Table 1.
Therapy on DFCI ALL Consortium Protocol 95-01
| Type of therapy, duration, and regimen |
|---|
| Induction therapy, 4 wk |
| Vincristine 1.5 mg/m2 intravenously every week for 4 weeks |
| Prednisone 40 mg/m2 by mouth every day for 28 days |
| Doxorubicin 30 mg/m2 intravenously on days 0 and 1* |
| Methotrexate 4 g/m2 intravenously on day 2 |
| Leucovorin 200 mg/m2 intravenous push hour 36, then 24 mg/m2 intravenously every 6 hours until methotrexate level < 0.1 μM |
| Asparaginase 25 000 IU/m2 intramuscularly on day 4† |
| IT-Ara-C at diagnosis, dosed by age‡ |
| ITT on day 16 and 30, dosed by age§ |
| CNS treatment, 3 wk |
| Vincristine 2 mg/m2 intravenously for 1 dose |
| 6-mercaptopurine 50 mg/m2 by mouth for 14 days |
| Doxorubicin 30 mg/m2 intravenously for 1 dose (HR only)* |
| SR: 1800 cGy cranial x-ray therapy (XRT) with IT every 18 weeks vs no XRT and intensive ITT every 9 weeks for 6 doses, then every 18 weeks |
| HR: IT every 18 weeks with 1800 cGy cranial XRT |
| Intensification therapy, 5-6 mo |
| Vincristine 2 mg/m2 intravenously every 3 weeks |
| Prednisone 40 mg/m2 by mouth for 5 days every 3 weeks (SR) |
| Prednisone 120 mg/m2 by mouth for 5 days every 3 weeks (HR) |
| 6-mercaptopurine 50 mg/m2 by mouth for 14 days every 3 weeks |
| Asparaginase every week for 20 doses† |
| Methotrexate 30 mg/m2 intramuscularly every week (SR only) |
| Doxorubicin 30 mg/m2 intravenously every 3 weeks (HR only)* |
| Continuation therapy, 2 y of CCR |
| Vincristine as intensification |
| Prednisone as intensification |
| 6-mercaptopurine as intensification |
| Methotrexate as intensification |
Infants were treated as HR patients but received additional chemotherapy, including high-dose methotrexate and high-dose Ara-C.
HR patients: doxorubicin given with or without dexrazoxane 300 mg/m2. Total cumulative dose of doxorubicin was 300 mg/m2 for HR and 60 mg/m2 for SR patients.
Asparaginase type randomized: E coli or Erwinia each at 25 000 IU/m2 intramuscularly.
IT-Ara-C dosed by age: younger than 1 year, 15 mg; 1-1.99 years, 20 mg; 2-2.99 years, 30 mg; older than 3 years, 40 mg.
ITT: triple intrathecal chemotherapy dosed per age: Ara-C dosing above, younger than 1 year, methotrexate 6 mg and hydrocortisone 6 mg; 1-1.99 years, methotrexate 8 mg and hydrocortisone 9 mg; 2-2.99 years, methotrexate 10 mg and hydrocortisone 12 mg; older than 3 years, methotrexate 12 mg and hydrocortisone 15 mg.