Proposed Changes to Form

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 paperwork@hrsa.gov.

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 260

• Other leukemia (30) (includes CLL) - Go to question 373

• Hodgkin lymphoma (150) - Go to question 380

• Non-Hodgkin lymphoma (100) - Go to question 380

• Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 398

• Solid tumors (200) - Go to question 446

• Severe aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease) - Go to question 448

• Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 450

• Disorders of the immune system (400) - Go to question 484

• Inherited abnormalities of platelets (500) - Go to question 492

• Inherited disorders of metabolism (520) - Go to question 494

• Histiocytic disorders (570) - Go to question 497

• Autoimmune diseases (600) - Go to question 502

• Tolerance induction associated with solid organ transplant (910) - Go to question 506

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

• Other disease (900) - Go to question 508

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)

4. Did AML transform from MDS or MPN?

• Yes – Also complete MDS Disease Classification questions

• No

5. Is the disease (AML) therapy related?

• Yes

• No

• Unknown

6. Did the recipient have a predisposing condition?

• Yes - Go to question 7

• No - Go to question 9

• Unknown - Go to question 9

7. 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

8. Specify other condition: __________________________________________

Labs at diagnosis

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

• Yes - Go to question 10

• No - Go to question 23

• Unknown - Go to question 23

10. Were cytogenetics tested via FISH?

• Yes – Go to question 11

• No - Go to question 16

11. Results of tests:

• Abnormalities identified – Go to question 12

• No abnormalities - Go to question 16

Specify cytogenetic abnormalities identified at diagnosis:

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

13. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

14. 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

15. Specify other abnormality: _____________________

16. Were cytogenetics tested via karyotyping?

• Yes – Go to question 17

• No - Go to question 22

17. 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:

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

19. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

20. 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

21. Specify other abnormality: _____________________

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

• Yes

• No

23. 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:

24. CEBPA

• Positive – Go to question 25

• Negative - Go to question 26

• Not done - Go to question 26

25. Specify CEBPA mutation

• Biallelic (homozygous)

• Monoallelic (heterozygous)

• Unknown

26. FLT3 – D835 point mutation

• Positive

• Negative

• Not done

27. FLT3 – ITD mutation

• Positive- Go to question 28

• Negative- Go to question 30

• Not done- Go to question 30

28. FLT3 – ITD allelic ratio

• Known - Go to question 29

• Unknown - Go to question 30

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

30. IDH1

• Positive

• Negative

• Not done

31. IDH2

• Positive

• Negative

• Not done

32. KIT

• Positive

• Negative

• Not done

33. NPM1

• Positive

• Negative

• Not done

34. Other molecular marker

• Positive- Go to question 35

• Negative- Go to question 35

• Not done- Go to question 36

35. Specify other molecular marker: _________________________________

Copy and complete questions 34-35 for multiple molecular markers

Labs between diagnosis and last evaluation:

36. 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

37. Were cytogenetics tested via FISH?

• Yes – Go to question 38

• No - Go to question 43

38. Results of tests:

• Abnormalities identified – Go to question 39

• No abnormalities - Go to question 43

Specify cytogenetic abnormalities identified between diagnosis and last evaluation:

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

40. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

41. 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

42. Specify other abnormality: _____________________

43. Were cytogenetics tested via karyotyping?

• Yes – Go to question 44

• No - Go to question 49

44. 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:

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

46. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

47. 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

48. Specify other abnormality: _____________________

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

• Yes

• No

50. 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:

51. CEBPA

• Positive – Go to question 52

• Negative - Go to question 53

• Not done - Go to question 53

52. Specify CEBPA mutation

• Biallelic (homozygous)

• Monoallelic (heterozygous)

• Unknown

53. FLT3 – D835 point mutation

• Positive

• Negative

• Not done

54. FLT3 – ITD mutation

• Positive- Go to question 55

• Negative- Go to question 57

• Not done- Go to question 57

55. FLT3 – ITD allelic ratio

• Known - Go to question 56

• Unknown - Go to question 57

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

57. IDH1

• Positive

• Negative

• Not done

58. IDH2

• Positive

• Negative

• Not done

59. KIT

• Positive

• Negative

• Not done

60. NPM1

• Positive

• Negative

• Not done

61. Other molecular marker:

• Positive- Go to question 62

• Negative- Go to question 62

• Not done- Go to question 63

62. Specify other molecular marker: _________________________________

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

Labs at last evaluation:

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

• Yes - Go to question 64

• No - Go to question 77

• Unknown - Go to question 77

64. Were cytogenetics tested via FISH?

• Yes – Go to question 65

• No - Go to question 70

65. Results of tests:

• Abnormalities identified – Go to question 66

• No abnormalities - Go to question 70

Specify cytogenetic abnormalities identified at last evaluation:

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

67. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

68. 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

69. Specify other abnormality: _____________________

70. Were cytogenetics tested via karyotyping?

• Yes – Go to question 71

• No - Go to question 76

71. 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:

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

73. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

74. 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

75. Specify other abnormality: _____________________

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

• Yes

• No

77. 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:

78. CEBPA

• Positive – Go to question 79

• Negative - Go to question 80

• Not done - Go to question 80

79. Specify CEBPA mutation

• Biallelic (homozygous)

• Monoallelic (heterozygous)

• Unknown

80. FLT3 – D835 point mutation

• Positive

• Negative

• Not done

81. FLT3 – ITD mutation

• Positive- Go to question 82

• Negative- Go to question 84

• Not done- Go to question 84

82. FLT3 – ITD allelic ratio

• Known - Go to question 83

• Unknown - Go to question 84

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

84. IDH1

• Positive

• Negative

• Not done

85. IDH2

• Positive

• Negative

• Not done

86. KIT

• Positive

• Negative

• Not done

87. NPM1

• Positive

• Negative

• Not done

88. Other molecular marker

• Positive- Go to question 89

• Negative- Go to question 89

• Not done- Go to question 90

89. Specify other molecular marker: _________________________________

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

CNS Leukemia

90. 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:

91. 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

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

• 1

• 2

• ≥ 3

93. 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

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

YYYY MM DD

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

YYYY MM DD

Acute Lymphoblastic Leukemia (ALL)

96. 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)

97. Did the recipient have a predisposing condition?

• Yes - Go to question 98

• No - Go to question 100

• Unknown - Go to question 100

98. 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

99. Specify other condition: _________________________________________

100. 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:

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

• Yes - Go to question 102

• No - Go to question 115

• Unknown - Go to question 115

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

• Yes - Go to question 103

• No - Go to question 108

103. Results of tests: (at diagnosis)

• Abnormalities identified - Go to question 104

• No abnormalities - Go to question 108

Specify cytogenetic abnormalities identified at diagnosis:

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

105. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

106. 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

107. Specify other abnormality: _______________________________

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

• Yes - Go to question 109

• No - Go to question 114

109. 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:

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

111. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

112. 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

113. Specify other abnormality: _________________________

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

• Yes

• No

115. 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:

116. BCR / ABL

• Positive

• Negative

• Not done

117. TEL-AML / AML1

• Positive

• Negative

• Not done

118. Other molecular marker

• Positive – Go to question 119

• Negative – Go to question 119

• Not done – Go to question 120

119. Specify other molecular marker: ______________________________

Copy and complete questions 118-119 for additional molecular markers

Laboratory studies between diagnosis and last evaluation:

120. 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

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

• Yes - Go to question 122

• No - Go to question 127

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

• Abnormalities identified - Go to question 123

• No abnormalities - Go to question 127

Specify cytogenetic abnormalities identified between diagnosis and last evaluation:

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

124. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

125. 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

126. Specify other abnormality: ___________________________

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

• Yes - Go to question 128

• No - Go to question 133

128. Results of tests: (between diagnosis and the 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:

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

130. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

131. 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

132. Specify other abnormality: _________________________

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

• Yes

• No

134. 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:

135. BCR / ABL

• Positive

• Negative

• Not done

136. TEL-AML / AML1

• Positive

• Negative

• Not done

137. Other molecular marker

• Positive – Go to question 138

• Negative – Go to question 138

• Not done – Go to question 139

138. Specify other molecular marker: _________________________

Copy and complete questions 137-138 for additional molecular markers

Laboratory studies at last evaluation:

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

• Yes - Go to question 140

• No - Go to question 153

• Unknown - Go to question 153

140. Were cytogenetics tested via FISH?

• Yes - Go to question 141

• No - Go to question 146

141. Results of tests:

• Abnormalities identified - Go to question 142

• No abnormalities - Go to question 146

Specify cytogenetic abnormalities identified at last evaluation:

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

143. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

144. 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

145. Specify other abnormality: ____________________

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

• Yes - Go to question 147

• No - Go to question 152

147. 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:

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

149. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

150. 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

151. Specify other abnormality: ____________________

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

• Yes

• No

153. 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:

154. BCR / ABL

• Positive

• Negative

• Not done

155. TEL-AML / AML1

• Positive

• Negative

• Not done

156. Other molecular marker

• Positive – Go to question 157

• Negative – Go to question 157

• Not done – Go to question 158

157. Specify other molecular marker: ___________________________

Copy and complete questions 156-157 for additional molecular markers

CNS Leukemia

158. 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:

159. 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

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

• 1

• 2

• ≥ 3

161. 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

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

YYYY MM DD

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

YYYY MM DD

Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

164. 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

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

Status at transplantation / infusion:

166. 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

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

YYYY MM DD

Chronic Myelogenous Leukemia (CML)

168. Was therapy given prior to this HCT?

• Yes - Go to question 169

• No - Go to question 175

169. Combination chemotherapy

• Yes

• No

170. Hydroxyurea (Droxia, Hydrea)

• Yes

• No

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

• Yes

• No

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

• Yes

• No

173. Other therapy

• Yes - Go to question 174

• No - Go to question 175

174. Specify other therapy: ______________________________________

175. 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

176. 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)

177. Number

• 1st

• 2nd

• 3rd or higher

178. 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 218

• 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

180. 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

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

• Yes

• No

182. Was the disease MDS therapy related?

• Yes

• No

• Unknown

183. Did the recipient have a predisposing condition?

• Yes – Go to question 184

• No – Go to question 186

• Unknown – Go to question 186

184. 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

185. Specify other condition: _______________________

Laboratory studies at diagnosis of MDS:

186. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

187. WBC

• Known – Go to question 188

• Unknown – Go to question 189

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

 x 10⁶/L

189. Neutrophils

• Known – Go to question 190

• Unknown – Go to question 191

190. ___ ___%

191. Blasts in blood

• Known – Go to question 192

• Unknown– Go to question 193

192. ___ ___ ___ %

193. Hemoglobin

• Known – Go to question 194

• Unknown – Go to question 196

194. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

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

• Yes

• No

196. Platelets

• Known – Go to question 197

• Unknown – Go to question 199

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

 x 10⁶/L

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

• Yes

• No

199. Blasts in bone marrow

• Known – Go to question 200

• Unknown – Go to question 201

200. ___ ___ ___ %

201. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 202

• No – Go to question 218

• Unknown – Go to question 218

202. Were cytogenetics tested via FISH?

• Yes- Go to question 203

• No- Go to question 210

203. Sample source

• Blood

• Bone Marrow

204. Results of tests:

• Abnormalities identified – Go to question 205

• No abnormalities – Go to question 209

Specify cytogenetic abnormalities identified via FISH at diagnosis:

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

206. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

207. 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

208. Specify other abnormality:__________________________

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

• Yes

• No

210. Were cytogenetics tested via karyotyping?

• Yes- Go to question 211

• No- Go to question 218

211. Sample source

• Blood

• Bone marrow

212. 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:

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

214. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

215. 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

216. Specify other abnormality:__________________________

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

• Yes

• No

218. 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

219. 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 blasts02 (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

220. 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

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

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

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

223. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

224. WBC

• Known – Go to question 225

• Unknown – Go to question 226

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

 x 10⁶/L

226. Neutrophils

• Known – Go to question 227

• Unknown – Go to question 228

227. ___ ___%

228. Blasts in blood

• Known – Go to question 229

• Unknown – Go to question 230

229. ___ ___ ___ %

230. Hemoglobin

• Known – Go to question 231

• Unknown – Go to question 233

231. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

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

• Yes

• No

233. Platelets

• Known – Go to question 234

• Unknown – Go to question 226

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

 x 10⁶/L

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

• Yes

• No

236. Blasts in bone marrow

• Known – Go to question 237

• Unknown – Go to question 238

237. ___ ___ ___ %

238. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 239

• No – Go to question 255

• Unknown – Go to question 255

239. Were cytogenetics tested via FISH?

• Yes- Go to question 240

• No- Go to question 246

240. Sample source

• Blood

• Bone Marrow

241. 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:

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

243. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

244. 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

245. Specify other abnormality:__________________________

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

• Yes

• No

247. Were cytogenetics tested via karyotyping?

• Yes- Go to question 248

• No- Go to question 254

248. Sample source

• Blood

• Bone marrow

249. 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:

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

251. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

252. 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

253. Specify other abnormality:__________________________

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

• Yes

• No

Status at transplantation / infusion:

255. What was the disease status?

• Complete remission (CR) –- Go to question 259

• Hematologic improvement (HI) – Go to question 256

• No response (NR) / stable disease (SD) – Go to question 259

• Progression from hematologic improvement (Prog from HI) - Go to question 259

• Relapse from complete remission (Rel from CR) - Go to question 259

• Not assessed - Go to signature line

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

• HI-E –- Go to question 257

• HI-P – Go to question 259

• HI-N – Go to question 259

257. Specify transfusion dependence

• Non transfused (NTD)-– Go to question 259

• Low transfusion burden (LTB)- Go to question 259

• High transfusion burden (HTB)- Go to question 258

258. Specify the response achieved

• Major response

• Minor response

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

YYYY MM DD

Myeloproliferative Neoplasms (MPN)

260. 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 263

• Chronic eosinophilic leukemia, not otherwise specified (NOS) (166) – Go to Question 263

• Essential thrombocythemia (58) – Go to Question 263

• Myeloproliferative neoplasm (MPN), unclassifiable (60) – Go to Question 262

• Myeloid / lymphoid neoplasms with PDGFRA rearrangement (1461) – Go to Question 263

• Myeloid / lymphoid neoplasms with PDGFRB rearrangement (1462) – Go to Question 263

• Myeloid / lymphoid neoplasms with FGFR1 rearrangement (1463) – Go to Question 263

• Myeloid / lymphoid neoplasms with PCM1-JAK2 (1464) – Go to Question 263

• Polycythemia vera (PCV) (57) – Go to Question 263

• Primary myelofibrosis (PMF) (167)- Go to Question 263

Mastocytosis

• Cutaneous mastocytosis (CM) (1465) – Go to Question 263

• Systemic mastocytosis (1470) - Go to Question 261

• Mast cell sarcoma (MCS) (1466) – Go to Question 263

261. Specify Systemic mastocytosis

• Indolent systemic mastocytosis (ISM) – Go to Question 263

• Smoldering systemic mastocytosis (SSM) – Go to Question 263

• Systemic mastocytosis with an associated hematological neoplasm (SM-AHN) – Go to Question 263

• Aggressive systemic mastocytosis (ASM) – Go to Question 263

• Mast cell leukemia (MCL) – Go to Question 263

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

• Yes

• No

Assessment at diagnosis

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

• Yes

• No

• Unknown

Laboratory studies at diagnosis of MPN:

264. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

265. WBC

• Known – Go to question 266

• Unknown – Go to question 267

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

 x 10⁶/L

267. Neutrophils

• Known – Go to question 268

• Unknown – Go to question 269

268. ___ ___%

269. Blasts in blood

• Known – Go to question 270

• Unknown– Go to question 271

270. ___ ___ ___ %

271. Hemoglobin

• Known – Go to question 272

• Unknown – Go to question 274

272. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

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

• Yes

• No

274. Platelets

• Known – Go to question 275

• Unknown – Go to question 277

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

 x 10⁶/L

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

• Yes

• No

277. Blasts in bone marrow

• Known – Go to question 278

• Unknown – Go to question 279

278. ___ ___ ___ %

279. Were tests for driver mutations performed?

• Yes – Go to question 280

• No – Go to question 290

• Unknown - Go to question 290

280. JAK2

• Positive– Go to question 281

• Negative– Go to question 283

• Not done– Go to question 283

281. JAK2 V617F

• Positive

• Negative

• Not done

282. JAK2 Exon 12

• Positive

• Negative

• Not done

283. CALR

• Positive – Go to question 284

• Negative– Go to question 287

• Not done– Go to question 287

284. CALR type 1

• Positive

• Negative

• Not done

285. CALR type 2

• Positive

• Negative

• Not done

286. Not defined

• Positive

• Negative

• Not done

287. MPL

• Positive

• Negative

• Not done

288. CSF3R

• Positive

• Negative

• Not done

289. Was documentation submitted to the CIBMTR?

• Yes

• No

290. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 291

• No – Go to question 307

• Unknown – Go to question 307

291. Were cytogenetics tested via FISH?

• Yes- Go to question 292

• No- Go to question 299

292. Sample source

• Blood

• Bone Marrow

293. Results of tests

• Abnormalities identified – Go to question 294

• No abnormalities – Go to question 298

Specify cytogenetic abnormalities identified via FISH at diagnosis:

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

295. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

296. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(12p11.2;any)

• t(11q23;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 297

297. Specify other abnormality:__________________________

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

• Yes

• No

299. Were cytogenetics tested via karyotyping?

• Yes- Go to question 300

• No- Go to question 307

300. Sample source

• Blood

• Bone marrow

301. Results of tests

• Abnormalities identified – Go to question 302

• No evaluable metaphases- Go to question 306

• No abnormalities – Go to question 306

Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis:

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

303. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

304. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(12p11.2;any)

• t(11q23;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 305

305. Specify other abnormality:__________________________

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

• Yes

• No

307. 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 308

• No – Go to question 311

308. Specify the MPN subtype or AML after transformation

• Post-essential thrombocythemic myelofibrosis– Go to question 309

• Post-polycythemic myelofibrosis– Go to question 309

• Transformed to AML (70) – Go to question 310

309. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 311

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

YYYY MM DD

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

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

• Non-transfused (NTD) -0 RBCs in 16 wk

• Low-transfusion burden (LTB) -(3-7 RBCs in 16 wk in at least 2 transfusion episodes, maximum 3 in 8 wk)

• High-transfusion burden (HTB) - (≥8 RBCs in 16wk, ≥4 in 8 wk)

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

• Yes

• No

• Unknown

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

• Yes – Go to question 314

• No – Go to question 317

• Unknown- Go to question 317

• Not applicable (splenectomy) – Go to question 317

314. Specify the method used to measure spleen size

• Physical assessment- Go to question 315

• Ultrasound- Go to question 316

• CT/ MRI- Go to question 316

315. Specify the spleen size: ___ ___ centimeters below left costal margin

316. Specify the spleen size:___ ___ centimeters

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

• Yes – Go to question 318

• No – Go to question 321

• Unknown – Go to question 321

318. Specify the method used to measure liver size

• Physical assessment- Go to question 319

• Ultrasound- Go to question 320

• CT/ MRI- Go to question 320

319. Specify the liver size: ___ ___ centimeters below right costal margin

320. Specify the liver size: ___ ___ centimeters

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

321. Date CBC drawn: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

322. WBC

• Known – Go to question 323

• Unknown – Go to question 324

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

 x 10⁶/L

324. Neutrophils

• Known – Go to question 325

• Unknown – Go to question 326

325. ___ ___%

326. Blasts in blood

• Known – Go to question 327

• Unknown– Go to question 328

327. ___ ___ ___ %

328. Hemoglobin

• Known – Go to question 329

• Unknown – Go to question 331

329. ___ ___ ___ ___ ● ___ ___  g/dL

3.  g/L

4.  mmol/L

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

• Yes

• No

331. Platelets

• Known – Go to question 332

• Unknown – Go to question 334

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

 x 10⁶/L

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

• Yes

• No

334. Blasts in bone marrow

• Known – Go to question 335

• Unknown – Go to question 336

335. ___ ___ ___ %

336. Were tests for driver mutations performed?

• Yes – Go to question 337

• No – Go to question 347

• Unknown - Go to question 347

337. JAK2

• Positive– Go to question 338

• Negative– Go to question 340

• Not done– Go to question 340

338. JAK2 V6 17F

• Positive

• Negative

• Not Done

339. JAK2 Exon 12

• Positive

• Negative

• Not done

340. CALR

• Positive – Go to question 341

• Negative– Go to question 344

• Not done– Go to question 344

341. CALR type 1

• Positive

• Negative

• Not done

342. CALR type 2

• Positive

• Negative

• Not done

343. Not defined

• Positive

• Negative

• Not done

344. MPL

• Positive

• Negative

• Not done

345. CSF3R

• Positive

• Negative

• Not done

346. Was documentation submitted to the CIBMTR?

• Yes

• No

347. Were cytogenetics tested (karyotyping or FISH)?

• Yes – Go to question 348

• No – Go to question 364

• Unknown – Go to question 364

348. Were cytogenetics tested via FISH?

• Yes- Go to question 349

• No- Go to question 356

349. Sample source

• Blood

• Bone Marrow

350. Results of tests:

• Abnormalities identified – Go to question 351

• No abnormalities – Go to question 355

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

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

352. Specify number of distinct cytogenetic abnormalities:

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

353. Specify abnormalities: (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(12p11.2;any)

• t(11q23;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 354

354. Specify other abnormality:__________________________

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

• Yes

• No

356. Were cytogenetics tested via karyotyping?

• Yes- Go to question 357

• No- Go to question 364

357. Sample source

• Blood

• Bone marrow

358. Results of tests

• Abnormalities identified – Go to question 359

• No evaluable metaphases- Go to question 363

• No abnormalities – Go to question 363

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

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

360. Specify number of distinct cytogenetic abnormalities

• One (1)

• Two (2)

• Three (3)

• Four or more (4 or more)

361. Specify abnormalities (check all that apply)

Monosomy

• –5

• –7

• –Y

Trisomy

• +8

• +9

Translocation

• t(1;any)

• t(3q21;any)

• t(12p11.2;any)

• t(11q23;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 362

362. Specify other abnormality:__________________________

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

• Yes

• No

Status at transplantation / infusion:

364. What was the disease status?

• Complete clinical remission (CR) - Go to question 368

• Partial clinical remission (PR) –- Go to question 368

• Clinical Improvement (CI) - Go to question 365

• Stable disease (SD)- Go to question 368

• Progressive disease - Go to question 368

• Relapse- Go to question 368

• Not assessed - Go to question 369

365. Was an anemia response achieved?

• Yes

• No

366. Was a spleen response achieved?

• Yes

• No

367. Was a symptom response achieved?

• Yes

• No

368. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___- Go to question 369

YYYY MM DD

369. Specify the cytogenetic response

• Complete response (CR): Eradication of previous abnormality – Go to question 370

• Partial response (PR): ≥ 50% reduction in abnormal metaphases – Go to question 370

• Re-emergence of pre-existing cytogenetic abnormality – Go to question 370

• Not assessed – Go to question 371

• Not applicable – Go to question 371

• None of the above: Does not meet the CR or PR criteria – Go to question 370

370. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

371. Specify the molecular response

• Complete response (CR): Eradication of pre-existing abnormality – Go to question 372

• PR: ≥50% decrease in allele burden – Go to question 372

• Re-emergence of a pre-existing molecular abnormality – Go to question 372

• 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 372

372. Date assessed: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

Other Leukemia (OL)

373. Specify the other leukemia classification:

• Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 375

• Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 375

• Hairy cell leukemia (35) - Go to question 378

• Hairy cell leukemia variant (75) - Go to question 378

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

• Prolymphocytic leukemia (PLL), NOS (37) - Go to question 375

• PLL, B-cell (73) - Go to question 375

• PLL, T-cell (74) - Go to question 375

• Other leukemia, NOS (30) - Go to question 377

• Other leukemia (39) - Go to question 374

374. Specify other leukemia: _________________________________– Go to question 377

375. Was any 17p abnormality detected?

• Yes – If disease classification is CLL, go to question 376. If PLL, go to question 378

• No

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

• Yes – Go to question 380– Also complete NHL Disease Classification questions

• No – Go to question 378

Status at transplantation / infusion:

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

• Primary induction failure – Go to question 379

• 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 379

• 2nd complete remission – Go to question 379

• ≥ 3rd complete remission – Go to question 379

• 1st relapse – Go to question 379

• 2nd relapse – Go to question 379

• ≥ 3rd relapse – Go to question 379

• No treatment – Go to signature line

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

• Complete remission (CR) – Go to question 379

• Partial remission (PR) – Go to question 379

• Stable disease (SD) – Go to question 379

• Progressive disease (Prog) – Go to question 379

• Untreated - Go to question 379

• Not assessed - Go to signature line

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

YYYY MM DD

Hodgkin and Non-Hodgkin Lymphoma

380. 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 382

• Diffuse, large B-cell lymphoma- Germinal center B-cell type (1820) - Go to question 382

• 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 381

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 381

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)

381. Specify other lymphoma histology: ______________________– Go to question 383

382. 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

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

• Yes – Go to question 384

• No - Go to question 385

384. Was any 17p abnormality detected?

• Yes– Go to question 389

• No– Go to question 389

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

• Yes – Go to question 386

• No – Go to question 389

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

387. Specify other lymphoma histology:________________

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

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

• Yes – Go to question 390

• No – Go to question 395

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

• Yes

• No

391. Date of PET scan

• Known– Go to question 392

• Unknown – Go to question 393

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

YYYY MM DD

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

• Known – Go to question 394

• Unknown – Go to question 395

394. 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:

395. 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 396

• PIF sen / PR1 - Primary induction failure – sensitive: NEVER in COMPLETE remission but with partial remission on treatment. – Go to question 396

• PIF unk - Primary induction failure – sensitivity unknown– Go to question 396

• CR1 - 1^st complete remission: no bone marrow or extramedullary relapse prior to transplant– Go to question 396

• CR2 - 2^nd complete remission– Go to question 396

• CR3+ - 3^rd or subsequent complete remission– Go to question 396

• REL1 unt - 1^st relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 396

• REL1 res - 1^st relapse – resistant: stable or progressive disease with treatment– Go to question 396

• REL1 sen - 1^st relapse – sensitive: partial remission (if complete remission was achieved, classify as CR2) – Go to question 396

• REL1 unk - 1^st relapse – sensitivity unknown– Go to question 396

• REL2 unt - 2^nd relapse – untreated: includes either bone marrow or extramedullary relapse– Go to question 396

• REL2 res - 2^nd relapse – resistant: stable or progressive disease with treatment– Go to question 396

• REL2 sen - 2^nd relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 396

• REL2 unk - 2^nd relapse – sensitivity unknown– Go to question 396

• REL3+ unt - 3rd or subsequent relapse – untreated; includes either bone marrow or extramedullary relapse– Go to question 396

• REL3+ res - 3^rd or subsequent relapse – resistant: stable or progressive disease with treatment– Go to question 396

• REL3+ sen - 3^rd or subsequent relapse – sensitive: partial remission (if complete remission achieved, classify as CR3+)– Go to question 396

• REL3+ unk - 3^rd relapse or greater – sensitivity unknown– Go to question 396

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

• 1 line

• 2 lines

• 3+ lines

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

YYYY MM DD

Multiple Myeloma / Plasma Cell Disorder (PCD)

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

• Multiple myeloma (178) – Go to question 400

• Multiple myeloma-light chain only (186) - Go to question 400

• Multiple myeloma-non-secretory (187) - Go to question 406

• Plasma cell leukemia (172) - Go to question 408

• Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 405

• Smoldering myeloma (180) – Go to question 408

• Amyloidosis (174) - Go to question 401

• Osteosclerotic myeloma / POEMS syndrome (176) - Go to question 408

• Monoclonal gammopathy of renal significance (MGRS) (1611) – Go to question 402

• Other plasma cell disorder (179) - Go to question 399

399. Specify other plasma cell disorder: _________________________ - Go to question 408

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

• IgG kappa – Go to question 406

• IgA kappa – Go to question 406

• IgM kappa – Go to question 406

• IgD kappa – Go to question 406

• IgE kappa – Go to question 406

• IgG lambda – Go to question 406

• IgA lambda – Go to question 406

• IgM lambda – Go to question 406

• IgD lambda – Go to question 406

• IgE lambda – Go to question 406

• IgG (heavy chain only) – Go to question 406

• IgA (heavy chain only) – Go to question 406

• IgM (heavy chain only) – Go to question 406

• IgD (heavy chain only) – Go to question 406

• IgE (heavy chain only) – Go to question 406

• Kappa (light chain only) – Go to question 406

• Lambda (light chain only) – Go to question 406

401. Specify Amyloidosis classification

• AL amyloidosis – Go to question 408

• AH amyloidosis – Go to question 408

• AHL amyloidosis – Go to question 408

402. Select monoclonal gammopathy of renal significance (MGRS) classification:

• Light chain fanconi syndrome – Go to question 404

• Proximal tubulopathy without crystals – Go to question 404

• Crystal-storing histiocytosis – Go to question 404

• Non-amyloid fibrillary glomerulonephritis – Go to question 404

• Immunotactoid glomerulopathy (ITGN)/ Glomerulonephritis with organized monoclonal microtubular immunoglobulin deposits (GOMMID) – Go to question 404

• Type 1 cryoglobulinemic glomerulonephritis – Go to question 404

• Monoclonal immunoglobulin deposition disease (MIDD) – Go to question 403

• Proliferative glomerulonephritis with monoclonal immunoglobulin G deposits (PGNMID) – Go to question 404

• C3 glomerulopathy with monoclonal gammopathy – Go to question 404

• Unknown – Go to question 404

403. Select monoclonal immunoglobulin deposition disease (MIDD) subtype:

• Light chain deposition disease (LCDD)

• Light and heavy chain deposition disease (LHCDD)

• Heavy chain deposition disease (HCDD)

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

• Yes – Go to question 408

• No – Go to question 408

405. Solitary plasmacytoma was:

• Extramedullary – Go to question 408

• Bone derived – Go to question 408

406. 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 407

• Stage II (Fitting neither Stage I or Stage III) – Go to question 407

• 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 407

• Unknown – Go to question 408

407. 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)

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

• Yes – Go to question 409

• No – Go to question 412

409. Specify preceding / concurrent disorder:

• Multiple myeloma– Go to question 411

• Multiple myeloma-light chain only – Go to question 411

• Multiple myeloma-non-secretory – Go to question 411

• Plasma cell leukemia – Go to question 411

• Solitary plasmacytoma (no evidence of myeloma) – Go to question 411

• Smoldering myeloma – Go to question 411

• Amyloidosis – Go to question 411

• Osteosclerotic myeloma / POEMS syndrome – Go to question 411

• Monoclonal gammopathy of unknown significance (MGUS) – Go to question 411

• Monoclonal gammopathy of renal significance (MGRS) – Go to question 411

• Other plasma cell disorder (PCD) – Go to question 410

410. Specify other preceding/concurrent disorder: ___________________________________

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

YYYY MM DD

Copy questions 409- 411 to report more than one concurrent or preceding disorder.

412. Serum β2-microglobulin:

• Known – Go to question 413

• Unknown – Go to question 414

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

 mg/L

 nmol/L

414. Serum albumin:

• Known – Go to question 415

• Unknown – Go to question 416

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

 g/L

I.S.S. at diagnosis:

416. Stage

• Known – Go to question 417

• Unknown – Go to question 418

417. 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:

418. Stage

• Known – Go to question 419

• Unknown – Go to question 420

419. 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)

420. Plasma cells in blood by flow cytometry

• Known – Go to question 421

• Unknown – Go to question 423

421. ___ ___%

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

□ x 10⁶/L

423. Plasma cells in blood by morphologic assessment

• Known – Go to question 424

• Unknown – Go to question 426

424. ___ ___%

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

□ x 10⁶/L

426. LDH

• Known – Go to question 427

• Unknown – Go to question 429

427. ___ ___ ___ ___ ___ ● ___ ___  U/L

 μkat/L

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

Labs at diagnosis

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

• Yes – Go to question 430

• No – Go to question 442

• Unknown – Go to question 442

430. Were cytogenetics tested via FISH?

• Yes – Go to question 431

• No – Go to question 436

431. Results of tests:

• Abnormalities identified – Go to question 432

• No abnormalities – Go to question 435

Specify cytogenetic abnormalities identified via FISH at diagnosis:

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

433. 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 434

434. Specify other abnormality:_______________________________

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

• Yes

• No

436. Were cytogenetics tested via karyotyping?

• Yes – Go to question 437

• No – Go to question 442

437. Results of tests

• Abnormalities identified – Go to question 438

• No evaluable metaphases – Go to question 441

• No abnormalities – Go to question 441

Specify cytogenetic abnormalities identified via conventional cytogenetics at diagnosis:

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

439. 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 440

440. Specify other abnormality:________________________________

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

• Yes

• No

Status at transplantation / infusion:

442. What was the 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

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

YYYY MM DD

444. 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

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

YYYY MM DD

Solid Tumors

446. 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 447

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

Severe Aplastic Anemia

448. 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 449

449. Specify other acquired cytopenic syndrome: __________________________- Go to signature line

Inherited Abnormalities of Erythrocyte Differentiation or Function

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

• Paroxysmal nocturnal hemoglobinuria (PNH) (56) – Go to signature line

• Shwachman-Diamond (305) – Go to question 453

• Diamond-Blackfan anemia (pure red cell aplasia) (312) – Go to question 453

• Other constitutional anemia (319) – Go to question 451

• Fanconi anemia (311) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease). – Go to question 453

• Sickle thalassemia (355) – Go to question 453

• Sickle cell disease (356) – Go to question 453

• Beta thalassemia major (357) – Go to question 453

• Other hemoglobinopathy (359) – Go to question 452

451. Specify other constitutional anemia: ____________________________________- Go to 453

452. Specify other hemoglobinopathy:_______________________________- Go to 453

453. Did the recipient receive gene therapy to treat the inherited abnormalities of erythrocyte differentiation or function?

• Yes - Also complete Cellular Therapy Product and Infusion forms 4003 and 4006. If sickle cell or sickle thalassemia, go to question 454. If beta thalassemia, go to question 457, else go to signature line

• No - If sickle cell or sickle thalassemia, go to question 454. If beta thalassemia, go to question 457, else go to signature line

454. Was tricuspid regurgitant jet velocity (TRJV) measured by Echocardiography pre-HCT? (sickle cell, sickle thalassemia and beta thalassemia major only)

• Yes – Go to question 455

• No– Go to question 457

• Unknown - Go to question 457

455. TRJV measurement:

• Known – Go to question 456

• Unknown– Go to question 457

456. TRJV measurement: __ __ m/sec

457. Was liver iron content (LIC) tested within 6 months prior to infusion? (sickle cell, sickle thalassemia, beta thalassemia major only)

• Yes – Go to question 458

• No – Go to question 460

458. Liver iron content ___ ___ ___ mg iron / g liver dry weight

459. Method used to estimate LIC?

• T2*MRI

• SQUID MRI

• FerriScan

• Liver biopsy

• Other

Beta thalassemia major

460. Is the recipient red blood cell dependent? (requiring transfusion to maintain HGB >7g/dL)

• Yes – Go to question 461

• No – Go to question 468

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

YYYY

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

• Yes – Go to question 463

• No – Go to question 468

• Unknown – Go to question 468

463. 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 – 466

• No, iron chelation therapy given, but not meeting criteria – Go to question 464

• Iron chelation therapy given, but details of administration unknown – Go to question 466

464. Specify reason criteria not met

• Non-adherence – Go to question 466

• Toxicity due to iron chelation therapy – Go to question 466

• Other – Go to question 465

465. Specify other reason criteria not met: ______________________

466. Year iron chelation therapy started:

• Known – Go to question 467

• Unknown – Go to question 468

467. Year started: ___ ___ ___ ___

YYYY

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

• Yes– Go to question 469

• No– Go to question 470

• Unknown

469. Liver size as measured below the costal margin at most recent evaluation prior to infusion: ___ ___ cm

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

• Yes – Go to questions 471

• No – Go to questions 477

471. Date assessed

• Known – Go to question 472

• Unknown – Go to question 473

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

YYYY MM DD

473. Liver cirrhosis:

• Present

• Absent

• Unknown

474. Bridging fibrosis:

• Present

• Absent

• Unknown

475. Chronic hepatitis:

• Present

• Absent

• Unknown

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

• Yes

• No

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

• Yes

• No

478. Did the recipient have a splenectomy at any time prior to infusion?

• Yes

• No

• Unknown

Laboratory studies at last evaluation prior to start of preparative regimen

479. Serum Iron:

• Known – Go to questions 480

• Unknown – Go to questions 481

480. ___ ___ ___  µg / dL

 µmol / L

481. Total iron binding capacity (TIBC):

• Known – Go to question 482

• Unknown – Go to question 483

482. ___ ___ ___  µg / dL

 µmol / L

483. Was serum bilirubin less than two times the upper limit of normal?

• Yes

• No

• Unknown

Disorders of the Immune System

484. Specify disorder of immune system classification:

• Adenosine deaminase (ADA) deficiency / severe combined immunodeficiency (SCID) (401) – Go to question 487

• Absence of T and B cells SCID (402) – Go to question 487

• Absence of T, normal B cell SCID (403) – Go to question 487

• Omenn syndrome (404) – Go to question 487

• Reticular dysgenesis (405) – Go to question 487

• Bare lymphocyte syndrome (406) – Go to question 487

• Other SCID (419) – Go to question 485

• SCID, not otherwise specified (410) – Go to question 487

• Ataxia telangiectasia (451) – Go to question 487

• HIV infection (452) – Go to question 487

• DiGeorge anomaly (454) – Go to question 487

• Common variable immunodeficiency (457) – Go to question 487

• Leukocyte adhesion deficiencies, including GP180, CD-18, LFA and WBC adhesion deficiencies (459) – Go to question 487

• Kostmann agranulocytosis (congenital neutropenia) (460) – Go to question 487

• Neutrophil actin deficiency (461) – Go to question 487

• Cartilage-hair hypoplasia (462) – Go to question 487

• CD40 ligand deficiency (464) – Go to question 487

• Other immunodeficiencies (479) – Go to question 486

• Immune deficiency, not otherwise specified (400) – Go to question 487

• Chediak-Higashi syndrome (456) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487

• Griscelli syndrome type 2 (465) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487

• Hermansky-Pudlak syndrome type 2 (466) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487

• Other pigmentary dilution disorder (469) – Also complete Pigmentary Dilution Disorder (PDD) Pre-HCT Data Form – Go to question 487

• Chronic granulomatous disease (455) – Go to question 487

• Wiskott-Aldrich syndrome (453) – Go to question 487

• X-linked lymphoproliferative syndrome (458) – Go to question 487

485. Specify other SCID: ____________________________ – Go to question 487

486. Specify other immunodeficiency: ____________________________– Go to question 487

487. Specify other pigmentary dilution disorder: ____________________________– Go to question 487

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

• Yes– Go to question 489

• No– Go to question 490

489. 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)

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

• Yes

• No

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

• Yes

• No

Inherited Abnormalities of Platelets

492. Specify inherited abnormalities of platelets classification:

 Congenital amegakaryocytosis / congenital thrombocytopenia (501)

 Glanzmann thrombasthenia (502)

 Other inherited platelet abnormality (509) – Go to question 493

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

Inherited Disorders of Metabolism

494. Specify inherited disorders of metabolism classification:

• Osteopetrosis (malignant infantile osteopetrosis) (521)

Leukodystrophies

• Metachromatic leukodystrophy (MLD) (542)

• Adrenoleukodystrophy (ALD) (543) – Go to question 496

• 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 495

• Inherited metabolic disorder, not otherwise specified (520)

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

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

Histiocytic disorders

497. Specify histiocytic disorder classification:

 Hemophagocytic lymphohistiocytosis (HLH) (571) – Go to question 499

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

 Hemophagocytosis (reactive or viral associated) (573)

 Malignant histiocytosis (574)

 Other histiocytic disorder (579) – Go to question 498

 Histiocytic disorder, not otherwise specified (570)

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

499. 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 500

• No– Go to question 501

500. 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)

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

• Yes- Go to signature line

• No- Go to signature line

Autoimmune Diseases

502. 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 503

Bowel diseases

• Crohn’s disease (649)

• Ulcerative colitis (650)

• Other autoimmune bowel disorder (651) – Go to question 504

Metabolic

• Diabetes mellitus type 1 (660)

Other

• Other autoimmune disease (629) – Go to question 505

503. Specify other autoimmune cytopenia:_________________________________

504. Specify other autoimmune bowel disorder:_________________________________

505. Specify other autoimmune disease: ____________________

- Go to signature line

Tolerance Induction Associated with Solid Organ Transplant

506. Specify solid organ transplanted: (check all that apply)

• Kidney

• Liver

• Pancreas

• Other organ - Go to question 507

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

Other Disease

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

First Name: ____________________________________________________________________________

Last Name:

E-mail address:

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

YYYY MM DD

CIBMTR Form 2402 revision 5 (page 1 – 101) Draf1 1/15/2020

OMB No: 0915-0310

Expiration Date: 10/31/2022