Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data Key Fields 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: Subsequent Transplant or Cellular Therapy If this is a report of a second or subsequent transplant or cellular therapy for the same disease subtype and this baseline disease insert has t been completed for the previous transplant or cellular therapy (e.g. patient was on TED track for the prior HCT, prior HCT was autologous with consent, prior cellular therapy was t reported to the CIBMTR), begin the form at question one. If this is a report of a second or subsequent transplant or cellular therapy for a different disease, begin the form at question one. Is this the report of a second or subsequent transplant or cellular therapy for the same disease? 1 What was the date of diagsis? - - 2 What was the disease status? (at diagsis) Chronic phase Accelerated phase Blast phase 3 Specify the chronic phase risk score used (at diagsis) EUTOS Hasford Sokal Other Disease Assessment at Diagsis Questions: 1-17 In the treating provider's opinion, specify the risk score: 4 Specify the EUTOS score: 5 Specify the Hasford score: 6 Specify the Sokal score: 7 Specify other chronic phase score: 8 Specify other chronic phase risk score used: 9 Specify blast phase phetype Lymphoid Myeloid Mixed phetype 10 Specify the criteria used to establish accelerated phase or blast phase World Health Organization (WHO) International Bone Marrow Transplant Registry (IBMTR) Sokal MD Anderson European Leukemia Net Other 11 Specify other criteria: 12 Specify the spleen size: centimeters below left lower costal margin 13 Was extramedullary disease present? Specify site(s) of disease: 14 Central nervous system 15 Granulocytic sarcoma Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 1 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 16 Other site 17 Specify other site: Laboratory Studies at Diagsis Questions: 18-83 18 WBC 21 Report findings prior to any first treatment for CML: 19 x 109/L (x 103/mm3) 20 Date sample collected: - - Hemoglobin x 106/L 22 g/dl g/l mmol/l 23 Date sample collected: - - 24 Was RBC transfused 30 days before date of test? 25 Platelets 26 x 109/L (x 103/mm3) x 106/L 27 Date sample collected: - - 28 Were platelets transfused 7 days before date of test? 29 Eosiphils 32 35 38 41 30 % 31 Date sample collected: - - Basophils 33 % 34 Date sample collected: - - Blasts in blood 36 % 37 Date sample collected: - - Blasts in bone marrow 39 % 40 Date sample collected: - - Were cytogenetics tested (karyotyping or FISH)? 42 Were cytogenetics tested via karyotyping? 43 Date sample collected: - - 44 Results of tests Abrmalities identified evaluable metaphases abrmalities Specify cytogenetic abrmalities identified at diagsis: 45 % Ph+ metaphases (t(9;22)(q34;q11) and variants) 46 Other abrmality 47 Specify other abrmality: 48 Was documentation submitted to the CIBMTR? 49 Were cytogenetics tested via FISH? 50 Date sample collected: - - Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 2 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 51 Results of tests Abrmalities identified evaluable metaphases abrmalities 52 % Ph+ metaphases (t(9;22)(q34;q11) and variants) 53 Other abrmality 54 Specify other abrmality: 55 Was documentation submitted to the CIBMTR? 56 Were tests for molecular markers performed (e.g. PCR)? 57 Date sample collected: - - 58 Was BCR / ABL detected? Specify cytogenetic abrmalities identified at diagsis: 59 Specify BCR / ABL breakpoint p190 p210 p230 Other breakpoint 60 Specify other breakpoint: 61 Was BCR / ABL kinase domain mutation analysis performed? 62 T315I 63 WT 64 L248V 65 G250E 66 Q252H 67 Y253F 68 E255K 69 E255V 70 D276G 71 E279K 72 V299L 73 F317L 74 M351T 75 F359V 76 L384M 77 H396P 78 H396R 79 G398R Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 3 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 80 F486S 81 Other mutation 82 Specify other mutation: 83 Was documentation submitted to the CIBMTR? (e.g. pathology report) Pre-HCT or Pre-Infusion Therapy Questions: 84-185 84 Was therapy given? Line of Therapy (1) Questions: 85-185 85 Systemic therapy 86 Date therapy started 88 87 Date started: - - Was therapy stopped? 89 Date therapy stopped 91 90 Date stopped: - - Specify reason therapy stopped 93 Bosutinib (Bosulif) Toxicity t tolerable Lack of response Disease progression Other 92 Specify other reason: 94 Busulfan (Busulfex, Myleran) 95 Corticosteroids 96 Cyclophosphamide (Cytoxan) 97 Cytarabine (Ara-C) 98 Dasatinib (Sprycel) 99 Daurubicin (Cerubidine) 100 Doxorubicin (Adriamycin) 101 Homoharringtonine (HHT) 102 Hydroxyurea (Droxia, Hydrea) 103 Idarubicin (Idamycin) 104 Imatinib (Gleevec) 105 Interferon α (Intron, Roferon) (includes PEG) 106 Methotrexate (MTX) (Amethopterin) 107 Nilotinib (AMN107, Tasigna) 108 Ponatinib (Iclusig) Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 4 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 109 Vincristine (VCR, Oncovin) 110 Other systemic therapy 111 Specify other systemic therapy: 112 Radiation therapy 113 Date therapy started 115 114 Date started: - - Date therapy stopped 117 Spleen 116 Date stopped: - - Specify site(s) of radiation therapy: 118 Other site(s) 119 Specify other site(s): 120 Splenectomy 121 Other therapy 123 WBC 122 Specify other therapy: Therapy response: 124 x 109/L (x 103/mm3) x 106/L 125 Date sample collected: - - 126 Were immature cells (i.e., myelocytes, promyelocytes or myeloblasts) ted on the WBC differential from the peripheral blood? 127 Basophils 128 % 129 Platelets 130 x 109/L (x 103/mm3) x 106/L 131 Date sample collected: - - 132 Were platelets transfused 7 days before date of test? 133 Were cytogenetics tested (karyotyping or FISH)? 134 Were cytogenetics tested via karyotyping? 135 Date sample collected: - - 136 Results of tests Abrmalities identified evaluable metaphases abrmalities Specify cytogenetic abrmalities identified following this line of therapy: 137 % Ph+ metaphases (t(9;22)(q34;q11) and variants) 138 Other abrmality 139 Specify other abrmality: 140 Was documentation submitted to the CIBMTR? Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 5 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 141 Were cytogenetics tested via FISH? 142 Date sample collected: - - 143 Results of tests Abrmalities identified evaluable metaphases abrmalities 144 % Ph+ metaphases (t(9;22)(q34;q11) and variants) 145 Other abrmality 146 Specify other abrmality: 147 Was documentation submitted to the CIBMTR? 148 Were tests for molecular markers performed (e.g. PCR)? 149 Date sample collected: - - 150 Was BCR / ABL detected? Specify cytogenetic abrmalities identified following this line of therapy: 151 Specify level of detection 0.1 % > 0.1 % 3 log reduction from standardized baseline < 3-log reduction from standardized baseline 152 Was BCR/ABL level of detection reported on the standardized International Scale (IS)? 153 Were 2 consecutive tests performed? (quantitative and/or nested; of adequate quality [sensitivity > 10 4 ]) 154 Specify BCR / ABL breakpoint p190 p210 p230 Other breakpoint 155 Specify other breakpoint: 156 Was BCR / ABL kinase domain mutation analysis performed? 157 T315I 158 WT 159 L248V 160 G250E 161 Q252H 162 Y253F 163 E255K 164 E255V 165 D276G 166 E279K 167 V299L 168 F317L Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 6 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 169 M351T 170 F359V 171 L384M 172 H396P 173 H396R 174 G398R 175 F486S 176 Other mutation 177 Specify other mutation: 178 Was documentation submitted to the CIBMTR? (e.g. pathology report) 179 Specify the spleen size: centimeters below left lower costal margin 180 Best response to line of therapy Complete hematologic response (CHR) Chronic phase Accelerated phase Blast phase 181 Specify level of best response cytogenetic response ( CyR) Minimal cytogenetic response Mir cytogenetic response Partial cytogenetic response (PCyR) Complete cytogenetic response (CCyR) Major molecular remission (MMR) Complete molecular remission (CMR) 182 Specify blast phase phetype Lymphoid Myeloid Mixed phetype 183 Date assessed: - - 184 Did disease relapse/progress following this line of therapy? 185 Date of relapse/progression: - - Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion Questions: 186-191 186 Specify the spleen size: centimeters below left lower costal margin 187 Was extramedullary disease present? Specify site(s) of disease: 188 Central nervous system 189 Granulocytic sarcoma 190 Other site 191 Specify other site: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion Questions: 192-252 192 Were immature cells (i.e., myelocytes, promyelocytes or myeloblasts) ted on the WBC differential from the peripheral blood? Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 7 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 193 Eosiphils 196 199 202 205 207 194 % 195 Date sample collected: - - Basophils 197 % 198 Date sample collected: - - Blasts in blood 200 % 201 Date sample collected: - - Blasts in bone marrow 203 % 204 Date sample collected: - - What was the status of bone marrow fibrosis prior to the preparative regimen / infusion? Absent Mild Moderate Severe 206 Date sample collected: - - Were cytogenetics tested (karyotyping or FISH)? 208 Were cytogenetics tested via karyotyping? 209 Date sample collected: - - 210 Results of tests Abrmalities identified evaluable metaphases abrmalities Specify cytogenetic abrmalities identified at last evaluation prior to preparative regimen / infusion: 211 % Ph+ metaphases (t(9;22)(q34;q11) and variants) 212 Other abrmality 213 Specify other abrmality: 214 Was documentation submitted to the CIBMTR? 215 Were cytogenetics tested via FISH? 216 Date sample collected: - - 217 Results of tests Abrmalities identified evaluable metaphases abrmalities 218 % Ph+ metaphases (t(9;22)(q34;q11) and variants) 219 Other abrmality 220 Specify other abrmality: 221 Was documentation submitted to the CIBMTR? 222 Were tests for molecular markers performed (e.g. PCR)? 223 Date sample collected: - - 224 Was BCR / ABL detected? Specify cytogenetic abrmalities identified at last evaluation prior to preparative regimen / infusion: 225 Specify level of detection 0.1 % > 0.1 % 3 log reduction from standardized baseline < 3-log reduction from standardized baseline Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 8 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 226 Was BCR/ABL level of detection reported on the standardized International Scale (IS)? 227 Were 2 consecutive tests performed? (quantitative and/or nested; of adequate quality [sensitivity > 10 4 ]) 228 Specify BCR / ABL breakpoint p190 p210 p230 Other breakpoint 229 Specify other breakpoint: 230 Was BCR / ABL kinase domain mutation analysis performed? 231 T315I 232 WT 233 L248V 234 G250E 235 Q252H 236 Y253F 237 E255K 238 E255V 239 D276G 240 E279K 241 V299L 242 F317L 243 M351T 244 F359V 245 L384M 246 H396P 247 H396R 248 G398R 249 F486S 250 Other mutation 251 Specify other mutation: 252 Was documentation submitted to the CIBMTR? (e.g. pathology report) Disease Status at the Last Evaluation Prior to the Start of the Preparative Regimen / Infusion Questions: 253-256 Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 9 / 10
Form 2012 R3.0: Chronic Myelogeus Leukemia (CML) Pre-Infusion Data 253 What was the disease status? Complete hematologic response (CHR) Chronic phase Accelerated phase Blast phase 254 Specify level of response cytogenetic response ( CyR) Minimal cytogenetic response Mir cytogenetic response Partial cytogenetic response (PCyR) Complete cytogenetic response (CCyR) Major molecular remission (MMR) Complete molecular remission (CMR) 255 Specify blast phase phetype Lymphoid Myeloid Mixed phetype 256 Date assessed: - - First Name: Last Name: E-mail address: Date: - - Copyright(c) 2012 National Marrow Dor Program and The Medical College of Wisconsin, Inc. All rights reserved. Page 10 / 10