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Table 1 FRALLE 93 protocol schedule for very high risk patients

From: Impact of age, leukocyte count and day 21-bone marrow response to chemotherapy on the long-term outcome of children with philadelphia chromosome-positive acute lymphoblastic leukemia in the pre-imatinib era: results of the FRALLE 93 study

Phase Treatment Dose
Induction Vincristine 1.5 mg/m2 IV (max, 2 mg) on D8, D15, D22, D29
  Prednisone 60 mg/m2/d PO on D1–8, 40 mg/m2/d on D8–28
  Daunorubicin§ 40 mg/m2 IV on D8, D9, D10, D15
  L-Asparaginase§ 10,000 U/m2 IM or IV on D20, D22, D24, D26, D29, D31, D33, D35
  intrathecal therapy* before D4, D8, and D15
R3 course Cytarabine 2 g/m2 IV bid on D1–D2
  Etoposide 150 mg/m2 IV on D3, D4, D5
  Dexamethasone 20 mg/m2 PO on D2–D5
  intrathecal therapy* D5
COPADM course Vincristine 1.5 mg/m2 (max, 2 mg) IV on D1
  Methotrexate 8000 mg/m2 (24-hour IV infusion with leucovorin rescue) on D1
  Doxorubicin 60 mg/m2 IV on D2
  Cyclophosphamide 375 mg/m2 bid on D2–D3
  Prednisone 60 mg/m2 PO on D1–D5
Stem-cell transplantation age >4 years: TBI 2 Gy bid on D-9 to D-7
  age <4 years: Busulfan 30 mg/m2/6 hours PO on D-10 to D-7
  All patients: Cytarabine 3 g/m2 bid on D-5 to D-4
  Melphalan 140 mg/m2IV on D-2
  Transplantation IV day 0
Maintenance after autologous transplantation 6-mercaptopurine Vincristine 75 mg/m2/d 2 years after complete remission 1.5 mg/m2 monthly for 12 months
  1. Abbreviations: PO, per os; IV, intravenous; IM, intramuscular; max, maximum; TBI, total body irradiation
  2. §before July 1996: daunorubicin on D8, D15, and D22 and L-Asparaginase on D22, D24, D26, D29, D31, D33.
  3. *Methotrexate, Cytarabine, and Depomedrol in doses based on patient age
  4. Other post-induction regimen: no R3 or COPADM but 1 consolidation, 2 intensifications, and an interim phase over 36 weeks before 18 months of maintenance therapy