Draft 2402 r3- Pre-TED Disease (OMB doc 12-05-17)

Draft 2402 r3- Pre-TED Disease (OMB doc 12-05-17).docx

Stem Cell Therapeutic Outcomes Database

Draft 2402 r3- Pre-TED Disease (OMB doc 12-05-17).docx

OMB: 0915-0310

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Shape2

Disease Classification




Shape1

OMB No: 0915-0310

Expiration Date: 1/31/2020


Public Burden Statement: 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 project is 0915-0310. Public reporting burden for this collection of information is estimated to average 0.85 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 10-33, Rockville, Maryland, 20857.

Expiration date:

CIBMTR Use Only

Sequence Number:





Date Received:





CIBMTR Center Number: ___ ___ ___ ___ ___

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

Event date: ___ ___ ___ ___ - ___ ___ - ___ ___







































Primary Disease for HCT / Cellular Therapy

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

YYYY MM DD

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 90

Acute leukemia of ambiguous lineage and other myeloid neoplasms (80) - Go to question 152

Chronic myelogenous leukemia (CML) (40) - Go to question 156

Myelodysplastic (MDS) / myeloproliferative (MPN) diseases (50) (Please classify all preleukemias)
(If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 167

Other leukemia (30) (includes CLL) - Go to question 261

Hodgkin lymphoma (150) - Go to question 268

Non-Hodgkin lymphoma (100) - Go to question 268

Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 268

Solid tumors (200) - Go to question 300

Severe aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease) - Go to question 302

Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 304

Disorders of the immune system (400) - Go to question 307

Inherited abnormalities of platelets (500) - Go to question 310

Inherited disorders of metabolism (520) - Go to question 312

Histiocytic disorders (570) - Go to question 314

Autoimmune diseases (600) - Go to question 316

Other disease (900) - Go to question 324





Acute Myelogenous Leukemia (AML)



  1. 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)



  1. Did AML transform from MDS or MPN?

Yes – Also complete MDS Disease Classification questions

No

  1. Is the disease (AML) therapy related?

Yes

No

Unknown

  1. Did the recipient have a predisposing condition?

Yes - Go to question 7

No - Go to question 9

Unknown - Go to question 9

  1. 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

  1. Specify other condition: __________________________________________



Labs at diagnosis

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

Yes - Go to question 10

No - Go to question 21

Unknown - Go to question 21

  1. Were cytogenetics tested via FISH?

Yes – Go to question 11

No - Go to question 15

  1. Results of tests:

Abnormalities identified – Go to question 12

No abnormalities - Go to question 15

Specify cytogenetic abnormalities identified at diagnosis:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 14

  1. Specify other abnormality: _____________________





  1. Were cytogenetics tested via karyotyping?

Yes – Go to question 16

No - Go to question 20

  1. Results of tests:

Abnormalities identified – Go to question 17

No evaluable metaphases - Go to question 21

No abnormalities - Go to question 21

Specify cytogenetic abnormalities identified at diagnosis:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 19

  1. Specify other abnormality: _____________________

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

 Yes

No



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

Yes – Go to question 22

No – Go to question 34

Unknown – Go to question 34

Specify molecular markers identified at diagnosis:

  1. CEBPA

Positive – Go to question 23

Negative - Go to question 24

Not done - Go to question 24

  1. Specify CEBPA mutation

Biallelic (homozygous)

Monoallelic (heterozygous)

Unknown

  1. FLT3 – D835 point mutation

Positive

Negative

Not done

  1. FLT3 – ITD mutation

Positive- Go to question 26

Negative- Go to question 26

Not done- Go to question 27

  1. FLT3 – ITD allelic ratio

Known - Go to question 27

Unknown - Go to question 28

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

  2. IDH1

Positive

Negative

Not done

  1. IDH2

Positive

Negative

Not done

  1. KIT

Positive

Negative

Not done

  1. NPM1

Positive

Negative

Not done

  1. Other molecular marker

Positive- Go to question 33

Negative- Go to question 33

Not done- Go to question 34

  1. Specify other molecular marker: _________________________________

Copy and complete questions 32-33 for multiple molecular markers

Labs between diagnosis and last evaluation:

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

Yes - Go to question 35

No - Go to question 46

Unknown - Go to question 46

  1. Were cytogenetics tested via FISH?

Yes – Go to question 36

No - Go to question 40

  1. Results of tests:

Abnormalities identified – Go to question 37

No abnormalities - Go to question 40

Specify cytogenetic abnormalities identified between diagnosis and last evaluation:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 39

  1. Specify other abnormality: _____________________

  2. Were cytogenetics tested via karyotyping?

Yes – Go to question 41

No - Go to question 45

  1. Results of tests:

Abnormalities identified – Go to question 42

No evaluable metaphases - Go to question 46

No abnormalities - Go to question 46

Specify cytogenetic abnormalities identified between diagnosis and last evaluation:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 44

  1. Specify other abnormality: _____________________

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

 Yes

No



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

Yes – Go to question 47

No – Go to question 59

Unknown – Go to question 59

Specify molecular markers identified between diagnosis and last evaluation:

  1. CEBPA

Positive – Go to question 48

Negative - Go to question 49

Not done - Go to question 49

  1. Specify CEBPA mutation

Biallelic (homozygous)

Monoallelic (heterozygous)

Unknown

  1. FLT3 – D835 point mutation

Positive

Negative

Not done

  1. FLT3 – ITD mutation

Positive - Go to question 51

Negative - Go to question 53

Not done - Go to question 53

  1. FLT3 – ITD allelic ratio

Known - Go to question 52

Unknown - Go to question 53

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



  1. IDH1

Positive

Negative

Not done

  1. IDH2

Positive

Negative

Not done

  1. KIT

Positive

Negative

Not done

  1. NPM1

Positive

Negative

Not done

  1. Other molecular marker

Positive- Go to question 58

Negative- Go to question 58

Not done- Go to question 59

  1. Specify other molecular marker: _________________________________

Copy and complete questions 57-58 to report multiple other molecular markers



Labs at last evaluation:

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

Yes - Go to question 60

No - Go to question 71

Unknown - Go to question 71

  1. Were cytogenetics tested via FISH?

Yes – Go to question 61

No - Go to question 65

  1. Results of tests:

Abnormalities identified – Go to question 62

No abnormalities - Go to question 65

Specify cytogenetic abnormalities identified at last evaluation:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 64

  1. Specify other abnormality: _____________________



  1. Were cytogenetics tested via karyotyping?

Yes – Go to question 66

No - Go to question 71

  1. Results of tests:

Abnormalities identified – Go to question 67

No evaluable metaphases - Go to question 71

No abnormalities - Go to question 71

Specify cytogenetic abnormalities identified at last evaluation:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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

  1. Specify other abnormality: _____________________

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

 Yes

No



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

Yes – Go to question 72

No – Go to question 84

Unknown – Go to question 84

Specify molecular markers identified at last evaluation:

  1. CEBPA

Positive – Go to question 73

Negative - Go to question 74

Not done - Go to question 74

  1. Specify CEBPA mutation

Biallelic (homozygous)

Monoallelic (heterozygous)

Unknown

  1. FLT3 – D835 point mutation

Positive

Negative

Not done

  1. FLT3 – ITD mutation

Positive - Go to question 76

Negative - Go to question 78

Not done - Go to question 78

  1. FLT3 – ITD allelic ratio

Known - Go to question 77

Unknown - Go to question 78

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



  1. IDH1

Positive

Negative

Not done

  1. IDH2

Positive

Negative

Not done

  1. KIT

Positive

Negative

Not done

  1. NPM1

Positive

Negative

Not done

  1. Other molecular marker

Positive- Go to question 83

Negative- Go to question 83

Not done- Go to question 84

  1. Specify other molecular marker: _________________________________

Copy and complete questions 82-83 to report multiple other molecular markers



CNS Leukemia

  1. 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:

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

 Primary induction failure – Go to question 89

1st complete remission (no previous bone marrow or extramedullary relapse) (include CRi)– Go to question 86

2nd complete remission – Go to question 86

≥ 3rd complete remission – Go to question 86

1st relapse – Go to question 88

2nd relapse – Go to question 88

≥ 3rd relapse – Go to question 88

No treatment – Go to question 89

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

1

2

≥ 3

  1. Was the recipient in remission by flow cytometry?

Yes – Go to question 89

No – Go to question 89

Unknown – Go to question 89

Not applicable – Go to question 89

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

YYYY MM DD

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

YYYY MM DD



Acute Lymphoblastic Leukemia (ALL)



  1. 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 (<45 chromosomes) (83)

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

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

T-cell lymphoblastic leukemia / lymphoma

Early T-cell precursor lymphoblastic leukemia (provisional entity) (96)

Natural killer (NK)- cell lymphoblastic leukemia / lymphoma (provisional entity) (97)

  1. Did the recipient have a predisposing condition?

Yes - Go to question 92

No - Go to question 94

Unknown - Go to question 94

  1. Specify condition:

Aplastic anemia - Go to question 94 Also complete CIBMTR Form 2028 — APL

Bloom syndrome - Go to question 94

Down syndrome - Go to question 94

Fanconi anemia - Go to question 924 Also complete CIBMTR Form 2029 — FAN

Other condition - Go to question 93

  1. Specify other condition:

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

Yes

No



Laboratory studies at diagnosis:

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

Yes - Go to question 96

No - Go to question 106

Unknown - Go to question 106

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

Yes - Go to question 97

No - Go to question 101

  1. Results of tests: (at diagnosis)

Abnormalities identified - Go to question 98

No abnormalities - Go to question 101

Specify cytogenetic abnormalities identified:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 (< 45)

iAMP21

Other abnormality – Go to question 100

  1. Specify other abnormality:

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

Yes - Go to question 102

No - Go to question 107

  1. Results of tests: (at diagnosis)

Abnormalities identified - Go to question 103

No evaluable metaphases - Go to question 107

No abnormalities - Go to question 107

Specify cytogenetic abnormalities identified:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 (< 45)

iAMP21

Other abnormality – Go to question 105

  1. Specify other abnormality: _________________________

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

 Yes

No



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

Yes – Go to question 108

No – Go to question 113

Unknown – Go to question 113

Specify molecular markers identified at diagnosis:

  1. BCR / ABL

Positive

Negative

Not done

  1. TEL-AML / AML1

Positive

Negative

Not done

  1. Other molecular marker

Positive – Go to question 111

Negative – Go to question 111

Not done – Go to question 112

  1. Specify other molecular marker:

Copy and complete questions 110-111 for additional molecular markers



Laboratory studies between diagnosis and last evaluation:

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

Yes - Go to question 113

No - Go to question 124

Unknown - Go to question 124

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

Yes - Go to question 114

No - Go to question 118

  1. Results of tests: (between diagnosis and the last evaluation)

Abnormalities identified - Go to question 115

No abnormalities - Go to question 118

Specify cytogenetic abnormalities identified:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 (< 45)

iAMP21

Other abnormality – Go to question 117

  1. Specify other abnormality:

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

Yes - Go to question 119

No - Go to question 124

  1. Results of tests: (between diagnosis and the last evaluation)

Abnormalities identified - Go to question 120

No evaluable metaphases - Go to question 124

No abnormalities - Go to question 124

Specify cytogenetic abnormalities identified:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 (< 45)

iAMP21

Other abnormality – Go to question 122

  1. Specify other abnormality:

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

 Yes

No

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

Yes – Go to question 125

No – Go to question 129

Unknown – Go to question 129

Specify molecular markers identified between diagnosis and last evaluation:

  1. BCR / ABL

Positive

Negative

Not done

  1. TEL-AML / AML1

Positive

Negative

Not done

  1. Other molecular marker

Positive – Go to question 128

Negative – Go to question 128

Not done – Go to question 129

  1. Specify other molecular marker:

Copy and complete questions 127-128 for additional molecular markers

Laboratory studies at last evaluation:

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

Yes - Go to question 130

No - Go to question 141

Unknown - Go to question 141

  1. Were cytogenetics tested via FISH?

Yes - Go to question 131

No - Go to question 135

  1. Results of tests:

Abnormalities identified - Go to question 132

No abnormalities - Go to question 135

Specify cytogenetic abnormalities identified at last evaluation:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 (< 45)

iAMP21

Other abnormality – Go to question 134

  1. Specify other abnormality:

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

Yes - Go to question 136

No - Go to question 141

  1. Results of tests:

Abnormalities identified - Go to question 137

No evaluable metaphases - Go to question 141

No abnormalities - Go to question 141

Specify cytogenetic abnormalities identified at last evaluation:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

  1. 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 (< 45)

iAMP21

Other abnormality – Go to question 139

  1. Specify other abnormality:

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

Yes

No

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

Yes – Go to question 142

No – Go to question 146

Unknown – Go to question 146

Specify molecular markers identified at last evaluation:

  1. BCR / ABL

Positive

Negative

Not done

  1. TEL-AML / AML1

Positive

Negative

Not done

  1. Other molecular marker

Positive – Go to question 145

Negative – Go to question 145

Not done – Go to question 146

  1. Specify other molecular marker:

Copy and complete questions 144-145 for additional molecular markers

CNS Leukemia

  1. 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:

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

Primary induction failure – Go to question 151

1st complete remission (no previous marrow or extramedullary relapse)(include CRi) – Go to question 148

2nd complete remission – Go to question 148

3rd complete remission – Go to question 148

1st relapse – Go to question 150

2nd relapse – Go to question 150

3rd relapse – Go to question 150

No treatment – Go to question 151

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

1

2

≥ 3



  1. Was the recipient in remission by flow cytometry?

Yes – Go to question 151

No – Go to question 151

Unknown – Go to question 151

Not applicable – Go to question 151

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

YYYY MM DD

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

YYYY MM DD



Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms



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

Blastic plasmacytoid dendritic cell neoplasm (296)– Go to question 154

 Acute undifferentiated leukemia (31) Go to question 154

Mixed phenotype acute leukemia (MPAL) with t(9;22)(q34.1;q11.2); BCR-ABL1 (84) – Go to question 154

Mixed phenotype acute leukemia with t(v; 11q23.3); KMT2A rearranged (85) – Go to question 154

Mixed phenotype acute leukemia, B/myeloid, NOS (86) – Go to question 154

Mixed phenotype acute leukemia, T/myeloid, NOS (87) – Go to question 154

Other acute leukemia of ambiguous lineage or myeloid neoplasm (88) - Go to question 153



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

Status at transplantation:

  1. 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

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

YYYY MM DD



Chronic Myelogenous Leukemia (CML)

  1. Was therapy given prior to this HCT?

Yes - Go to questions 157

No - Go to question 163

  1. Combination chemotherapy

Yes

No

  1. Hydroxyurea (Droxia, Hydrea)

Yes

No

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

Yes

No

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

Yes

No

  1. Other therapy

Yes - Go to question 162

No - Go to question 163

  1. Specify other therapy: ______________________________________

  2. What was the disease status?

 Complete hematologic response (CHR) - Go to question 164

 Chronic phase – Go to question 164

 Accelerated phase - Go to question 165

 Blast phase - Go to question 165

  1. 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)

  1. Number

1st

2nd

3rd or higher

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

YYYY MM DD



Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases



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

Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51)

Refractory anemia with ringed sideroblasts (RARS) (55)

Refractory anemia with excess blasts-1 (RAEB-1) (61)

Refractory anemia with excess blasts-2 (RAEB-2) (62)

Refractory cytopenia with multilineage dysplasia (RCMD) (64)

Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68)

Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66)

Myelodysplastic syndrome (MDS), unclassifiable (50)

Chronic neutrophilic leukemia (165)

Chronic eosinophilic leukemia, NOS (166)

Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58)

Polycythemia vera (PCV) (57)

Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid metaplasia (AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)

Mastocytosis

Myeloproliferative neoplasm (MPN), unclassifiable (60)

Myeloid/lymphoid neoplasms with PDGFRA rearrangement

Myeloid/lymphoid neoplasms with PDGFRB rearrangement

Myeloid/lymphoid neoplasms with FGFR1 rearrangement

Myeloid/lymphoid neoplasms with PCM1-JAK2-

Chronic myelomonocytic leukemia (CMMoL) (54)

Juvenile myelomonocytic leukemia (JMML/JCML) (no evidence of Ph1 or BCR/ABL) (36) – Go to question 212

Atypical chronic myeloid leukemia (aCML), BCR-ABL1- – Go to question 265

MDS / MPN with ring sideroblasts and thrombocytosis (MDS / MPN–RS–T)

Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69)

  1. Was the disease (MDS/MPN) therapy related?

Yes

No

Unknown

  1. Did the recipient have a predisposing condition?

Yes Go to question 168

No Go to question 170

Unknown Go to question 170

  1. Specify condition:

Aplastic anemia Go to question 172

Bloom syndrome Go to question 172

Down syndrome Go to question 172

Fanconi anemia – – Go to question 172

Other condition – Go to question 171

  1. Specify other condition:

Laboratory studies at diagnosis of MDS:

  1. WBC

Known

Unknown

  1. ___ ___ ___ ___ ___ ___ ● ___ x 109/L (x 103/mm3)

x 106/L

  1. Hemoglobin

Known

Unknown

  1. ___ ___ ___ ___ ● ___ ___ g/dL

g/L

mmol/L

  1. Was RBC transfused ≤ 30 days before date of test?

Yes

No

  1. Platelets

Known

 Unknown

  1. ___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)

x 106/L

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

Yes

No

  1. Neutrophils

Known

Unknown

  1. ___ ___%

  2. Blasts in bone marrow

 Known

Unknown

  1. ___ ___ ___ %

  2. Were cytogenetics tested (karyotyping or FISH)?

Yes – Go to question 185

No – Go to question 212

Unknown – Go to question 212

  1. Results of tests:

Abnormalities identified – Go to question 186

No evaluable metaphases – Go to question 212

No abnormalities – Go to question 212



Specify abnormalities identified at diagnosis:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

Monosomy

  1. –5

Yes

No

  1. –7

Yes

No

  1. –13

Yes

No

  1. –20

Yes

No

  1. –Y

Yes

No

Trisomy



  1. +8

Yes

No

  1. +19

Yes

No

Translocation

  1. t(1;3)

Yes

No

  1. t(2;11)

Yes

No

  1. t(3;3)

Yes

No

  1. t(3;21)

Yes

No

  1. t(6;9)

Yes

No

  1. t(11;16)

Yes

No

Deletion

  1. del(3q) / 3q-

Yes

No

  1. del(5q) / 5q-

Yes –

No

  1. del(7q) / 7q-

Yes

No

  1. del(9q) / 9q-

Yes

No

  1. del(11q) / 11q-

Yes

No

  1. del(12p) / 12p-

Yes

No

  1. del(13q) / 13q-

Yes

No

  1. del(20q) / 20q-

Yes

No

Inversion

  1. inv(3)

Yes

No

Other

  1. i17q

Yes

No

  1. Other abnormality

Yes – Go to question 211

No – Go to question 212

  1. Specify other abnormality:



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

Yes – Go to question 213

No – Go to question 216

  1. Specify the MDS / MPN subtype after transformation:

Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51)Go to question 214

Refractory anemia with ringed sideroblasts (RARS) (55)Go to question 214

Refractory anemia with excess blasts-1 (RAEB-1) (61)Go to question 214

Refractory anemia with excess blasts-2 (RAEB-2) (62)Go to question 214

Refractory cytopenia with multilineage dysplasia (RCMD) (64)Go to question 214

Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68)Go to question 214

Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66)Go to question 214

Myelodysplastic syndrome (MDS), unclassifiable (50)Go to question 214

Chronic neutrophilic leukemia (165)Go to question 214

Chronic eosinophilic leukemia, NOS (166)Go to question 214

Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58)Go to question 214

Polycythemia vera (PCV) (57)Go to question 214

Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid metaplasia (AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167)Go to question 214

Mastocytosis

Myeloproliferative neoplasm (MPN), unclassifiable (60)Go to question 214

Myeloid/lymphoid neoplasms with PDGFRA rearrangement

Myeloid/lymphoid neoplasms with PDGFRB rearrangement

Myeloid/lymphoid neoplasms with FGFR1 rearrangement

Myeloid/lymphoid neoplasms with PCM1-JAK2-

Chronic myelomonocytic leukemia (CMMoL) (54)Go to question 214

Atypical chronic myeloid leukemia (aCML), BCR-ABL1- – Go to question 265

MDS / MPN with ring sideroblasts and thrombocytosis (MDS / MPN–RS–T)

Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69) Go to question 214

Transformed to AML (70) Go to question 215

  1. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 216

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



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

  1. WBC

Known

Unknown

  1. ___ ___ ___ ___ ___ ___ ● ___ x 109/L (x 103/mm3)

x 106/L

  1. Hemoglobin

Known

Unknown

  1. ___ ___ ___ ___ ● ___ ___ g/dL

g/L

mmol/L

  1. Was RBC transfused ≤ 30 days before date of test?

Yes

No

  1. Platelets

Known

 Unknown

  1. ___ ___ ___ ___ ___ ___ ___ x 109/L (x 103/mm3)

x 106/L

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

Yes

No

  1. Neutrophils

Known

Unknown

  1. ___ ___%

  2. Blasts in bone marrow

 Known

Unknown

  1. ___ ___ ___ %



  1. Were cytogenetics tested (karyotyping or FISH)?

Yes – Go to question 229

No – Go to question 256

Unknown – Go to question 256

  1. Results of tests:

Abnormalities identified – Go to question 230

No evaluable metaphases – Go to question 256

No abnormalities – Go to question 256



Specify cytogenetic abnormalities identified at last evaluation prior to the start of the preparative regimen:

  1. Specify number of distinct cytogenetic abnormalities:

One (1)

Two (2)

Three (3)

Four or more (4 or more)

Monosomy


  1. –5

Yes

No

  1. –7

Yes

No

  1. –13

Yes

No

  1. –20

Yes

No

  1. –Y

Yes

No

Trisomy



  1. +8

Yes

No

  1. +19

Yes

No

Translocation

  1. t(1;3)

Yes

No

  1. t(2;11)

Yes

No

  1. t(3;3)

Yes

No

  1. t(3;21)

Yes

No

  1. t(6;9)

Yes

No

  1. t(11;16)

Yes

No

Deletion

  1. del(3q) / 3q-

Yes

No

  1. del(5q) / 5q-

Yes

No

  1. del(7q) / 7q-

Yes

No

  1. del(9q) / 9q-

Yes

No

  1. del(11q) / 11q-

Yes

No

  1. del(12p) / 12p-

Yes

No

  1. del(13q) / 13q-

Yes

No

  1. del(20q) / 20q-

Yes

No

Inversion

  1. inv(3)

Yes

No

Other

  1. i17q

Yes

No

  1. Other abnormality

Yes – Go to question 255

No – Go to question 256

  1. Specify other abnormality:

Status at transplantation:

  1. What was the disease status?

Complete remission (CR) – requires all of the following, maintained for ≥ 4 weeks: * bone marrow evaluation: < 5% myeloblasts with normal maturation of all cell lines * peripheral blood evaluation: hemoglobin ≥ 11 g/dL untransfused and without erythropoietin support; ANC ≥ 1000/mm3 without myeloid growth factor support; platelets ≥ 100 x 109/L without thrombopoietic support; 0% blasts - Go to question 260

Hematologic improvement (HI) requires one measurement of the following, maintained for ≥ 8 weeks without ongoing cytotoxic therapy; specify which cell line was measured to determine HI response: * HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks * HI-P – for pre-treatment platelet count of > 20 x 109/L, platelet absolute increase of ≥ 30 x 109/L; for pre-treatment platelet count of < 20 x 109/L, platelet absolute increase of ≥ 20 x 109/L and ≥ 100% from pre-treatment level * HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥ 500/mm3 - Go to question 257

No response (NR) / stable disease (SD) – does not meet the criteria for at least HI, but no evidence of disease progression - Go to question 260

Progression from hematologic improvement (Prog from HI) – requires at least one of the following, in the absence of another explanation (e.g., infection, bleeding, ongoing chemotherapy, etc.): * ≥ 50% reduction from maximum response levels in granulocytes or platelets * reduction in hemoglobin by ≥ 1.5 g/dL *transfusion dependence - Go to question 258

Relapse from complete remission (Rel from CR) – requires at least one of the following: * return to pre-treatment bone marrow blast percentage * decrease of ≥ 50% from maximum response levels in granulocytes or platelets * transfusion dependence, or hemoglobin level ≥ 1.5 g/dL lower than prior to therapy - Go to question 259

Not assessed - Go to signature line

  1. Specify the cell line examined to determine HI status:

 HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks - Go to question 260

 HI-P for pre-treatment platelet count of > 20 x 109/L, platelet absolute increase of ≥ 30 x 109/L; for pre-treatment platelet count of < 20 x 109/L, platelet absolute increase of ≥ 20 x 109/L and ≥ 100% from pre-treatment levelGo to question 260

 HI-N neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥ 500/mm3 - Go to question 260

  1. Date of progression: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 260

YYYY MM DD

  1. Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 260

YYYY MM DD

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

YYYY MM DD





Other Leukemia (OL)



  1. Specify the other leukemia classification:

Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 263

Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 263

Hairy cell leukemia (35) - Go to question 266

 Hairy cell leukemia variant (75) - Go to question 266

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

Prolymphocytic leukemia (PLL), NOS (37) - Go to question 263

PLL, B-cell (73) - Go to question 263

PLL, T-cell (74) - Go to question 263

Other leukemia, NOS (30) - Go to question 265

Other leukemia (39) - Go to question 262

  1. Specify other leukemia: – Go to question 265

  2. Was any 17p abnormality detected?

Yes – If disease classification is CLL, go to question 264. If PLL, go to question 266

No

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

Yes – Go to question 271– Also complete NHL Disease Classification questions

No – Go to question 266

Status at transplantation:

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

Primary induction failure – Go to question 267

1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 267

2nd complete remission – Go to question 267

≥ 3rd complete remission – Go to question 267

1st relapse – Go to question 267

2nd relapse – Go to question 267

≥ 3rd relapse – Go to question 267

No treatment – Go to signature line

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

Complete remission (CR) – Go to question 267

Partial remission (PR) – Go to question 267

Stable disease (SD) – Go to question 267

Progressive disease (Prog) – Go to question 267

Untreated - Go to question 267

Not assessed - Go to signature line

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

YYYY MM DD

Hodgkin and Non-Hodgkin Lymphoma

  1. Specify the lymphoma histology: (at transplant)

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 (cell of origin unknown) (107)

  • Diffuse, large B-cell lymphoma- Germinal center B-cell type (1820)Go to question 270

  • Diffuse, large B-cell lymphoma- Activated B-cell type (non-GCB) (1821)Go to question 270

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

  • 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 (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 follicle center lymphoma (1817)

  • Primary cutaneous DLBCL, leg type (1822)

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

  • Primary effusion lymphoma (138)

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

  • Splenic marginal zone B-cell lymphoma (124)

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

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

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

  • Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173)

  • Other B-cell lymphoma (129) Go to question 269


T-cell and NK-cell Neoplasms

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

  • Aggressive NK-cell leukemia (27)

  • Angioimmunoblastic T-cell lymphoma (131)

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

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

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

  • Chronic lymphoproliferative disorder of NK cells (1856)

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

  • Enteropathy-type T-cell lymphoma (133)

  • 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 γδ T-cell lymphoma (1851)

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

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

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

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

  • 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 269


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)

  1. Specify other lymphoma histology: ______________________ Go to question 271



  1. 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

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

Yes – Go to question 272

No - Go to question 273

  1. Was any 17p abnormality detected?

 Yes– Go to question 277

 No– Go to question 277

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

Yes – Go to question 274

No – Go to question 277

  1. Specify the original lymphoma histology: (prior to transformation) same option list as Q268

  2. Specify other lymphoma histology:________________

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



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

Yes – Go to question 278

No – Go to question 283

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

Yes

No

  1. Date of PET scan

Known– Go to question 280

Unknown – Go to question 281

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

YYYY MM DD

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

Known – Go to question 282

Unknown – Go to question 283

  1. 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:

  1. What was the disease status?

Disease untreated– Go to question 285

PIF res - Primary induction failure – resistant: NEVER in COMPLETE remission but with stable or progressive disease on treatment. – Go to question 284

 PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial remission on treatment. – Go to question 284

PIF unk - Primary induction failure – sensitivity unknown– Go to question 284

CR1 - 1st complete remission: no bone marrow or extramedullary relapse prior to transplant– Go to question 284

CR2 - 2nd complete remission– Go to question 284

CR3+ - 3rd or subsequent complete remission– Go to question 284

REL1 unt - 1st relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 284

REL1 res - 1st relapse – resistant: stable or progressive disease with treatment– Go to question 284

REL1 sen - 1st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2) – Go to question 284

REL1 unk - 1st relapse – sensitivity unknown– Go to question 284

REL2 unt - 2nd relapse – untreated: includes either bone marrow or extramedullary relapse– Go to question 284

REL2 res - 2nd relapse – resistant: stable or progressive disease with treatment– Go to question 284

REL2 sen - 2nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 284

REL2 unk - 2nd relapse – sensitivity unknown– Go to question 284

REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 284

REL3+ res - 3rd or subsequent relapse – resistant: stable or progressive disease with treatment– Go to question 284

REL3+ sen - 3rd or subsequent relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 284

REL3+ unk - 3rd relapse or greater – sensitivity unknown– Go to question 284

  1. Total number of lines of therapy received: (at any time between diagnosis and HCT / infusion)

1 line

2 lines

3+ lines

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



Multiple Myeloma / Plasma Cell Disorder (PCD)


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

Multiple myeloma-lgG (181) - Go to questions 289

Multiple myeloma-lgA (182) - Go to questions 289

Multiple myeloma-lgD (183) - Go to questions 289

Multiple myeloma-lgE (184) - Go to questions 289

Multiple myeloma-lgM (not Waldenstrom macroglobulinemia) (185) - Go to questions 289

Multiple myeloma-light chain only (186) - Go to questions 289

Multiple myeloma-non-secretory (187) - Go to questions 290

Plasma cell leukemia (172) - Go to question 295

Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 295

Amyloidosis (174) - Go to question 295

Osteosclerotic myeloma / POEMS syndrome (176) - Go to questions 295

Light chain deposition disease (177) - Go to questions 295

Other plasma cell disorder (179) - Go to question 288

  1. Specify other plasma cell disorder: _____________________________ - Go to question 295

  2. Light chain

kappa

lambda

  1. 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 questions 291

Stage II (Fitting neither Stage I or Stage III) – Go to questions 291

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 questions 291

Unknown – Go to questions 292

  1. 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)

I.S.S.:

  1. Serum β2-microglobulin: ___ ___ ___ ● ___ ___ ___ μg/dL

mg/L

nmol/L

  1. Serum albumin: ___ ___ ● ___ g/dL

g/L

  1. Stage

1 (β2-mic < 3.5, S. albumin ≥ 3.5)

2 (not fitting stage 1 or 3)

3 (β2-mic ≥ 5.5; S. albumin —)



  1. Were cytogenetics tested (karyotyping or FISH)?

Yes – Go to questions 296

No – Go to question 317

Unknown – Go to question 317

  1. Results of tests:

Abnormalities identified – Go to question 297

No evaluable metaphases – Go to question 317

No abnormalities – Go to question 317

Specify cytogenetic abnormalities identified at any time prior to the start of the preparative regimen:

Trisomy

  1. +3

Yes

No

  1. +5

Yes

No

  1. +7

Yes

No

  1. +9

Yes

No

  1. +11

Yes

No

  1. +15

Yes

No

  1. +19

Yes

No

Translocation

  1. t(4;14)

Yes

No

  1. t(6;14)

Yes

No

  1. t(11;14)

Yes

No

  1. t(14;16)

Yes

No

  1. t(14;20)

Yes

No

Deletion

  1. del (13)/13q-

Yes

No

  1. del (17)/17p-

Yes

No

Other

  1. Hyperdiploid (>50)

Yes

No

  1. Hypodiploid (<46)

Yes

No

  1. Any abnormality at 1q

Yes

No

  1. Any abnormality at 1p

Yes

No

  1. Other abnormality

Yes

No

  1. Specify other abnormality:______________________________________________

Status at transplantation:

  1. What was the disease status?

 Stringent complete remission (sCR). - CR as defined, plus: normal free light chain ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence (confirmation with repeat bone marrow biopsy not needed). (Presence and/or absence of clonal cells is based upon the κ/λ ratio. An abnormal κ/λ ratio by immunohistochemistry and/or immunofluorescence requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting the presence of an abnormal clone is κ/λ of > 4:1 or < 1:2.) sCR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy sCR requirements. - Go to question 318

Complete remission (CR) — negative immunofixation on serum and urine samples, and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in the bone marrow (confirmation with repeat bone marrow biopsy not needed). CR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy CR requirements. - Go to question 318

Near complete remission (nCR) — serum and urine M-protein detectable by immunoelectrophoresis (IFE), but not on electrophoresis (negative SPEP & UPEP); < 5% plasma cells in bone marrow. nCR requires two consecutive assessments made at any time before the initiation of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy nCR requirements. - Go to question 318

 Very good partial remission (VGPR ) — serum and urine M-protein detectable by immunofixation but not on electrophoresis, or 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours. VGPR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy VGPR requirements. - Go to question 318

 Partial remission (PR) 50% reduction in serum M-protein, and reduction in 24-hour urinary M-protein by 90% or to < 200 mg/24 hours. If the serum and urine M-protein are unmeasurable (i.e., do not meet any of the following criteria: • serum M-protein 1 g/dL. Urine M-protein 200 mg/24 hours • serum free light chain assay shows involved level 10 mg/dL, provided serum free light chain ratio is abnormal), a 50% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a 50% reduction in plasma cells is required in place of M-protein, provided the baseline bone marrow plasma cell percentage was 30%. In addition to the above listed criteria, a 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline. PR requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy PR requirements. - Go to question 318

 Stable disease (SD) — not meeting the criteria for CR, VGPR, PR or PD. SD requires two consecutive assessments made at any time before the institution of any new therapy, and no known evidence of progressive or new bone lesions if radiographic studies were performed; radiographic studies are not required to satisfy SD requirements. - Go to question 318

 Progressive disease (PD) — requires any one or more of the following: Increase of 25% from baseline in: serum M-component and/or (absolute increase 0.5 g/dL) (for progressive disease, serum M-component increases of 1 g/dL are sufficient to define relapse if the starting M-component is 5 g/dL). Urine M-component and/or (absolute increase 200 mg/24 hours) for recipients without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase > 10 mg/dL). Bone marrow plasma cell percentage (absolute percentage 10%) (relapse from CR has a 5% cutoff vs. 10% for other categories of relapse) definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in the size of any existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol) that can be attributed solely to the plasma cell proliferative disorder PD requires two consecutive assessments made at any time before classification as disease progression, and/or the institution of any new therapy - Go to question 318

 Relapse from CR (Rel) (untreated) — requires one or more of the following: reappearance of serum or urine M-protein by immunofixation or electrophoresis development of 5% plasma cells in the bone marrow (relapse from CR has a 5% cutoff vs. 10% for other categories of relapse) appearance of any other sign of progression (e.g., new plasmacytoma, lytic bone lesion, hypercalcemia) Rel requires two consecutive assessments made at any time before classification as relapse, and/or the institution of any new therapy. Go to question 318

Unknown – Go to signature line

Not applicable (Amyloidosis with no evidence of myeloma) – Go to signature line

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

YYYY MM DD



Solid Tumors

  1. Specify the solid tumor classification:

Breast cancer (250)

Lung, small cell (202)

 Lung, non-small cell (203)

 Lung, not otherwise specified (230)

 Germ cell tumor, extragonadal (225)

 Testicular (210)

 Ovarian (epithelial) (214)

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

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

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

 Fibrosarcoma (244)

 Hemangiosarcoma (246)

 Leiomyosarcoma (242)

 Liposarcoma (243)

 Lymphangio sarcoma (247)

 Neurogenic sarcoma (248)

 Rhabdomyosarcoma (232)

 Synovial sarcoma (245)

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

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

 Medulloblastoma (226)

 Neuroblastoma (222)

 Head / neck (201)

 Mediastinal neoplasm (204)

 Colorectal (228)

 Gastric (229)

 Pancreatic (206)

 Hepatobiliary (207)

 Prostate (209)

 External genitalia (211)

 Cervical (212)

 Uterine (213)

 Vaginal (215)

 Melanoma (219)

 Wilm tumor (221)

 Retinoblastoma (223)

 Thymoma (231)

 Renal cell (208)

 Other solid tumor (269) – Go to question 320

 Solid tumor, not otherwise specified (200)

  1. Specify other solid tumor: ______________________________- Go to signature line





Severe Aplastic Anemia



  1. Specify the severe aplastic anemia classification:

Acquired severe aplastic anemia, not otherwise specified (301)

Acquired SAA secondary to hepatitis (302)

Acquired SAA secondary to toxin / other drug (303)

Acquired amegakaryocytosis (not congenital) (304)

Acquired pure red cell aplasia (not congenital) (306)

Dyskeratosis congenita (307)

Other acquired cytopenic syndrome (309) – Go to question 322

  1. Specify other acquired cytopenic syndrome: ________________________- Go to signature line



Inherited Abnormalities of Erythrocyte Differentiation or Function

  1. Specify the inherited abnormalities of erythrocyte differentiation or function classification:

Paroxysmal nocturnal hemoglobinuria (PNH) (56)

Shwachman-Diamond (305)

Diamond-Blackfan anemia (pure red cell aplasia) (312)

Other constitutional anemia (319) – Go to question 324

Fanconi anemia (311) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease).

Sickle thalassemia (355)

Sickle cell disease (356)

Beta thalassemia major (357)

Other hemoglobinopathy (359) – Go to question 325

  1. Specify other constitutional anemia: ____________________________________

  2. Specify other hemoglobinopathy:_______________________________

- Go to signature line



Disorders of the Immune System



  1. Specify disorder of immune system classification:

Adenosine deaminase (ADA) deficiency / severe combined immunodeficiency (SCID) (401)

Absence of T and B cells SCID (402)

Absence of T, normal B cell SCID (403)

Omenn syndrome (404)

Reticular dysgenesis (405)

Bare lymphocyte syndrome (406)

Other SCID (419)Go to question 327

SCID, not otherwise specified (410)

Ataxia telangiectasia (451)

HIV infection (452)

DiGeorge anomaly (454)

Common variable immunodeficiency (457)

Leukocyte adhesion deficiencies, including GP180, CD-18, LFA and WBC adhesion deficiencies (459)

Kostmann agranulocytosis (congenital neutropenia) (460)

Neutrophil actin deficiency (461)

Cartilage-hair hypoplasia (462)

CD40 ligand deficiency (464)

Other immunodeficiencies (479) – Go to question 328

Immune deficiency, not otherwise specified (400)

Chediak-Higashi syndrome (456)

 Griscelli syndrome type 2 (465)

Hermansky-Pudlak syndrome type 2 (466)

Chronic granulomatous disease (455)

Wiskott-Aldrich syndrome (453)

X-linked lymphoproliferative syndrome (458)

  1. Specify other SCID: ____________________________- Go to signature line

  2. Specify other immunodeficiency: ____________________________- Go to signature line





Inherited Abnormalities of Platelets



  1. Specify inherited abnormalities of platelets classification:

Congenital amegakaryocytosis / congenital thrombocytopenia (501)

Glanzmann thrombasthenia (502)

Other inherited platelet abnormality (509)Go to question 330

  1. Specify other inherited platelet abnormality: __________________________- Go to signature line



Inherited Disorders of Metabolism

  1. Specify inherited disorders of metabolism classification:

Osteopetrosis (malignant infantile osteopetrosis) (521)

Leukodystrophies

Metachromatic leukodystrophy (MLD) (542)

Adrenoleukodystrophy (ALD) (543)

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 332

Inherited metabolic disorder, not otherwise specified (520)

  1. Specify other inherited metabolic disorder: _______________________________- Go to signature line



Histiocytic disorders

  1. Specify histiocytic disorder classification:

 Hemophagocytic lymphohistiocytosis (HLH) (571)

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

 Hemophagocytosis (reactive or viral associated) (573)

 Malignant histiocytosis (574)

 Other histiocytic disorder (579)Go to question 334

 Histiocytic disorder, not otherwise specified (570)

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



Autoimmune Diseases

  1. 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) Go to question 337

 Other arthritis (633)Go to question 336

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)Go to question 338

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)Go to question 339

Other neurological autoimmune diseases

 Myasthenia gravis (601)

 Other autoimmune neurological disorder (644)Go to question 340

Hematological autoimmune diseases

 Idiopathic thrombocytopenic purpura (ITP) (645)

 Hemolytic anemia (646)

 Evan syndrome (647)

 Other autoimmune cytopenia (648)Go to question 341

Bowel diseases

 Crohn’s disease (649)

 Ulcerative colitis (650)

 Other autoimmune bowel disorder (651)Go to question 342

  1. Specify other arthritis:_________________________________

  2. Specify other juvenile idiopathic arthritis (JIA):_________________________________

  3. Specify other connective tissue disease:_________________________________

  4. Specify other vasculitis:_________________________________

  5. Specify other autoimmune neurological disorder:_________________________________

  6. Specify other autoimmune cytopenia:_________________________________

  7. Specify other autoimmune bowel disorder:_________________________________



- Go to signature line



Other Disease

  1. Specify other disease: _________________________________________



First Name: ____________________________________________________________________________



Last Name:

E-mail address:

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

YYYY MM DD



CIBMTR Form 2402 revision 2 (page 1 of 82) Draft 5/17/2017


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