Table 2.
Therapy on DFCI ALL Consortium Protocols: 1985–2000
| Induction (4 weeks) | vincristine 1.5 mg/m2 q week (maximum=2 mg) (days 0, 7, 14, 21) |
| prednisone 40 mg/m2/day (days 0–28) | |
| doxorubicin 30 mg/m2/dose (days 0 and 1) | |
| Protocol 95-01: randomized +/− dexrazoxane 300 mg/m2 (HR only) | |
| Methotrexate × 1 dose (day 2): dose per protocol | |
| Protocol 85-01: 40 mg/m2 | |
| Protocol 87-01: 40 mg/m2 or 4 gram/m2 with leucovorin (randomized) | |
| Protocols 91-01 + 95-01: 4 gram/m2 with leucovorin | |
| Asparaginase | |
| Protocol 85-01: E.coli ASP × 1 dose (investigational window; 5 days pre-day 0) | |
| Protocol 87-01: E. coli, Erwinia or PEG ASP × 1 dose (randomized; investigational window; 5days pre-day 0) | |
| Protocol 91-01: None | |
| Protocols 95-01: E.coli or Erwinia ASP 25,000 IU/m2 × 1 dose (randomized; day 4) | |
| IT cytarabine* × 1 dose (day 0), IT chemotherapy day 14 | |
| CNS therapy (3 weeks) | vincristine 2.0 mg/m2 IV day 1 (maximum=2 mg) |
| 6MP 50 mg/m2/day orally days 1–15 | |
| HR only: doxorubicin 30 mg/m2 on day 1 | |
| Protocol 95-01: randomized +/− dexrazoxane 300 mg/m2 | |
| IT chemotherapy twice weekly × 4 doses | |
| Cranial Radiation per protocol (beginning day 1) | |
| Protocol 85-01: SR-18Gy; HR-24 Gy | |
| Protocol 87-01: SR-No XRT; HR-18 Gy | |
| Protocol 91-01: SR girls-No XRT; SR boys and HR-18 Gy. | |
| Protocol 95-01: SR: randomized-No XRT versus 18 Gy; HR-18 Gy | |
|
Intensification (20–30 weeks) |
Every 3 week cycles: |
| SR: vincristine 2.0 mg/m2 IV day 1 (maximum=2 mg) | |
| prednisone 40 mg/m2/day orally days 1–5 | |
| Protocol 91-01: dexamethasone 6 mg/m2/day instead of prednisone | |
| methotrexate 30 mg/m2 IV or IM days 1, 8, 15 | |
| 6MP 50 mg/m2/day orally days 1–15 | |
| Protocol 91-01: Randomized oral 6MP vs IV 6MP 1000 mg/m2 on days 1 and 8 of each cycle for first 12 months of treatment | |
| Asparaginase IM according to protocol: | |
| Protocols 85-01 + 87-01: E.coli ASP 25,000 IU/m2 weekly | |
| Protocol 91-01 (randomized): E.coli ASP 25,000 IU/m2 weekly or PEG ASP 2500 IU/m2 every 2-weeks | |
| Protocol 95-01 (randomized): E.coli ASP 25,000 IU/m2 weekly or Erwinia ASP 25000 IU/m2 weekly | |
| IT chemotherapy per text | |
| HR: same as SR patients, except prednisone dose higher (120 mg/m2/day 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 | |
| Protocol 91-01: dexamethasone 18 mg/m2/day instead of prednisone | |
| Protocol 95-01: doxorubicin +/− dexrazoxane 300 mg/m2 (randomized) | |
|
Continuation (until 24 months CCR) |
Every 3 week cycles: |
| SR: same as intensification, except no asparaginase | |
| HR: same as SR patients | |
| IT chemotherapy per text | |
Abbreviations: IT intrathecal, SR standard risk, HR high risk, 6MP: 6-mercaptopurine, IV: intravenous, IM: intramuscular, CCR= continuous complete remission
*
IT cytarabine dosed according to age.(6) Patients with CNS leukemia at diagnoses (CNS-2 and CNS-3) received twice weekly doses of IT cytarabine until CSF was clear of blasts cells on three consecutive examinations.