Therapy on DFCI ALL Consortium Protocol 91-01
| Phase of therapy (time period) . | Therapy . |
|---|---|
| Investigational window (3 d) | Steroid × 3 d (randomized): prednisone (40 mg/m2/d) or dexamethasone (6, 18, or 150 mg/m2/d) |
| IT cytarabine* (dosage by age × 1 dose, d 0) | |
| Induction | Vincristine (1.5 mg/m2/wk; maximum, 2 mg) |
| (4 wk) | Prednisone (40 mg/m2/d) |
| Doxorubicin (30 mg/m2 per dose; d 1 and 2) | |
| Methotrexate (4 gm/m2, 8-24 h after doxorubicin) with leucovorin rescue | |
| IT cytarabine* (dosage by age × 1 dose, d 17) | |
| CNS therapy (3 wk) | SR girls: IT methotrexate†/cytarabine* (× 4 doses for 2 wk, then q 18 wk) |
| SR boys and all HR patients: cranial XRT 1800 cGy (randomized): hyperfractionated (90 cGy bid) or conventional (180 cGy qd) with IT methotrexate/cytarabine (dosage as in SR patients) | |
| Intensification | q 3-wk cycles |
| (30 wk) | SR: vincristine (2.0 mg/m2 IV q 3 wk; maximum, 2 mg) |
| dexamethasone (6 mg/m2/d PO × 5 d) | |
| methotrexate (30 mg/m2 IV or IM q wk) | |
| 6-MP (randomized): | |
| high-dose: 1000 mg/m2 IV for 20 h, wk 1 and 2 or conventional: 50 mg/m2/d PO × 14 days | |
| asparaginase (randomized): | |
| PEG 2500 IU/m2 IM q 2 wk × 15 doses or E coli 25 000 IU/m2 IM q wk × 30 doses | |
| HR: same as SR patients, except: | |
| dexamethasone dose (18 mg/m2/d PO × 5 d) | |
| no methotrexate | |
| doxorubicin (30 mg/m2 q 3 wk; cumulative dose, 360 mg/m2) (randomized): | |
| continuous infusion for 48 h or IV bolus | |
| Continuation | q 3-wk cycles |
| (until 2 y CCR) | SR: same as intensification, except no asparaginase; all 6-MP given via conventional dose (50 mg/m2/d × 14 d) |
| HR: same as SR patients, except dexamethasone dose (as above) |
| Phase of therapy (time period) . | Therapy . |
|---|---|
| Investigational window (3 d) | Steroid × 3 d (randomized): prednisone (40 mg/m2/d) or dexamethasone (6, 18, or 150 mg/m2/d) |
| IT cytarabine* (dosage by age × 1 dose, d 0) | |
| Induction | Vincristine (1.5 mg/m2/wk; maximum, 2 mg) |
| (4 wk) | Prednisone (40 mg/m2/d) |
| Doxorubicin (30 mg/m2 per dose; d 1 and 2) | |
| Methotrexate (4 gm/m2, 8-24 h after doxorubicin) with leucovorin rescue | |
| IT cytarabine* (dosage by age × 1 dose, d 17) | |
| CNS therapy (3 wk) | SR girls: IT methotrexate†/cytarabine* (× 4 doses for 2 wk, then q 18 wk) |
| SR boys and all HR patients: cranial XRT 1800 cGy (randomized): hyperfractionated (90 cGy bid) or conventional (180 cGy qd) with IT methotrexate/cytarabine (dosage as in SR patients) | |
| Intensification | q 3-wk cycles |
| (30 wk) | SR: vincristine (2.0 mg/m2 IV q 3 wk; maximum, 2 mg) |
| dexamethasone (6 mg/m2/d PO × 5 d) | |
| methotrexate (30 mg/m2 IV or IM q wk) | |
| 6-MP (randomized): | |
| high-dose: 1000 mg/m2 IV for 20 h, wk 1 and 2 or conventional: 50 mg/m2/d PO × 14 days | |
| asparaginase (randomized): | |
| PEG 2500 IU/m2 IM q 2 wk × 15 doses or E coli 25 000 IU/m2 IM q wk × 30 doses | |
| HR: same as SR patients, except: | |
| dexamethasone dose (18 mg/m2/d PO × 5 d) | |
| no methotrexate | |
| doxorubicin (30 mg/m2 q 3 wk; cumulative dose, 360 mg/m2) (randomized): | |
| continuous infusion for 48 h or IV bolus | |
| Continuation | q 3-wk cycles |
| (until 2 y CCR) | SR: same as intensification, except no asparaginase; all 6-MP given via conventional dose (50 mg/m2/d × 14 d) |
| HR: same as SR patients, except dexamethasone dose (as above) |
In the table, d indicates day; IT, intrathecal; wk, week; h, hour; SR, standard risk; HR, high risk; CCR, continuous complete remission; IM, intramuscularly; IV, intravenously; q, every (quaue); bid, twice a day (bis in die); qd, every day (quaque die); and XRT, radiation therapy.
Indicates IT cytarabine dosage per age: less than one year: 15 mg; at least 1 year, but less than 2 years: 20 mg; at least 2 years, but less than 3 years: 30 mg; and at least 3 years: 40 mg. Patients with CNS leukemia at diagnosis received twice-weekly doses of IT cytarabine until CSF was clear of blasts cells on 3 consecutive examinations.
IT methotrexate dosage per age: less than one year: 6 mg; at least 1 year, but less than 2 years: 8 mg; at least 2 years, but less than 3 years: 10 mg; and at least 3 years: 12 mg.