Details of treatment for the randomized regimens
Phase and drug . | Dose . | Schedule . |
|---|---|---|
| Induction, 4 wk | ||
| IT cytarabine | Age-adjusted† | Day 0 |
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 7, 14, 21 |
| Asparaginase‡ | 6000 U/m2 | M, W, F × 9 doses |
| Prednisone | 40 mg/m2/d | Days 0-27 |
| IT MTX | Age-adjusted† | Days 7, 28 |
| Consolidation, 4 wk | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Day 0 |
| Prednisone | Taper | Days 0-10 |
| Mercaptopurine or | 75 mg/m2/d | Days 1-27 |
| Thioguanine§ | 50 or 60 mg/m2/d | Days 1-27 |
| IT MTX or | Age-adjusted† | Days 7, 14, 21 |
| ITT | Age-adjusted† | Days 7, 14, 21 |
| IM no. 1, 8 wk | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 28 |
| Prednisone | 40 mg/m2/d | Days 0-4, 28-32 |
| Mercaptopurine or | 75 mg/m2/d | Days 0-49 |
| Thioguanine§ | 50 or 60 mg/m2/d | Days 0-49 |
| MTX | 20 mg/m2/d | Weekly × 8 doses |
| DI no. 1, 8 wk | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 7, 14 |
| Asparaginase‡ | 6000 U/m2 | M, W, F × 6 doses |
| Dexamethasone | 10 mg/m2/d | Days 0-6, 14-20 |
| Doxorubicin | 25 mg/m2/d | Days 0, 7, 14 |
| Cytarabine | 75 mg/m2/d | Days 28-31, 35-38 |
| Cyclophosphamide | 1000 mg/m2 | Day 28 |
| Thioguanine | 60 mg/m2/d | Days 28-41 |
| IT MTX or | Age-adjusted† | Days 0, 28, 35 |
| ITT | Age-adjusted† | Days 0, 28, 35 |
| IM no. 2, 8 wk | ||
| As in “IM no. 1” | — | — |
| DI no. 2, 8 wk | ||
| As in “DI no. 1” | — | — |
| Maintenance,*12-wk cycles | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 28, 56 |
| Prednisone | 40 mg/m2/d | Days 0-4, 28-32, 56-60 |
| Mercaptopurine or | 75 mg/m2/d | Daily |
| Thioguanine§ | 50 or 60 mg/m2/d | Daily |
| MTX (oral) | 20 mg/m2/dose | Weekly |
| IT MTX or | Age-adjusted† | Day 0 |
| ITT | Age-adjusted† | Day 0 |
Phase and drug . | Dose . | Schedule . |
|---|---|---|
| Induction, 4 wk | ||
| IT cytarabine | Age-adjusted† | Day 0 |
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 7, 14, 21 |
| Asparaginase‡ | 6000 U/m2 | M, W, F × 9 doses |
| Prednisone | 40 mg/m2/d | Days 0-27 |
| IT MTX | Age-adjusted† | Days 7, 28 |
| Consolidation, 4 wk | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Day 0 |
| Prednisone | Taper | Days 0-10 |
| Mercaptopurine or | 75 mg/m2/d | Days 1-27 |
| Thioguanine§ | 50 or 60 mg/m2/d | Days 1-27 |
| IT MTX or | Age-adjusted† | Days 7, 14, 21 |
| ITT | Age-adjusted† | Days 7, 14, 21 |
| IM no. 1, 8 wk | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 28 |
| Prednisone | 40 mg/m2/d | Days 0-4, 28-32 |
| Mercaptopurine or | 75 mg/m2/d | Days 0-49 |
| Thioguanine§ | 50 or 60 mg/m2/d | Days 0-49 |
| MTX | 20 mg/m2/d | Weekly × 8 doses |
| DI no. 1, 8 wk | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 7, 14 |
| Asparaginase‡ | 6000 U/m2 | M, W, F × 6 doses |
| Dexamethasone | 10 mg/m2/d | Days 0-6, 14-20 |
| Doxorubicin | 25 mg/m2/d | Days 0, 7, 14 |
| Cytarabine | 75 mg/m2/d | Days 28-31, 35-38 |
| Cyclophosphamide | 1000 mg/m2 | Day 28 |
| Thioguanine | 60 mg/m2/d | Days 28-41 |
| IT MTX or | Age-adjusted† | Days 0, 28, 35 |
| ITT | Age-adjusted† | Days 0, 28, 35 |
| IM no. 2, 8 wk | ||
| As in “IM no. 1” | — | — |
| DI no. 2, 8 wk | ||
| As in “DI no. 1” | — | — |
| Maintenance,*12-wk cycles | ||
| Vincristine | 1.5 mg/m2 (2 mg max) | Days 0, 28, 56 |
| Prednisone | 40 mg/m2/d | Days 0-4, 28-32, 56-60 |
| Mercaptopurine or | 75 mg/m2/d | Daily |
| Thioguanine§ | 50 or 60 mg/m2/d | Daily |
| MTX (oral) | 20 mg/m2/dose | Weekly |
| IT MTX or | Age-adjusted† | Day 0 |
| ITT | Age-adjusted† | Day 0 |
Total duration of treatment for boys was 38 months; for girls, 26 months.
Intrathecal; see Table 2 for dosing.
Asparaginase preparation: E coli (Elspar; Merck, Whitehouse Station, NJ); Erwinia asparaginase replaced Elspar following severe allergic reactions.
The 100% targeted dose of thioguanine was changed from 60 to 50 mg/m2/d in February 1998.