Form 2011 R4.0: Acute Lymphoblastic Leukemia (ALL) Pre-HCT Data

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1 Key Fields Sequence Number: Date Received: - - CIBMTR Center Number: CIBMTR Recipient ID: Date of HCT for which this form is being completed: - - 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: Subsequent Transplant Is this the report of a second or subsequent transplant for the same disease? Disease Assessment at Diagsis Questions: What was the date of diagsis? Did the recipient have a predisposing condition? Unkwn 3 Specify condition Aplastic Anemia Also complete CIBMTR Form APL Bloom syndrome Down syndrome Fanconi anemia Also complete CIBMTR Form FAN Neurofibromatosis type 1 Other condition 4 Specify other condition: 5 Was extramedullary disease present? Unkwn Copyright(c) 2012 National Marrow Dor Program and Page 1 / 10

2 Specify site(s) of disease: 6 Central nervous system 7 Mediastinum 8 Testes 9 Other site 10 Specify other site: Laboratory Studies at Diagsis Questions: Report findings prior to any first treatment of the primary disease for which the HCT is being performed. 11 WBC Kwn Unkwn 12 x 10 9 /L (x 10 3 /mm 3 ) x 10 6 /L 13 Date sample collected: Blasts in blood Kwn Unkwn 15 % 16 Date sample collected: Blasts in bone marrow Kwn Unkwn 18 % 19 Date sample collected: Were cytogenetics tested (conventional or FISH)? Unkwn 21 Date sample collected: Results of tests Abrmalities identified No evaluable metaphases No abrmalities 23-7 Specify cytogenetic abrmalities identified at diagsis:mosomy Copyright(c) 2012 National Marrow Dor Program and Page 2 / 10

3 Trisomy Translocation 28 t(1;19) 29 t(2;8) 30 t(4;11) 31 t(5;14) 32 t(8;14) 33 t(8;22) 34 t(9;22) 35 t(10;14) 36 t(11;14) 37 t(12;21) Deletion 38 del(6q) / 6q 39 del(9p) / 9p Copyright(c) 2012 National Marrow Dor Program and Page 3 / 10

4 40 del(12p) / 12p Addition 41 add(14q) Other 42 (11q23) any abrmality 43 9p any abrmality 44 12p any abrmality 45 Hyperdiploid (>50) 46 Hypodiploid (<46) 47 Complex - 3 distinct abrmalities 48 Other abrmality 49 Specify other abrmality: 50 Was documentation submitted to the CIBMTR? (e.g. cytogenetic or FISH report)? 51 Were tests for molecular markers performed (e.g. PCR)? Unkwn 52 Date sample collected: BCR / ABL 54 TEL-AML / AML1 Other Molecular Marker (1) Questions: Other molecular marker 56 Specify other molecular marker: Copyright(c) 2012 National Marrow Dor Program and Page 4 / 10

5 57 Was documentation submitted to the CIBMTR? Pre-HCT Therapy Questions: Was central nervous system prophylaxis given? Unkwn Specify prophylaxis: 59 Cranial irradiation 60 High-dose methotrexate 61 Intrathecal therapy (chemotherapy) 62 Spinal irradiation 63 Other prophylaxis 65 Was therapy given? 64 Specify prophylaxis: Line of Therapy (1) Questions: Line of Therapy: 66 Purpose of therapy Induction Consolidation Maintenance treatment for disease relapse 67 Systemic therapy 68 Date therapy started Kwn Unkwn 69 Date started: Date therapy stopped Kwn Unkwn 71 Date stopped: - - Copyright(c) 2012 National Marrow Dor Program and Page 5 / 10

6 72 Number of cycles Kwn Unkwn 73 Number of cycles: 74 Aldesleukin (interleukin-2, IL-2) 75 Asparaginase 76 Chemotherapy 77 Dasatinib (Sprycel) 78 Imatinib (Gleevec) 79 Interferon-α (Intron, Roferon) (includes PEG) 80 Intrathecal therapy 81 Nilotinib (AMN107, Tasignal) 82 Rituximab (Rituxan, MabThera) 83 Other systemic therapy 85 Radiation therapy 84 Specify other systemic therapy: 86 Date therapy started Kwn Unkwn 87 Date started: Date therapy stopped Kwn Unkwn 89 Date stopped: - - Specify site(s) of radiation therapy: 90 Central nervous system irradiation Copyright(c) 2012 National Marrow Dor Program and Page 6 / 10

7 91 Other site 92 Specify other site: 93 Best response to line of therapy Complete remission (CR) No complete remission - A treatment response where all of the following criteria are met for at least four weeks: < 5% blasts in the bone marrow, rmal maturation of all cellular components in the bone marrow (myeloid, erythroid, and megakaryocytic lineages), extramedullary disease (e.g., central nervous system or soft tissue involvement), ANC of > 1,000/µL, platelets 100,000/µL, transfusion independent 94 Date assessed: Did the recipient relapse following this line of therapy? 96 Date of relapse: Did the recipient have central nervous system leukemia at any time prior to the start of the preparative regimen? Unkwn Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen (Conditioning) Questions: WBC Kwn Unkwn 99 x 10 9 /L (x 10 3 /mm 3 ) x 10 6 /L 100 Date sample collected: Blasts in blood Kwn Unkwn 102 % 103 Date sample collected: Blasts in bone marrow Kwn Unkwn 105 % 106 Date sample collected: Were cytogenetics tested (conventional or FISH)? Unkwn 108 Date sample collected: Results of tests Abrmalities identified No evaluable metaphases No abrmalities Copyright(c) 2012 National Marrow Dor Program and Page 7 / 10

8 110-7 Specify cytogenetic abrmalities identified at last evaluation prior to the start of the preparative regimen:mosomy Trisomy Translocation 115 t(1;19) 116 t(2;8) 117 t(4;11) 118 t(5;14) 119 t(8;14) 120 t(8;22) 121 t(9;22) 122 t(10;14) 123 t(11;14) 124 t(12;21) Deletion 125 del(6q) / 6q Copyright(c) 2012 National Marrow Dor Program and Page 8 / 10

9 126 del(9p) / 9p 127 del(12p) / 12p Addition 128 add(14q) Other 129 (11q23) any abrmality 130 9p any abrmality p any abrmality 132 Hyperdiploid (>50) 133 Hypodiploid (<46) 134 Complex - 3 distinct abrmalities 135 Other abrmality 136 Specify other abrmality: 137 Were tests for molecular markers performed (e.g. PCR)? Unkwn 138 Date sample collected: BCR / ABL 140 TEL-AML / AML1 Other Molecular Marker (1) Questions: Other molecular marker 142 Specify other molecular marker: Copyright(c) 2012 National Marrow Dor Program and Page 9 / 10

10 143 Was flow cytometry performed? Unkwn Specify tissue and results at last evaluation prior to the start of the preparative regimen: 144 Blood 145 Date sample collected: Was disease detected? 147 Bone marrow 148 Date sample collected: Was disease detected? Disease Status at the Last Evaluation Prior to the Preparative Regimen (Conditioning) Questions: What was the disease status (based on hematological test results)? Specify which of the following showed active leukemia at last evaluation prior to the start of the preparative regimen: 151 Blood Unkwn 152 Bone marrow Unkwn 153 Central nervous system Unkwn 154 Testes Unkwn 155 Other site Unkwn 156 Specify other site: 157 Date assessed: - - First Name: Last Name: address: Date: - - Copyright(c) 2012 National Marrow Dor Program and Page 10 / 10

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