Draft 2402 r1 - Pre-TED Disease (split-track changes)

Pre-Transplant Essential Data:

Disease Classification

^{(Request for OMB approval will be submitted when form is complete)}OMB Placeholder

OMB No: 0915-0310

Expiration Date:

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0310. Public reporting burden for this collection of information is estimated to average 0.85 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland, 20857.

CIBMTR Use Only

Sequence Number:

Date Received:

CIBMTR Center Number: ___ ___ ___ ___ ___

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

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

HCT type: (check all that apply)

 Autologous

 Allogeneic, unrelated

 Allogeneic, related

Product type: (check all that apply)

 Bone marrow

 PBSC

 Single cord blood unit

 Multiple cord blood units

 Other product

Specify:_____________________________________

Primary Disease for HCT

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

YYYY MM DD

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

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

 Acute lymphoblastic leukemia (ALL) (20) - Go to question 64

 Other aAcute leukemia of ambiguous lineage and other myeloid neoplasms (80) - Go to question 107

 Chronic myelogenous leukemia (CML) (40) - Go to question 1121

 Myelodysplastic (MDS) / myeloproliferative (MPN) diseases (50) (Please classify all preleukemias)
(If recipient has transformed to AML, indicate AML as the primary disease) - Go to question 1235

 Other leukemia (30) (includes CLL) - Go to question 2178

 Hodgkin lymphoma (150) - Go to question 2245

 Non-Hodgkin lymphoma (100) - Go to question 2278

 Multiple myeloma / plasma cell disorder (PCD) (170) - Go to question 2334

 Solid tumors (200) - Go to question 2656

 Severe aplastic anemia (300) (If the recipient developed MDS or AML, indicate MDS or AML as the primary disease) - Go to question 2678

 Inherited abnormalities of erythrocyte differentiation or function (310) - Go to question 26970

 Disorders of the immune system (400) - Go to question 2723

 Inherited abnormalities of platelets (500) - Go to question 2756

 Inherited disorders of metabolism (520) - Go to question 2778

 Histiocytic disorders (570) - Go to question 27980

 Autoimmune diseases (600) - Go to question 2812

 Other disease (900) - Go to question 28990

Acute Myelogenous Leukemia (AML)

3. Specify the AML classification:

AML with recurrent genetic abnormalities

 AML with t(9;11) (p22.3;q23.3); MLLT3-KMT2AMLL (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); RPN1-EVI1GATA2, 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 t(15;17)(q22;q12); PML-RARA (283)

AML with BCR-ABL1 (provisional entity)

AML with mutated NPM1

AML with biallelic mutations of CEBPA

AML with mutated RUNX1 (provisional entity)

 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 (t-AML) (9)

AML, not otherwise specified  Myeloid sarcoma (295)

 Blastic plasmacytoid dendritic cell neoplasm (296)

 AML or ANLL, not otherwise specified (280)

 AML, minimally differentiated (M0) (286)

 AML without maturation (M1) (287)

 AML with maturation (M2) (288)

 Acute myelomonocytic leukemia (M4 ) (289)

 Acute monoblastic / acute monocytic leukemia (M5) (290)

 Acute erythroid leukemia (erythroid / myeloid and pure erythroleukemia) (M6) (291)

 Acute megakaryoblastic leukemia (M7) (292)

 Acute basophilic leukemia (293)

 Acute panmyelosis with myelofibrosis (294)

 Myeloid sarcoma (295)

Myeloid leukemia associated with Down syndrome

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 - Go to question 9

 Neurofibromatosis type 1 - Go to question 9

 Other condition - Go to question 8

8. Specify other condition: __________________________________________

9. Were cytogenetics tested (karyotyping or FISH)?

 Yes - Go to question 10

 No - Go to question 47

 Unknown - Go to question 47

10. Results of tests:

 Abnormalities identified – Go to question 11

 No evaluable metaphases - Go to question 47

 No abnormalities - Go to question 47

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

Monosomy

11. –5

Yes

No

12. –7

Yes

No

13. –17

Yes

No

14. –18

Yes

No

15. –X

Yes

No

16. –Y

Yes

No

Trisomy

17. +4

Yes

No

18. +8

Yes

No

19. +11

Yes

No

20. +13

Yes

No

21. +14

Yes

No

22. +21

Yes

No

23. +22

Yes

No

Translocation

24. t(3;3)

Yes

No

25. t(6;9)

Yes

No

26. t(8;21)

Yes

No

27. t(9;11)

Yes

No

28. t(9;22)

Yes

No

29. t(15;17) and variants

Yes

No

30. t(16;16)

Yes

No

Deletion

31. del(3q) / 3q–

Yes

No

32. del(5q) / 5q–

Yes

No

33. del(7q) / 7q–

Yes

No

34. del(9q) / 9q–

Yes

No

35. del(11q) / 11q–

Yes

No

36. del(16q) / 16q–

Yes

No

37. del(17q) / 17q–

Yes

No

38. del(20q) / 20q–

Yes

No

39. del(21q) / 21q–

Yes

No

Inversion

40. inv(3)

Yes

No

41. inv(16)

Yes

No

Other

42. (11q23) any abnormality

Yes

No

43. 12p any abnormality

Yes

No

44. Complex - ≥ 3 distinct abnormalities

Yes

No

45. Other abnormality

Yes - Go to question 46

No - Go to question 47

46. Specify other abnormality: __________________________________

47. Were tests for molecular markers performed (e.g. PCR)?

 Yes – Go to question 48

 No – Go to question 57

 Unknown – Go to question 57

Specify molecular markers identified at any time prior to the start of the preparative regimen:

48. CEBPA

 Positive

 Negative

 Not done

49. FLT3 – D835 point mutation

 Positive

 Negative

 Not done

50. FLT3 – ITD mutation

 Positive

 Negative

 Not done

51. IDH1

 Positive

 Negative

 Not done

52. IDH2

 Positive

 Negative

 Not done

53. KIT

 Positive

 Negative

 Not done

54. NPM1

 Positive

 Negative

 Not done

55. Other molecular marker

 Positive- Go to question 56

 Negative- Go to question 56

 Not done- Go to question 57

56. Specify other molecular marker: _________________________________

Status at transplantation

57. What was the disease status (based on hematologic test results)?

 Primary induction failure – Go to question 63

 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 58

 2nd complete remission – Go to question 58

 ≥ 3rd complete remission – Go to question 58

 1st relapse – Go to question 62

 2nd relapse – Go to question 62

 ≥ 3rd relapse – Go to question 62

 No treatment – Go to question 63

58. How many cycles of induction therapy were required to achieve CR?

1

2

≥ 3

59. Was the recipient in molecular remission?

Yes

No

Unknown

Not applicable

60. Was the recipient in remission by flow cytometry?

Yes

No

Unknown

Not applicable

61. Was the recipient in cytogenetic remission?

Yes – Go to question 63

No – Go to question 63

Unknown – Go to question 63

Not applicable– Go to question 63

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

YYYY MM DD

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

YYYY MM DD

Acute Lymphoblastic Leukemia (ALL)

64. Specify ALL classification:

B-lymphoblastic leukemia / lymphoma

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

 B-lymphoblastic leukemia/lymphoma with t(v;11q23.3); MLL rearrangedKMT2A rearranged (193)

 B-lymphoblastic leukemia/lymphoma with t(1;19)(q23;p13.3); E2A-PBX1TCF3-PBX1 (194)

 B-lymphoblastic leukemia/lymphoma with t(12;21) (p13.2;q22.1); TEL-AML1ETV6-RUNX1 (195)

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

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

 B-lymphoblastic leukemia/lymphoma with Hypodiploidy (<45 chromosomes) (83)

 B-lymphoblastic leukemia/lymphoma with (B-cell ALL, NOS) {L1/L2} (191)

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

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

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

 Early T-cell precursor lymphoblastic leukemia (provisional entity) (#)

Natural killer (NK)- cell lymphoblastic leukemia/lymphoma (provisional entity) (#) ALL, NOS (190)

65. Were tyrosine kinase inhibitors (i.e.imatinib mesylate) given for pre-HCT therapy at any time prior to start of the preparative regimen?

 Yes

 No

66. Were cytogenetics tested (karyotyping or FISH)?

 Yes - Go to question 67

 No - Go to question 95

 Unknown - Go to question 95

67. Results of tests:

 Abnormalities identified – Go to question 68

 No evaluable metaphases - Go to question 95

 No abnormalities - Go to question 95

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

Monosomy

68. –7

 Yes

 No

Trisomy

69. +4

 Yes

 No

70. +8

 Yes

 No

71. +17

 Yes

 No

72. +21

 Yes

 No

Translocation

73. t(1;19)

 Yes

 No

74. t(2;8)

 Yes

 No

75. t(4;11)

 Yes

 No

76. t(5;14)

 Yes

 No

77. t(8;14)

 Yes

 No

78. t(8;22)

 Yes

 No

79. t(9;22)

 Yes

 No

80. t(10;14)

 Yes

 No

81. t(11;14)

 Yes

 No

82. t(12;21)

 Yes

 No

Deletion

83. del(6q) / 6q–

 Yes

 No

84. del(9p) / 9p–

 Yes

 No

85. del(12p) / 12p–

 Yes

 No

Addition

86. add(14q)

 Yes

 No

Other

87. (11q23) any abnormality

 Yes

 No

88. 9p any abnormality

 Yes

 No

89. 12p any abnormality

 Yes

 No

90. Hyperdiploid (> 50)

 Yes

 No

91. Hypodiploid (< 46)

 Yes

 No

92. Complex - ≥3 distinct abnormalities

 Yes

 No

93. Other abnormality

 Yes - Go to question 94

 No - Go to question 95

94. Specify other abnormality: ___________________________

95. Were tests for molecular markers performed (e.g. PCR)?

 Yes – Go to question 96

 No – Go to question 100

 Unknown – Go to question 100

Specify molecular markers identified at any time prior to the start of the preparative regimen:

96. BCR / ABL

 Positive

 Negative

 Not done

97. TEL-AML / AML1

 Positive

 Negative

 Not done

98. Other molecular marker

 Positive – Go to question 99

 Negative – Go to question 99

 Not done – Go to question 100

99. Specify other molecular marker:

Status at Transplantation:

100. What was the disease status (based on hematologic test results)?

 Primary induction failure – Go to question 106

 1st complete remission (no previous marrow or extramedullary relapse) – Go to question 101

 2nd complete remission – Go to question 101

 ≥ 3rd complete remission – Go to question 101

 1st relapse – Go to question 105

 2nd relapse – Go to question 105

 ≥ 3rd relapse – Go to question 105

 No treatment – Go to question 106

101. How many cycles of induction therapy were required to achieve CR?

1

2

≥ 3

102. Was the recipient in molecular remission?

Yes

No

Unknown

Not applicable

103. Was the recipient in remission by flow cytometry?

Yes

No

Unknown

Not applicable

104. Was the recipient in cytogenetic remission?

Yes – Go to question 461106

No – Go to question 461106

Unknown – Go to question 461106

Not applicable – Go to question 461106

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

YYYY MM DD

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

YYYY MM DD

Other Acute Leukemias of Ambiguous Lineage and Other Myeloid Neoplasms

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

 Acute leukemia of ambiguous lineage - Go to question 108

Blastic plasmacytoid dendritic cell neoplasm – Go to question 110

108. Specify acute leukemias of ambiguous lineage classification:

 Acute undifferentiated leukemia (31) - Go to question 109

Mixed phenotype acute leukemia (MPAL) with t(9;22)(q34.1;q11.2); BCR-ABL1

Mixed phenotype acute leukemia with t(v; 11q23.3); KMT2A rearranged

Mixed phenotype acute leukemia, B/myeloid, NOS

Mixed phenotype acute leukemia, T/myeloid, NOS

 Biphenotypic, bilineage or hybrid leukemia (32) - Go to question 109

 Acute mast cell leukemia (33) - Go to question 109

 Other acute leukemia of ambiguous lineage (8#)9) - Go to question 1098

109. Specify other acute leukemia:

Status at Transplantation:

110. What was the disease status (based on hematologic 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

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

YYYY MM DD

Chronic Myelogenous Leukemia (CML)

Philadelphia chromosome+, Ph+, t(9;22)(q34;q11), or variant OR bcr/abl+

112. Specify CML classification:

 Ph+ / bcr+ (41)

 Ph+ / bcr- (42)

 Ph+ / bcr unknown (43)

 Ph- / bcr+ (44)

 Ph unknown / bcr+ (47)

113. Was therapy given prior to this HCT?

 Yes - Go to questions 1133

 No - Go to question 1199

114. Combination chemotherapy

 Yes

 No

115. Hydroxyurea (Droxia, Hydrea)

 Yes

 No

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

 Yes

 No

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

 Yes

 No

118. Other therapy

 Yes - Go to question 118

 No - Go to question 119

119. Specify other therapy: ______________________________________

120. What was the disease statusWhat was the disease status at last evaluation prior to the start of the preparative regimen?

 Complete hematologic responsemission (CHR) - Go to questions 120120

 C First chronic phase – Go to question 124120

 Second or greater chronic phase – Go to question 123

 Accelerated phase - Go to question 1213

 Blast crisis - Go to question 1213

Specify remission:

121. Cytogenetic complete remission (Ph negative)Specify level of response

 No cytogenetic response (No CyR)

 Minimal cytogenetic response

 Minor cytogenetic response

 Partial cytogenetic response (PCyR)

 Major cytogenetic response (MCyR)

 Complete cytogenetic response (CCyR)

 Major molecular remission (MMR)

 Complete molecular remission (CMR) Yes

 No

 Unknown

122. Molecular complete remission (BCR / ABL negative)

 Yes

 No

 Unknown

123. CML disease status before treatment that achieved this CR:

 Chronic phase - Go to question 124

 Accelerated phase - Go to question 124

 Blast phase - Go to question 124

124. Number

 1st

 2nd

 3rd or higher

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

YYYY MM DD

Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases

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

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

 Refractory anemia with ringed sideroblasts (RARS) (55)

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

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

 Refractory cytopenia with multilineage dysplasia (RCMD) (64)

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

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

 Myelodysplastic syndrome (MDS), unclassifiable (50)

 Chronic neutrophilic leukemia (165)

 Chronic eosinophilic leukemia, NOS (166)

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

 Polycythemia vera (PCV) (57)

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

 Myeloproliferative neoplasm (MPN), unclassifiable (60)

 Chronic myelomonocytic leukemia (CMMoL) (54)

 Juvenile myelomonocytic leukemia (JMML/JCML) (no evidence of Ph¹ or BCR/ABL) (36) – Go to question 168525

 Atypical chronic myeloid leukemia, Ph-/bcr/abl- {CML, NOS} (45) - Go to question 577222

 Atypical chronic myeloid leukemia, Ph-/bcr unknown {CML, NOS} (46) - Go to question 577222

 Atypical chronic myeloid leukemia, Ph unknown/bcr- {CML, NOS} (48) - Go to question 577222

 Atypical chronic myeloid leukemia, Ph unknown/bcr unknown {CML, NOS} (49) - Go to question 577222

 Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69)

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

 Yes

 No

 Unknown

128. Did the recipient have a predisposing condition?

 Yes – Go to question 1268

 No – Go to question 12830

 Unknown – Go to question 12830

129. Specify condition:

 Aplastic anemia – Go to question 12830

 Bloom syndrome – Go to question 12830

 Down syndrome – Go to question 12830

 Fanconi anemia – – Go to question 12830

 Other condition – Go to question 1279

130. Specify other condition:

Laboratory Studies at Diagnosis of MDS

131. WBC

 Known

 Unknown

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

 x 10⁶/L

133. Hemoglobin

 Known

 Unknown

134. ___ ___ ___ ___ ● ___ ___  g/dL

 g/L

 mmol/L

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

 Yes

 No

136. Platelets

 Known

 Unknown

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

 x 10⁶/L

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

 Yes

 No

139. Neutrophils

 Known

 Unknown

140. ___ ___%

141. Blasts in bone marrow

 Known

 Unknown

142. ___ ___ ___ %

143. Were cytogenetics tested (karyotyping or FISH)?

 Yes – Go to question 1413

 No – Go to question 16870

 Unknown – Go to question 1687

144. Results of tests:

 Abnormalities identified – Go to question 1424

 No evaluable metaphases – Go to question 16870

 No abnormalities – Go to question 16870

Specify abnormalities identified at diagnosis:

145. Specify number of distinct cytogenetic abnormalities:

 One (1)

 Two (2)

 Three (3)

 Four or more (4 or more)

Monosomy

146. –5

 Yes

 No

147. –7

 Yes

 No

148. –13

 Yes

 No

149. –20

 Yes

 No

150. –Y

 Yes

 No

Trisomy

151. +8

 Yes

 No

152. +19

 Yes

 No

Translocation

153. t(1;3)

 Yes

 No

154. t(2;11)

 Yes

 No

155. t(3;3)

 Yes

 No

156. t(3;21)

 Yes

 No

157. t(6;9)

 Yes

 No

158. t(11;16)

 Yes

 No

Deletion

159. del(3q) / 3q-

 Yes

 No

160. del(5q) / 5q-

 Yes –

 No

161. del(7q) / 7q-

 Yes

 No

162. del(9q) / 9q-

 Yes

 No

163. del(11q) / 11q-

 Yes

 No

164. del(12p) / 12p-

 Yes

 No

165. del(13q) / 13q-

 Yes

 No

166. del(20q) / 20q-

 Yes

 No

Inversion

167. inv(3)

 Yes

 No

Other

168. i17q

 Yes

 No

169. Other abnormality

 Yes – Go to question 1679

 No – Go to question 16870

170. Specify other abnormality:

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

 Yes – Go to question 16971

 No – Go to question 1724

172. Specify the MDS / MPN subtype after transformation:

 Refractory cytopenia with unilineage dysplasia (RCUD) (includes refractory anemia (RA)) (51) – Go to question 1702

 Refractory anemia with ringed sideroblasts (RARS) (55) – Go to question 1702

 Refractory anemia with excess blasts-1 (RAEB-1) (61) – Go to question 1702

 Refractory anemia with excess blasts-2 (RAEB-2) (62) – Go to question 1702

 Refractory cytopenia with multilineage dysplasia (RCMD) (64) – Go to question 1702

 Childhood myelodysplastic syndrome (Refractory cytopenia of childhood (RCC)) (68) – Go to question 1702

 Myelodysplastic syndrome with isolated del(5q) (5q– syndrome) (66) – Go to question 1702

 Myelodysplastic syndrome (MDS), unclassifiable (50) – Go to question 1702

 Chronic neutrophilic leukemia (165) – Go to question 1702

 Chronic eosinophilic leukemia, NOS (166) – Go to question 1702

 Essential thrombocythemia (includes primary thrombocytosis, idiopathic thrombocytosis, hemorrhagic thrombocythemia) (58) – Go to question 1702

 Polycythemia vera (PCV) (57) – Go to question 1702

 Primary myelofibrosis (includes chronic idiopathic myelofibrosis (CIMF), angiogenic myeloid metaplasia (AMM), myelofibrosis/sclerosis with myeloid metaplasia (MMM), idiopathic myelofibrosis) (167) – Go to question 1702

 Myeloproliferative neoplasm (MPN), unclassifiable (60) – Go to question 1702

 Chronic myelomonocytic leukemia (CMMoL) (54) – Go to question 1702

 Myelodysplastic / myeloproliferative neoplasm, unclassifiable (69) – Go to question 1702

 Transformed to AML (70) – Go to question 1713.

173. Specify the date of the most recent transformation:___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 1724

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

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

175. WBC

 Known

 Unknown

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

 x 10⁶/L

177. Hemoglobin

 Known

 Unknown

178. ___ ___ ___ ___ ● ___ ___  g/dL

 g/L

 mmol/L

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

 Yes

 No

180. Platelets

 Known

 Unknown

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

 x 10⁶/L

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

 Yes

 No

183. Neutrophils

 Known

 Unknown

184. ___ ___%

185. Blasts in bone marrow

 Known

 Unknown

186. ___ ___ ___ %

187. Were cytogenetics tested (karyotyping or FISH)?

 Yes – Go to question 1858

 No – Go to question 2125

 Unknown – Go to question 2125

188. Results of tests:

 Abnormalities identified – Go to question 1869

 No evaluable metaphases – Go to question 2125

 No abnormalities – Go to question 2125

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

189. Specify number of distinct cytogenetic abnormalities:

 One (1)

 Two (2)

 Three (3)

 Four or more (4 or more)

Monosomy

190. –5

 Yes

 No

191. –7

 Yes

 No

192. –13

 Yes

 No

193. –20

 Yes

 No

194. –Y

 Yes

 No

Trisomy

195. +8

 Yes

 No

196. +19

 Yes

 No

Translocation

197. t(1;3)

 Yes

 No

198. t(2;11)

 Yes

 No

199. t(3;3)

 Yes

 No

200. t(3;21)

 Yes

 No

201. t(6;9)

 Yes

 No

202. t(11;16)

 Yes

 No

Deletion

203. del(3q) / 3q-

 Yes

 No

204. del(5q) / 5q-

 Yes

 No

205. del(7q) / 7q-

 Yes

 No

206. del(9q) / 9q-

 Yes

 No

207. del(11q) / 11q-

 Yes

 No

208. del(12p) / 12p-

 Yes

 No

209. del(13q) / 13q-

 Yes

 No

210. del(20q) / 20q-

 Yes

 No

Inversion

211. inv(3)

 Yes

 No

Other

212. i17q

 Yes

 No

213. Other abnormality

 Yes – Go to question 2114

 No – Go to question 2125

214. Specify other abnormality:

Status at Transplantation

215. What was the disease status?

 Complete remission (CR) – requires all of the following, maintained for ≥ 4 weeks: * bone marrow evaluation: < 5% myeloblasts with normal maturation of all cell lines * peripheral blood evaluation: hemoglobin ≥ 11 g/dL untransfused and without erythropoietin support; ANC ≥ 1000 / mm 3 without myeloid growth factor support; platlets ≥ 100 x 10⁹/L without thrombopoietic support; 0% blasts - Go to question 2169

 Hematologic improvement (HI) – requires one measurement of the following, maintained for ≥ 8 weeks without ongoing cytotoxic therapy; specify which cell line was measured to determine HI response: * HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks * HI-P – for pre-treatment platelet count of > 20 x 10⁹/L, platelet absolute increase of ≥ 30 x 10⁹/L; for pre-treatment platelet count of < 20 x 10⁹/L, platelet absolute increase of ≥ 20 x 10⁹/L and ≥ 100% from pre-treatment level * HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥ 500 / mm3 - Go to question 2136

 No response (NR) / stable disease (SD) – does not meet the criteria for at least HI, but no evidence of disease progression - Go to question 2169

 Progression from hematologic improvement (Prog from HI) – requires at least one of the following, in the absence of another explanation (e.g., infection, bleeding, ongoing chemotherapy, etc.): * ≥ 50% reduction from maximum response levels in granulocytes or platelets * reduction in hemoglobin by ≥ 1.5 g/dL *transfusion dependence - Go to question 2147

 Relapse from complete remission (Rel from CR) – requires at least one of the following: * return to pre-treatment bone marrow blast percentage * decrease of ≥ 50% from maximum response levels in granulocytes or platelets * transfusion dependence, or hemoglobin level ≥ 1.5 g/dL lower than prior to therapy - Go to question 2158

 Not assessed - Go to signature line

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

 HI-E – hemoglobin increase of ≥ 1.5 g/dL untransfused; for RBC transfusions performed for Hgb ≤ 9.0, reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the pre-treatment transfusion number in 8 weeks - Go to question 2169

 HI-P – for pre-treatment platelet count of > 20 x 10⁹/L, platelet absolute increase of ≥ 30 x 10⁹L; for pre-treatment platelet count of < 20 x 10⁹L, platelet absolute increase of ≥ 20 x 10⁹L and ≥ 100% from pre-treatment level – Go to question 2169

 HI-N – neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of ≥ 500 / mm3 - Go to question 2169

217. Date of progression: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 2169

YYYY MM DD

218. Date of relapse: ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 2169

YYYY MM DD

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

YYYY MM DD

Other Leukemia (OL)

220. Specify the other leukemia classification:

 Chronic lymphocytic leukemia (CLL), NOS (34) - Go to question 575219

 Chronic lymphocytic leukemia (CLL), B-cell / small lymphocytic lymphoma (SLL) (71) - Go to question 575219

 Hairy cell leukemia (35) - Go to question 578221

 Hairy cell leukemia variant (75) - Go to question 578221

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

 Prolymphocytic leukemia (PLL), NOS (37) - Go to question 575219

 PLL, B-cell (73) - Go to question 575219

 PLL, T-cell (74) - Go to question 575219

 Other leukemia, NOS (30) - Go to question 577220

 Other leukemia (39) - Go to question 218574

221. Specify other leukemia: – Go to question 577220

222. Was any 17p abnormality detected?

 Yes – If disease classification is CLL, go to question 2202. If PLL, go to question 2213.

 No

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

 Yes – Go to question 583227– Also complete NHL Disease Classification questions

 No – Go to question 578222

Status at transplantation:

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

 Primary induction failure – Go to question 579223

 1st complete remission (no previous bone marrow or extramedullary relapse) – Go to question 579223

 2nd complete remission – Go to question 579223

 ≥ 3rd complete remission – Go to question 579223

 1st relapse – Go to question 579223

 2nd relapse – Go to question 579223

 ≥ 3rd relapse – Go to question 579223

 No treatment – Go to signature line

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

 Complete remission (CR)

 Partial remission (PR)

 Stable disease (SD)

 Progressive disease (Prog)

 Untreated

 Not assessed - Go to signature line

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

YYYY MM DD

Hodgkin Lymphoma

227. Specify Hodgkin lymphoma classification:

 Nodular lymphocyte predominant Hodgkin lymphoma (155)

 Lymphocyte-rich (151)

 Nodular sclerosis (152)

 Mixed cellularity (153)

 Lymphocyte depleted (154)

 Hodgkin lymphoma, NOS (150)

Status at transplantation:

228. What was the disease status?

Disease untreated

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

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

PIF unk - Primary induction failure – sensitivity unknown

CR1 - 1^st complete remission: no bone marrow or extramedullary relapse prior to transplant

CR2 - 2^nd complete remission

CR3+ - 3^rd or subsequent complete remission

REL1 unt - 1^st relapse – untreated; includes either bone marrow or extramedullary relapse

REL1 res - 1^st relapse – resistant: stable or progressive disease with treatment

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

REL1 unk - 1^st relapse – sensitivity unknown

REL2 unt - 2^nd relapse – untreated: includes either bone marrow or extramedullary relapse

REL2 res - 2^nd relapse – resistant: stable or progressive disease with treatment

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

REL2 unk - 2^nd relapse – sensitivity unknown

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

REL3+ res - 3^rd or subsequent relapse – resistant: stable or progressive disease with treatment

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

REL3+ unk - 3^rd relapse or greater – sensitivity unknown

229. Date assessed: ___ ___ ___ ___ - ___ ___ - ___ ___ - Go to signature line

YYYY MM DD

Non-Hodgkin Lymphoma

230. Specify Non-Hodgkin lymphoma classification:

 Splenic marginal zone B-cell lymphoma (124)

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

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

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

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

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

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

 Follicular (grade unknown) (164)

 Mantle cell lymphoma (115)

 Intravascular large B-cell lymphoma (136)

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

 Primary effusion lymphoma (138)

 Diffuse, large B-cell lymphoma — NOS (107)

 Burkitt lymphoma (111)

 B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma (140)

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

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

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

 Waldenstrom macroglobulinemia / Lymphoplasmacytic lymphoma (173)

 Other B-cell lymphoma (129) – Go to question 584228

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

 Enteropathy-type T-cell lymphoma (133)

 Hepatosplenic T-cell lymphoma (145)

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

 Mycosis fungoides (141)

 Sezary syndrome (142)

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

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

 Angioimmunoblastic T-cell lymphoma (131)

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

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

 T-cell large granular lymphocytic leukemia (126)

 Aggressive NK-cell leukemia (27)

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

 Other T-cell / NK-cell lymphoma (139) – Go to question 584228

231. Specify other lymphoma:

232. Is the non-Hodgkin lymphoma histology reported at diagnosis a transformation from CLL?

 Yes – Go to question 587231- Also complete CLL Disease Classification questions

 No - Go to question 586230

233. Is the non-Hodgkin lymphoma histology reported a transformation from, or was it diagnosed at the same time as another lymphoma (not CLL)?

 Yes

 No

Status at Transplantation

234. What was the disease status?

Disease untreated

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

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

PIF unk - Primary induction failure – sensitivity unknown

CR1 - 1^st complete remission: no bone marrow or extramedullary relapse prior to transplant

CR2 - 2^nd complete remission

CR3+ - 3^rd or subsequent complete remission

REL1 unt - 1^st relapse – untreated; includes either bone marrow or extramedullary relapse

REL1 res - 1^st relapse – resistant: stable or progressive disease with treatment

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

REL1 unk - 1^st relapse – sensitivity unknown

REL2 unt - 2^nd relapse – untreated: includes either bone marrow or extramedullary relapse

REL2 res - 2^nd relapse – resistant: stable or progressive disease with treatment

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

REL2 unk - 2^nd relapse – sensitivity unknown

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

REL3+ res - 3^rd or subsequent relapse – resistant: stable or progressive disease with treatment

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

REL3+ unk - 3^rd relapse or greater – sensitivity unknown

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

YYYY MM DD

Multiple Myeloma / Plasma Cell Disorder (PCD)

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

 Multiple myeloma-lgG (181) - Go to questions 591235

 Multiple myeloma-lgA (182) - Go to questions 235591

 Multiple myeloma-lgD (183) - Go to questions 235591

 Multiple myeloma-lgE (184) - Go to questions 235591

 Multiple myeloma-lgM (not Waldenstrom macroglobulinemia) (185) - Go to questions 235591

 Multiple myeloma-light chain only (186) - Go to questions 235591

 Multiple myeloma-non-secretory (187) - Go to questions 592236

 Plasma cell leukemia (172) - Go to question 597241

 Solitary plasmacytoma (no evidence of myeloma) (175) - Go to question 241597

 Amyloidosis (174) - Go to question 241597

 Osteosclerotic myeloma / POEMS syndrome (176) - Go to questions 241597

 Light chain deposition disease (177) - Go to questions 241597

 Other plasma cell disorder (179) - Go to question 590234

237. Specify other plasma cell disorder: - Go to question 241597

238. Light chain

 kappa

 lambda

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

 Stage I (All of the following: Hgb > 10g/dL; serum calcium normal or <10.5 mg/dL; bone x-ray normal bone structure (scale 0), or solitary bone plasmacytoma only; low M-component production rates IgG < 5g/dL, IgA < 3g/dL; urine light chain M-component on electrophoresis <4g/24h) – Go to questions 593237

 Stage II (Fitting neither Stage I or Stage III) – Go to questions 593237

 Stage III (One of more of the following: Hgb < 8.5 g/dL; serum calcium > 12 mg/dL; advanced lytic bone lesions (scale 3); high M-component production rates IgG >7g/dL, IgA > 5g/dL; Bence Jones protein >12g/24h) – Go to questions 593237

 Unknown – Go to questions 594238

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

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

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

I.S.S.:

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

 mg/L

 nmol/L

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

 g/L

243. Stage

 1 (β₂-mic < 3.5, S. albumin > 3.5)

 2 (β₂-mic 3.5–< 5.5, S. albumin —)

 3 (β₂-mic ≥ 5.5; S. albumin —)

244. Were cytogenetics tested (karyotyping or FISH)?

Yes – Go to questions 598242

No – Go to question 619263

Unknown – Go to question 619 263

245. Results of tests:

Abnormalities identified – Go to question 599243

No evaluable metaphases – Go to question 619263

No abnormalities – Go to question 619263

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

Trisomy

246. +3

Yes

No

247. +5

Yes

No

248. +7

Yes

No

249. +9

Yes

No

250. +11

Yes

No

251. +15

Yes

No

252. +19

Yes

No

Translocation

253. t(4;14)

Yes

No

254. t(6;14)

Yes

No

255. t(11;14)

Yes

No

256. t(14;16)

Yes

No

257. t(14;20)

Yes

No

Deletion

258. del 13/13q-

Yes

No

259. del 17/17p-

Yes

No

Other

260. Hyperdiploid (>50)

Yes

No

261. Hypodiploid (<46)

Yes

No

262. Any abnormality at 1q

Yes

No

263. Any abnormality at 1p

Yes

No

264. Other abnormality

Yes – Go to question 618

No – Go to question 619

265. Specify other abnormality:______________________________________________

Status at transplantation:

266. What was the disease status?

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

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

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

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

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

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

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

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

 Unknown

 Not applicable (Amyloidosis with no evidence of myeloma)

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

YYYY MM DD

Solid Tumors

268. Specify the solid tumor classification:

Breast cancer (250)

Lung, small cell (202)

 Lung, non-small cell (203)

 Lung, not otherwise specified (230)

 Germ cell tumor, extragonadal (225)

 Testicular (210)

 Ovarian (epithelial) (214)

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

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

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

 Fibrosarcoma (244)

 Hemangiosarcoma (246)

 Leiomyosarcoma (242)

 Liposarcoma (243)

 Lymphangio sarcoma (247)

 Neurogenic sarcoma (248)

 Rhabdomyosarcoma (232)

 Synovial sarcoma (245)

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

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

 Medulloblastoma (226)

 Neuroblastoma (222)

 Head / neck (201)

 Mediastinal neoplasm (204)

 Colorectal (228)

 Gastric (229)

 Pancreatic (206)

 Hepatobiliary (207)

 Prostate (209)

 External genitalia (211)

 Cervical (212)

 Uterine (213)

 Vaginal (215)

 Melanoma (219)

 Wilm tumor (221)

 Retinoblastoma (223)

 Thymoma (231)

 Renal cell (208)

 Other solid tumor (269) – Go to question 622266

 Solid tumor, not otherwise specified (200)

269. Specify other solid tumor: ___________________________________

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Severe Aplastic Anemia

270. 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 624268

271. Specify other acquired cytopenic syndrome: _______________________________

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Inherited Abnormalities of Erythrocyte Differentiation or Function

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

 Paroxysmal nocturnal hemoglobinuria (PNH) (56)

 Shwachman-Diamond (305)

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

 Other constitutional anemia (319) – Go to question 626270

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

 Sickle thalassemia (355)

 Sickle cell disease (356)

 Beta thalassemia major (357)

 Other hemoglobinopathy (359) – Go to question 627271

273. Specify other constitutional anemia: ____________________________________

274. Specify other hemoglobinopathy:__________________________________

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Disorders of the Immune System

275. Specify disorder of immune system classification:

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

 Absence of T and B cells SCID (402)

 Absence of T, normal B cell SCID (403)

 Omenn syndrome (404)

 Reticular dysgenesis (405)

 Bare lymphocyte syndrome (406)

 Other SCID (419) – Go to question 629273

 SCID, not otherwise specified (410)

 Ataxia telangiectasia (451)

 HIV infection (452)

 DiGeorge anomaly (454)

 Common variable immunodeficiency (457)

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

 Kostmann agranulocytosis (congenital neutropenia) (460)

 Neutrophil actin deficiency (461)

 Cartilage-hair hypoplasia (462)

 CD40 ligand deficiency (464)

 Other immunodeficiencies (479) – Go to question 630274

 Immune deficiency, not otherwise specified (400)

 Chediak-Higashi syndrome (456)

 Griscelli syndrome type 2 (465)

 Hermansky-Pudlak syndrome type 2 (466)

 Chronic granulomatous disease (455)

 Wiskott-Aldrich syndrome (453)

 X-linked lymphoproliferative syndrome (458)

276. Specify other SCID: ____________________________

277. Specify other immunodeficiency: ____________________________

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Inherited Abnormalities of Platelets

278. Specify inherited abnormalities of platelets classification:

 Congenital amegakaryocytosis / congenital thrombocytopenia (501)

 Glanzmann thrombasthenia (502)

 Other inherited platelet abnormality (509) – Go to question 277276

279. Specify other inherited platelet abnormality: ___________________________________

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Inherited Disorders of Metabolism

280. Specify inherited disorders of metabolism classification:

 Osteopetrosis (malignant infantile osteopetrosis) (521)

Leukodystrophies

 Metachromatic leukodystrophy (MLD) (542)

 Adrenoleukodystrophy (ALD) (543)

 Krabbe disease (globoid leukodystrophy) (544)

 Lesch-Nyhan (HGPRT deficiency) (522)

 Neuronal ceroid lipofuscinosis (Batten disease) (523)

Mucopolysaccharidoses

 Hurler syndrome (IH) (531)

 Scheie syndrome (IS) (532)

 Hunter syndrome (II) (533)

 Sanfilippo (III) (534)

 Morquio (IV) (535)

 Maroteaux-Lamy (VI) (536)

 β-glucuronidase deficiency (VII) (537)

 Mucopolysaccharidosis (V) (538)

 Mucopolysaccharidosis, not otherwise specified (530)

Mucolipidoses

 Gaucher disease (541)

 Niemann-Pick disease (545)

 I-cell disease (546)

 Wolman disease (547)

 Glucose storage disease (548)

 Mucolipidoses, not otherwise specified (540)

Polysaccharide hydrolase abnormalities

 Aspartyl glucosaminidase (561)

 Fucosidosis (562)

 Mannosidosis (563)

 Polysaccharide hydrolase abnormality, not otherwise specified (560)

 Other inherited metabolic disorder (529) – Go to question 634278

 Inherited metabolic disorder, not otherwise specified (520)

281. Specify other inherited metabolic disorder: ___________________________________

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Histiocytic disorders

282. Specify histiocytic disorder classification:

 Hemophagocytic lymphohistiocytosis (HLH) (571)

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

 Hemophagocytosis (reactive or viral associated) (573)

 Malignant histiocytosis (574)

 Other histiocytic disorder (579) – Go to question 636280

 Histiocytic disorder, not otherwise specified (570)

283. Specify other histiocytic disorder: ________________________________________

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Autoimmune Diseases

284. Specify autoimmune disease classification:

Arthritis

 Rheumatoid arthritis (603)

 Psoriatic arthritis / psoriasis (604)

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

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

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

 Juvenile idiopathic arthritis (JIA): other (643) Go to question 638282

 Other arthritis (633) – Go to question 639283

Multiple sclerosis

 Multiple sclerosis (602)

Connective tissue diseases

 Systemic sclerosis (scleroderma) (607)

 Systemic lupus erythematosis (SLE) (605)

 Sjögren syndrome (608)

 Polymyositis / dermatomyositis (606)

 Antiphospholipid syndrome (614)

 Other connective tissue disease (634) – Go to question 640284

Vasculitis

 Wegener granulomatosis (610)

 Classical polyarteritis nodosa (631)

 Microscopic polyarteritis nodosa (632)

 Churg-Strauss (635)

 Giant cell arteritis (636)

 Takayasu (637)

 Behcet syndrome (638)

 Overlap necrotizing arteritis (639)

 Other vasculitis (611) – Go to question 641285

Other neurological autoimmune diseases

 Myasthenia gravis (601)

 Other autoimmune neurological disorder (644) – Go to question 642286

Hematological autoimmune diseases

 Idiopathic thrombocytopenic purpura (ITP) (645)

 Hemolytic anemia (646)

 Evan syndrome (647)

 Other autoimmune cytopenia (648) – Go to question 643287

Bowel diseases

 Crohn’s disease (649)

 Ulcerative colitis (650)

 Other autoimmune bowel disorder (651) – Go to question 644288

285. Specify other arthritis:_________________________________

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

287. Specify other connective tissue disease:_________________________________

288. Specify other vasculitis:_________________________________

289. Specify other autoimmune neurological disorder:_________________________________

290. Specify other autoimmune cytopenia:_________________________________

291. Specify other autoimmune bowel disorder:_________________________________

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Other Disease

292. Specify other disease: _________________________________________

First Name: ____________________________________________________________________________

Last Name:

E-mail address:

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

YYYY MM DD

CIBMTR Form 2402 revision 1 (page 1 of 60) Draft 104/2819/2016