34
CIBMTR Form 2057 revision 1 (page 1 of 34). Form released May, 2020. Last Updated May, 2020. Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved. Myeloproliferative Neoplasms (MPN) Pre-Infusion Data Registry Use Only Sequence Number: Date Received: CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Event date: __ __ __ __ / __ __ / __ __ YYYY MM DD Preview only

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Page 1: Registry Use Only Preview only€¦ · ☐ MF - 1: Loose network of reticulin with many intersections, especially in perivascular areas ☐ MF - 2: Diffuse and dense increase in reticulin

CIBMTR Form 2057 revision 1 (page 1 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Myeloproliferative Neoplasms (MPN) Pre-Infusion Data

Registry Use OnlySequence Number:

Date Received:

CIBMTR Center Number: ___ ___ ___ ___ ___

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

Event date: __ __ __ __ / __ __ / __ __YYYY MM DD

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

1. Is this the report of a second or subsequent transplant or cellular therapy for the same disease?

☐ Yes - Go to question 41

☐ No - Go to question 2

2. Specify transfusion dependence at diagnosis

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

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

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

3. Did the recipient have splenomegaly at diagnosis?

☐ Yes

☐ No

☐ Unknown

☐ Not applicable (splenectomy)

7. Did the recipient have hepatomegaly at diagnosis?

☐ Yes

☐ No

☐ Unknown

4. Specify the method used to measure spleen size

☐ Physical assessment

☐ Ultrasound

☐ CT/ MRI

8. Specify the method used to measure liver size

☐ Physical assessment

☐ Ultrasound

☐ CT/ MRI

CIBMTR Form 2057 revision 1 (page 2 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Subsequent Transplant or Cellular Therapy

Disease Assessment at Diagnosis

5. Specify the spleen size:

___ ___ centimeters below left costal margin

6. Specify the spleen size: ___ ___ centimeters

9. Specify the liver size:

___ ___ centimeters below right costal margin

10. Specify the liver size: ___ ___ centimeters

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Report findings prior to any first treatment of the primary disease for which the HCT / cellular therapy is being performed.

11. DateCBCwithdifferentialdrawn:________/____/____ YYYY MM DD

12. Neutrophils

☐ Known

☐ Unknown

14. Bands

☐ Known

☐ Unknown

16. Metamyelocytes

☐ Known

☐ Unknown

18. Myelocytes

☐ Known

☐ Unknown

20. Lymphocytes

☐ Known

☐ Unknown

22. Monocytes

☐ Known

☐ Unknown

24. Basophils

☐ Known

☐ Unknown

26. Eosinophils

☐ Known

☐ Unknown

28. Was a bone marrow examination performed?

☐ Yes

☐ No

☐ Unknown

CIBMTR Form 2057 revision 1 (page 3 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Diagnostic Studies (Measured Prior to Any Disease Treatment)

13. ___ ___%

15. ___ ___%

17. ___ ___%

19. ___ ___%

21. ___ ___%

23. ___ ___%

25. ___ ___%

27. ___ ___%

29. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

30. Cellularity

☐ Decreased (hypocellular)

☐ Normal (normocellular)

☐ Increased (hypercellular)

☐ Unknown

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

33. Were molecular tests for molecular markers performed? (e.g. PCR) (please do not include driver mutations JAK2, CALR, MPL, and CSF3R as previously captured on the Disease Classification F2402)

☐ Yes

☐ No

☐ Unknown

34. Indicate if a positive molecular marker(s) was identified

☐ Yes

☐ No

CIBMTR Form 2057 revision 1 (page 4 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

31. Myelofibrosis grading by WHO classification

☐ Known

☐ Unknown

35. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

36. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

32. Specify the Grade

☐ MF - 0: Scattered linear reticulin with no intersection (crossovers) corresponding to normal BM

☐ MF - 1: Loose network of reticulin with many intersections, especially in perivascular areas

☐ MF - 2: Diffuse and dense increase in reticulin with extensive intersections, occasionally with focal bundles of thick fibers mostly consistent with collagen, and/or focal osteosclerosis

☐ MF - 3: Diffuse and dense increase in reticulin with extensive intersections and coarse bundles of thick fibers consistent with collagen, usually associated with osteosclerosis

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 5 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

40. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

Copy questions 36 - 39 to report more than one gene mutation

37. Specify other molecular marker:___________________________

38. Amino acid change

☐ Known

☐ Unknown 39. p. ______________________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

41. Specify the maximum DIPSS score the patient ever achieved: ___

42. Specify when maximum DIPSS score was documented

☐ At diagnosis - Go to question 55

☐ Between diagnosis and the preparative regimen - Go to question 43

☐ At last evaluation prior to the start of the preparative regimen - Go to question 55

Report the clinical and laboratory assessments used to determine the maximum DIPSS score

43. Date CBC drawn: __ __ __ __ / __ __ / __ __ YYYY MM DD

44. WBC

☐ Known

☐ Unknown

46. Blasts in blood

☐ Known

☐ Unknown

48. Hemoglobin

☐ Known

☐ Unknown

51. Platelets

☐ Known

☐ Unknown

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

☐ Yes ☐ No ☐ Unknown

CIBMTR Form 2057 revision 1 (page 6 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

DIPSS Prognosis Score

45. ___ ___ ___ ___ ___ ___ • ___ ☐ x 109/L (x 103/mm3) ☐ x 106/L

47. ___ ___ ___ %

49. ___ ___ ___ ___ • ___ ___ ☐ g/dL ☐ g/L ☐ mmol/L

50. WereRBCstransfused≤30daysbeforedateoftest?

☐ Yes ☐ No

52. ___ ___ ___ ___ ___ ___ ___ ☐ x 109/L (x 103/mm3) ☐ x 106/L

53. Wereplateletstransfused≤7daysbeforedateoftest?

☐ Yes ☐ No

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

55. Was therapy given?

☐ Yes

☐ NoSpecify laboratory findings immediately prior to this line of therapy 56. Date CBC with differential drawn: __ __ __ __ / __ __ / __ __ YYYY MM DD

57. WBC

☐ Known

☐ Unknown

59. Neutrophils

☐ Known

☐ Unknown

61. Bands

☐ Known

☐ Unknown

63. Metamyelocytes

☐ Known

☐ Unknown

65. Myelocytes

☐ Known

☐ Unknown

67. Lymphocytes

☐ Known

☐ Unknown

69. Monocytes

☐ Known

☐ Unknown

71. Basophils

☐ Known

☐ Unknown

73. Eosinophils

☐ Known

☐ Unknown

CIBMTR Form 2057 revision 1 (page 7 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Pre-HCT / Pre-Infusion Therapy

58. ___ ___ ___ ___ ___ ___ • ___ ☐ x 109/L (x 103/mm3)

☐ x 106/L

60. ___ ___%

62. ___ ___%

64. ___ ___%

66. ___ ___%

68. ___ ___%

70. ___ ___%

72. ___ ___%

74. ___ ___%

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

75. Blasts in blood

☐ Known

☐ Unknown

77. Hemoglobin

☐ Known

☐ Unknown

80. Platelets

☐ Known

☐ Unknown

83. Blasts in bone marrow

☐ Known

☐ Unknown

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

☐ Yes ☐ No ☐ Unknown

87. Were tests for driver mutations performed?

☐ Yes ☐ No ☐ Unknown

CIBMTR Form 2057 revision 1 (page 8 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

76. ___ ___ ___ %

84. ___ ___ ___ %

85. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

78. ___ ___ ___ ___ • ___ ___ ☐ g/dL ☐ g/L ☐ mmol/L

79. WereRBCstransfused≤30daysbeforedateoftest?

☐ Yes ☐ No

81. ___ ___ ___ ___ ___ ___ ___ ☐ x 109/L (x 103/mm3) ☐ x 106/L

82. Wereplateletstransfused≤7daysbeforedateoftest?

☐ Yes ☐ No

88. JAK2

☐ Positive

☐ Negative

☐ Not done

89. JAK2 V617F

☐ Positive

☐ Negative

☐ Not done

90. JAK2 Exon 12

☐ Positive

☐ Negative

☐ Not done Preview

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

98. Were molecular tests for molecular markers performed? (e.g. PCR) (please do not include driver mutations JAK2, CALR, MPL, and CSF3R as previously captured above)

☐ Yes ☐ No ☐ Unknown

99. Indicate if a positive molecular marker(s) was identified

☐ Yes ☐ No

CIBMTR Form 2057 revision 1 (page 9 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

91. CALR

☐ Positive

☐ Negative

☐ Not done

95. MPL ☐ Positive ☐ Negative ☐ Not done

96. CSF3R ☐ Positive ☐ Negative ☐ Not done

97. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No

100. Specify the total number of positive molecular markers: ___ ___

101. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

92. CALR type 1

☐ Positive

☐ Negative

☐ Not done

93. CALR type 2

☐ Positive

☐ Negative

☐ Not done

94. Not defined

☐ Positive

☐ Negative

☐ Not done

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 10 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

102. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

103. Specify other molecular marker:

________________________________

104. Amino acid change

☐ Known

☐ Unknown

105. p. ______________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 11 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

106. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

107. Specify other molecular marker:

________________________________

108. Amino acid change

☐ Known

☐ Unknown

109. p. ______________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 12 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

110. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

111. Specify other molecular marker:

________________________________

112. Amino acid change

☐ Known

☐ Unknown

113. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 13 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

114. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

115. Specify other molecular marker:

________________________________

116. Amino acid change

☐ Known

☐ Unknown

117. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 14 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

118. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

119. Specify other molecular marker:

________________________________

120. Amino acid change

☐ Known

☐ Unknown

121. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 15 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

122. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

123. Specify other molecular marker:

________________________________

124. Amino acid change

☐ Known

☐ Unknown

125. p. _______________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 16 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

126. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

127. Specify other molecular marker:

________________________________

128. Amino acid change

☐ Known

☐ Unknown

129. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 17 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

130. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

131. Specify other molecular marker:

________________________________

132. Amino acid change

☐ Known

☐ Unknown

133. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 18 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

134. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

135. Specify other molecular marker:

________________________________

136. Amino acid change

☐ Known

☐ Unknown

137. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 19 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

138. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

139. Specify other molecular marker:

________________________________

140. Amino acid change

☐ Known

☐ Unknown

141. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 20 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

142. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

143. Specify other molecular marker:

________________________________

144. Amino acid change

☐ Known

☐ Unknown

145. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 21 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

146. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

147. Specify other molecular marker:

________________________________

148. Amino acid change

☐ Known

☐ Unknown

149. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 22 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

150. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

151. Specify other molecular marker:

________________________________

152. Amino acid change

☐ Known

☐ Unknown

153. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 23 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

154. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

155. Specify other molecular marker:

________________________________

156. Amino acid change

☐ Known

☐ Unknown

157. p. _____________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 24 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

158. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

159. Specify other molecular marker:

________________________________

160. Amino acid change

☐ Known

☐ Unknown

161. p. ______________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 25 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

163. Were cytogenetics tested? (karyotyping or FISH)

☐ Yes

☐ No

☐ Unknown

162. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No

164. Were cytogenetics tested via FISH?

☐ Yes

☐ No 165. Sample source ☐ Blood ☐ Bone Marrow

166. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

167. Results of tests

☐Abnormalitiesidentified

☐ No abnormalities

Specify cytogenetic abnormalities identified via FISH prior to this line of therapy

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

________________________________

169. Specify number of distinct cytogenetic abnormalities

☐ One (1)

☐ Two (2)

☐ Three (3)

☐ Four or more (4 or more)

170. 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)

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 26 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

173. Were cytogenetics tested via karyotyping?

☐ Yes

☐ No

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

☐ Yes ☐ No

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

171. Specify other abnormality:

_______________________

174. Sample source ☐ Blood ☐ Bone Marrow

175. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

176. Results of tests

☐Abnormalitiesidentified

☐ No evaluable metaphases

☐ No abnormalities

Specify cytogenetic abnormalities identified via conventional cytogenetics prior to this line of therapy

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

________________________________Prev

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 27 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

178. Specify number of distinct cytogenetic abnormalities

☐ One (1)

☐ Two (2)

☐ Three (3)

☐ Four or more (4 or more)

179. 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

180. Specify other abnormality:

_______________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

CIBMTR Form 2057 revision 1 (page 28 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Line of Therapy

182. Systemic therapy

☐ Yes

☐ No

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

☐ Yes ☐ No

183. Date therapy started

☐ Known

☐ Unknown

185. Date therapy stopped

☐ Known

☐ Unknown

187. Specify the reason therapy stopped

☐ Toxicity (e.g. cytopenia)

☐ Not tolerable

☐ Lack of response

☐ Disease progression

☐ Response (treatment achieved goal)

☐ Other

☐ Unknown

189. Specify systemic drugs given (check all drugs given as part of this line of therapy)

☐ Androgen

☐ Azacytidine (Vidaza)

☐ Corticosteroids

☐ Cytarabine (Ara-C)

☐ Decitabine (Dacogen)

☐ Fedratinib (Inrebic)

☐ Hydroxyurea (Droxia, Hydrea)

☐ Idarubicin (Idamycin)

☐ Lenalidomide (Revlimid)

☐Ruxolitinib(Jakafi)

☐ Thalidomide (Thalomid)

☐ Tyrosine kinase inhibitor (TKI) (e.g. imatinib mesylate)

☐ Venetoclax

☐ Other JAK1 or JAK2 inhibitor - Go to question 190

☐ Other systemic therapy - Go to question 191

184. Date started: __ __ __ __ / __ __ / __ __ YYYY MM DD

186. Date stopped: __ __ __ __ / __ __ / __ __ YYYY MM DD

188. Specify other reason: ___________________________________

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

192. Supportive Treatment

☐ Yes

☐ No

194. Cellular therapy (e.g. CAR-T cells) ☐ Yes ☐ No

195. Blinded randomized trial

☐ Yes

☐ No

197. Splenic radiation ☐ Yes ☐ No

198. Splenectomy

☐ Yes

☐ No

200. Other therapy

☐ Yes

☐ No

202. Best response to line of therapy

☐ Complete clinical remission (CR) - Go to question 206

☐ Partial clinical remission (PR) - Go to question 206

☐ Clinical Improvement (CI) - Go to question 203

☐ Stable disease (SD) - Go to question 206

☐ Progressive disease - Go to question 206

☐ Relapse - Go to question 206

☐ Progression to AML (AML) - Go to question 206

☐ Not assessed - Go to question 207

CIBMTR Form 2057 revision 1 (page 29 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

190. Specify other JAK1 or JAK2 inhibitor:_______________________

191. Specify other systemic therapy: ___________________________

193. Specify supportive treatment given (check all that apply)

☐ Deferiprone (Ferriprox)

☐ Deferasirox (Exjade)

☐ Deferoxamine (Desferal)

☐ Erythropoietin (EPO) (any formulation)

☐ G-CSF (any formulation)

☐ Thrombopoietin analog

196. Specify the ClinicalTrials.gov identification number: NCT ___ ___ ___ ___ ___ ___ ___ ___

199. Specify the date the splenectomy was performed: __ __ __ __ / __ __ / __ __ YYYY MM DD

201. Specify other therapy: _______________________________________________________

203. Was an anemia response achieved? ☐ Yes ☐ No

204. Was a spleen response achieved? ☐ Yes ☐ No

205. Was a symptom response achieved? ☐ Yes ☐ No

206. Date assessed: __ __ __ __ / __ __ / __ __ YYYY MM DD

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

207. Specify the best cytogenetic response to line of therapy

☐ Complete response (CR): Eradication of pre-existing abnormality - Go to question 208

☐ Partial response (PR): ≥ 50% reduction in abnormal metaphases - Go to question 208

☐ Re-emergence of pre-existing cytogenetic abnormality - Go to question 208

☐ Not assessed - Go to question 209

☐ Not applicable - Go to question 209

☐ None of the above (Does not meet the CR or PR criteria) - Go to question 208

209. Specify the best molecular response to line of therapy

☐ Complete response (CR): Eradication of pre-existing abnormality - Go to question 210

☐ Partial response (PR): ≥50% decrease in allele burden - Go to question 210

☐ Re-emergence of pre-existing molecular abnormality - Go to question 210

☐ Not assessed - Go to question 211

☐ Not applicable - Go to question 211

☐ None of the above (Does not meet the CR or PR criteria) - Go to question 210

211. Did disease relapse/progress following this line of therapy?

☐ Yes

☐ No

Copy questions 56 - 212 if needed for multiple lines of therapy

CIBMTR Form 2057 revision 1 (page 30 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

208. Date assessed: __ __ __ __ / __ __ / __ __ YYYY MM DD

210. Date assessed: __ __ __ __ / __ __ / __ __ YYYY MM DD

212. Date of relapse/progression: __ __ __ __ / __ __ / __ __ YYYY MM DD

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

213.DateCBCwithdifferentialdrawn:________/____/____ YYYY MM DD

214. Neutrophils

☐ Known

☐ Unknown

216. Bands

☐ Known

☐ Unknown

218. Metamyelocytes

☐ Known

☐ Unknown

220. Myelocytes

☐ Known

☐ Unknown

222. Monocytes

☐ Known

☐ Unknown

224. Basophils

☐ Known

☐ Unknown

226. Eosinophils

☐ Known

☐ Unknown

228. Was a bone marrow examination performed?

☐ Yes

☐ No

☐ Unknown

CIBMTR Form 2057 revision 1 (page 31 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

215. ___ ___%

217. ___ ___%

219. ___ ___%

221. ___ ___%

223. ___ ___%

225. ___ ___%

227. ___ ___%

229. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

230. Cellularity

☐ Decreased (hypocellular)

☐ Normal (normocellular)

☐ Increased (hypercellular)

☐ UnknownPreview

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

233. Were molecular tests for molecular markers performed? (e.g. PCR) (please do not include driver mutations JAK2, CALR, MPL, and CSF3R as previously captured on the Disease Classification F2402)

☐ Yes

☐ No

☐ Unknown

CIBMTR Form 2057 revision 1 (page 32 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

231. Myelofibrosis grading by WHO classification

☐ Known

☐ Unknown232. Specify the Grade

☐ MF - 0: Scattered linear reticulin with no intersection (crossovers) corresponding to normal BM

☐ MF - 1: Loose network of reticulin with many intersections, especially in perivascular areas

☐ MF - 2: Diffuse and dense increase in reticulin with extensive intersections, occasionally with focal bundles of thick fibers mostly consistent with collagen, and/or focal osteosclerosis

☐ MF - 3: Diffuse and dense increase in reticulin with extensive intersections and coarse bundles of thick fibers consistent with collagen, usually associated with osteosclerosis

234. Indicate if a positive molecular marker(s) was identified

☐ Yes

☐ No235. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

236. Specify the positive molecular marker

☐ ASXL1

☐ BCOR

☐ BCORL1

☐ CBL

☐ CUX1

☐ DNMT3A

☐ ETV6

☐ EZH2

☐ FLT3

☐ GATA2

☐ IDH1

☐ IDH2

☐ IKZF1

☐ KRAS

☐ LNK

☐ NF1

☐ NPM1

☐ NRAS

☐ PHF6

☐ PPM1D

☐ PTPN11

☐ P53 (TP53)

☐ RUNX1

☐ SETBP1

☐ SF3B1

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

241.Wasflowcytometryperformed?

☐ Yes

☐ No

☐ Unknown

250. Total serum ferritin

☐ Known ☐ Unknown

253. CD34+ cells (peripheral blood)

☐ Known ☐ Unknown

Specify tissue and results

242. Blood

☐ Yes

☐ No

246. Bone marrow

☐ Yes

☐ No

251.__________________ng/mL(μg/L)

252. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

254. ___ ___ ___ ___ • ___ ___ x 10 ___ ___

243. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

244. Was disease detected?

☐ Yes

☐ No

247. Date sample collected: __ __ __ __ / __ __ / __ __ YYYY MM DD

248. Was disease detected?

☐ Yes

☐ No

240. Was documentation submitted to the CIBMTR? ☐ Yes ☐ No

☐ SRSF2

☐ STAG2

☐ TET2

☐ U2AF1

☐ WT1

☐ ZRSR2

☐ Other molecular marker

Copy questions 236 - 239 to report more than one gene mutation

237. Specify other molecular marker:___________________________

238. Amino acid change

☐ Known

☐ Unknown

245. Specify percent disease detected: ___ ___ • ___ ___ ___ %

249. Specify percent disease detected: ___ ___ • ___ ___ ___ %

239. p. _____________________________

CIBMTR Form 2057 revision 1 (page 33 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

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CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

255. Did the recipient have pulmonary hypertension at HCT / infusion? ☐ Yes ☐ No ☐ Unknown

256. Did the recipient have portal hypertension at HCT / infusion? ☐ Yes ☐ No ☐ Unknown

257. Iron overload

☐ Yes

☐ No

First Name: _____________________________________________________________

Last Name: ______________________________________________________________

E-mail address: __________________________________________________________

Date: __ __ __ __ / __ __ / __ __ YYYY MM DD

CIBMTR Form 2057 revision 1 (page 34 of 34). Form released May, 2020. Last Updated May, 2020.Copyright (c) 2020 National Marrow Donor Program and The Medical College of Wisconsin, Inc. All rights reserved.

Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

258. Indicate how the iron overload diagnosis was made

☐ Serum ferritin

☐ Liver MRI

☐ T2*MRI

☐ SQUID MRI

☐ Liver biopsy

☐ FerriScan

☐ Other method

Specify therapy given for iron overload

260. Iron chelation therapy ☐ Yes ☐ No

261. Phlebotomy ☐ Yes ☐ No

259. Specify other method: __________________

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