Therapy on DFCI ALL Consortium Protocol 95-01
| Time frame . | Treatment . |
|---|---|
| Induction, 4 wk | Vincristine 1.5 mg/m2 every week (maximum, 2 mg), days 0, 7, 14, 21 |
| Prednisone 40 mg/m2/d, days 0-28 | |
| Doxorubicin 30 mg/m2/dose, days 0 and 1 | |
| HR: randomized with/without dexrazoxane 300 mg/m2, days 0 and 1 | |
| Methotrexate 4 g/m2 (8-24 h after doxorubicin) with leucovorin rescue | |
| Asparaginase (randomized Erwinia or E coli) 25 000 IU/m2 IM × 1 dose, day 4 | |
| IT cytarabine* × 1 dose, day 0 | |
| TIT† × 1 dose, day 16 | |
| CNS therapy, 3 wk | SR: Randomized: TIT only (see “Randomizations”) or 18-Gy hyperfractionated cranial radiation with IT methotrexate/cytarabine |
| HR: 18-Gy cranial radiation (randomized hyperfractionated or daily fractions) with IT methotrexate/cytarabine | |
| Intensification, 30 wk | Every 3 wk cycles: |
| SR: Vincristine 2.0 mg/m2 IV day 1 (maximum, 2 mg) | |
| Prednisone 40 mg/m2/d orally, days 1-5 | |
| Methotrexate 30 mg/m2 IV or IM, days 1, 8, 15 | |
| 6-MP 50 mg/m2/d orally, days 1-15 | |
| Asparaginase (randomized): Erwinia 25 000 IU/m2 IM weekly × 20 wk | |
| or | |
| E coli 25 000 IU/m2 IM weekly × 20 weeks | |
| HR: same as SR patients, except prednisone dose higher (120 mg/m2/d orally days 1-5), no methotrexate, doxorubicin 30 mg/m2 day 1 of each cycle (cumulative dose of 300 mg/m2), randomized to be given alone or with dexrazoxane 300 mg/m2/dose | |
| Continuation, until 24 mo CCR | Every 3 week cycles: |
| SR: same as intensification, except no asparaginase | |
| HR: same as SR patients, except dose of prednisone (120 mg/m2/d, days 1–5) |
| Time frame . | Treatment . |
|---|---|
| Induction, 4 wk | Vincristine 1.5 mg/m2 every week (maximum, 2 mg), days 0, 7, 14, 21 |
| Prednisone 40 mg/m2/d, days 0-28 | |
| Doxorubicin 30 mg/m2/dose, days 0 and 1 | |
| HR: randomized with/without dexrazoxane 300 mg/m2, days 0 and 1 | |
| Methotrexate 4 g/m2 (8-24 h after doxorubicin) with leucovorin rescue | |
| Asparaginase (randomized Erwinia or E coli) 25 000 IU/m2 IM × 1 dose, day 4 | |
| IT cytarabine* × 1 dose, day 0 | |
| TIT† × 1 dose, day 16 | |
| CNS therapy, 3 wk | SR: Randomized: TIT only (see “Randomizations”) or 18-Gy hyperfractionated cranial radiation with IT methotrexate/cytarabine |
| HR: 18-Gy cranial radiation (randomized hyperfractionated or daily fractions) with IT methotrexate/cytarabine | |
| Intensification, 30 wk | Every 3 wk cycles: |
| SR: Vincristine 2.0 mg/m2 IV day 1 (maximum, 2 mg) | |
| Prednisone 40 mg/m2/d orally, days 1-5 | |
| Methotrexate 30 mg/m2 IV or IM, days 1, 8, 15 | |
| 6-MP 50 mg/m2/d orally, days 1-15 | |
| Asparaginase (randomized): Erwinia 25 000 IU/m2 IM weekly × 20 wk | |
| or | |
| E coli 25 000 IU/m2 IM weekly × 20 weeks | |
| HR: same as SR patients, except prednisone dose higher (120 mg/m2/d orally days 1-5), no methotrexate, doxorubicin 30 mg/m2 day 1 of each cycle (cumulative dose of 300 mg/m2), randomized to be given alone or with dexrazoxane 300 mg/m2/dose | |
| Continuation, until 24 mo CCR | Every 3 week cycles: |
| SR: same as intensification, except no asparaginase | |
| HR: same as SR patients, except dose of prednisone (120 mg/m2/d, days 1–5) |
IM indicates intramuscular: IT, intrathecal; TIT, triple intrathecal chemotherapy (methotrexate, cytarabine, hydrocortisone): IV, intravenous; 6-MP: 6-mercaptopurine.
IT cytarabine dosed according to age.1 Patients with CNS leukemia at diagnosis (CNS-2 and CNS-3) received twice-weekly doses of IT cytarabine until CSF was clear of blast cells on 3 consecutive examinations. †TIT dosage according to age.1