)

• 327 Enterovirus D68 (EV-D68)

• 326 Enterovirus (polio)

• 328 Enterovirus NOS

• 318 Epstein-Barr Virus (EBV)

• 306 Hepatitis A Virus

• 307 Hepatitis B Virus

• 308 Hepatitis C Virus

• 340 Hepatitis E

• 301 Herpes Simplex Virus (HSV)

• 317 Human herpesvirus 6 (HHV-6)

• 309 Human Immunodeficiency Virus 1 or 2

• 343 Human metapneumovirus

• 322 Human Papillomavirus (HPV)

• 349 Human T-lymphotropic Virus 1 or 2

• 310 Influenza, NOS

• 323 Influenza A Virus

• 324 Influenza B Virus

• 342 JC Virus (Progressive Multifocal Leukoencephalopathy (PML))

• 311 Measles Virus (Rubeola)

• 312 Mumps Virus

• 345 Norovirus

• 316 Human Parainfluenza Virus (all species)

• 314 Respiratory Syncytial Virus (RSV)

• 321 Rhinovirus (all species)

• 320 Rotavirus (all species)

• 315 Rubella Virus

• 302 Varicella Virus

• 348 West Nile Virus (WNV)

3. Has the recipient ever been infected with PCP/PJP

• Yes- Go to signature line

• No- Go to signature line

Autoimmune Diseases

3. Specify autoimmune disease classification

Arthritis

• Rheumatoid arthritis (603)

• Psoriatic arthritis / psoriasis (604)

• Juvenile idiopathic arthritis (JIA): systemic (Stills disease) (640)

• Juvenile idiopathic arthritis (JIA): oligoarticular (641)

• Juvenile idiopathic arthritis (JIA): polyarticular (642)

• Juvenile idiopathic arthritis (JIA): other (643)

• Other arthritis (633)

Multiple sclerosis

• Multiple sclerosis (602)

Connective tissue diseases

• Systemic sclerosis (scleroderma) (607)

• Systemic lupus erythematosis (SLE) (605)

• Sjögren syndrome (608)

• Polymyositis / dermatomyositis (606)

• Antiphospholipid syndrome (614)

• Other connective tissue disease (634)

Vasculitis

• Wegener granulomatosis (610)

• Classical polyarteritis nodosa (631)

• Microscopic polyarteritis nodosa (632)

• Churg-Strauss (635)

• Giant cell arteritis (636)

• Takayasu (637)

• Behcet syndrome (638)

• Overlap necrotizing arteritis (639)

• Other vasculitis (611)

Other neurological autoimmune diseases

• Myasthenia gravis (601)

• Other autoimmune neurological disorder (644)

Hematological autoimmune diseases

• Idiopathic thrombocytopenic purpura (ITP) (645)

• Hemolytic anemia (646)

• Evan syndrome (647)

• Other autoimmune cytopenia (648) – Go to question 507

Bowel diseases

• Crohn’s disease (649)

• Ulcerative colitis (650)

• Other autoimmune bowel disorder (651) – Go to question 508

Metabolic

• Diabetes mellitus type 1 (660)

Other

• Other autoimmune disease (629) – Go to question 509

3. Specify other autoimmune cytopenia:_________________________________

4. Specify other autoimmune bowel disorder:_________________________________

5. Specify other autoimmune disease: ____________________

- Go to signature line

Tolerance Induction Associated with Solid Organ Transplant

3. Specify solid organ transplanted (check all that apply)

• Kidney

• Liver

• Pancreas

• Other organ - Go to question 511

3. Specify other organ: ______________________ - Go to signature line

Other Disease

3. Specify other disease: _________________________________________- Go to signature line

First Name: ____________________________________________________________________________

Last Name:

E-mail address:

Date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

CIBMTR Form 2402 revision 6 (1 – 102) Draft 7/14/2020

Copyright © 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.