Table 3.
High-Risk B and T-ALL Regimens (Adapted from Children’s Oncology Group AALL1131, AALL0431)
| Phase | Chemotherapy Agents | Schedule |
|---|---|---|
| Induction (35 days) | Dexamethasone PO (< 10 years of age)a | Days 1–14 |
| Prednisone PO (≥ 10 years of age)a | Days 1–28 | |
| Vincristine IV | Days 1, 8, 15, 22 | |
| Daunorubicin IV | Days 1, 8, 15, 22 | |
| Pegaspargase IM/IV | Day 4 | |
| Cytarabine IT | Day 1 (B-ALL CNS2 require more) | |
| Methotrexate IT | Days 8, 29 (also Days 15, 22 for CNS3) | |
| Consolidationb (56 days for B-ALL; 77 days for T-ALL) | Mercaptopurine PO | B-ALL: Days 1–14 and 29–42 |
| T-ALL: Days 8–21 and 50–63 | ||
| Cyclophosphamide IV | B-ALL: Days 1, 29 | |
| T-ALL: Days 8, 50 | ||
| Cytarabine IV | B-ALL: Days 1–4, 8–11, 29–32, 36–39 | |
| T-ALL: Days 8–11, 15–18, 50–53, 57–60 | ||
| Vincristine IV | B-ALL: Days 15, 22, 43, 50 | |
| T-ALL: Days 22, 29, 64, 71 | ||
| Pegaspargase IM/IV | B-ALL: Days 15, 43 | |
| T-ALL: Days 22, 64 | ||
| Methotrexate IT | B-ALL: Days 1, 8, 15, 22 | |
| T-ALL: Days 15, 22, 57, 64 (CNS3 omit d22) | ||
| Interim Maintenance (IM)c (63 days for B-ALL; 56 days for T-ALL) | Mercaptopurine PO | B-ALL only: Days 1–56 |
| Vincristine IV | B-ALL: Days 1, 15, 29, 43 | |
| T-ALL: Days 1, 11, 21, 31, 41 | ||
| High Dose Methotrexate IV | B-ALL only: Days 1, 15, 29, 43 | |
| Escalating Dose Methotrexate IV | T-ALL only: Days 1, 11, 21, 31, 41 | |
| Methotrexate IT | B-ALL: Days 1, 29 | |
| T-ALL: Days 1, 31 | ||
| Pegaspargase IV/IM | T-ALL only: Days 2, 22 | |
| Delayed Intensification (56 days for B-ALL; 63 days for T-ALL) | Dexamethasone PO | Days 1–7 and 15–21 |
| Thioguanine PO | B-ALL: Days 29–42 | |
| T-ALL: Days 36–49 | ||
| Vincristine IV | Days 1, 8, 15, 43, 50 (T-ALL omit d43) | |
| Doxorubicin IV | Days 1, 8, 15 | |
| Pegaspargase IM/IV | B-ALL: Days 4, 43 | |
| T-ALL: Days 4, 50 | ||
| Cyclophosphamide IV | Day 29 | |
| Cytarabine IV | Days 29–32 and 36–39 | |
| Methotrexate IT | Days 1, 29, 36 (T-ALL d29 given on d43) | |
| Maintenanced (12-week cycles for 2 years from IM) | Prednisone PO | Days 1–5, 29–33, and 57–61 |
| Mercaptopurine PO | Days 1–84 | |
| Methotrexate PO | Weekly starting Day 8 | |
| Vincristine IV | Days 1, 29, 57 | |
| Methotrexate IT | B-ALL: Days 1, 29 (first 4 cycles only) T-ALL: Day 1 only |
Notes: aT-ALL patients receive prednisone only Days 1–28. bT-ALL patients receive nelarabine Days 1–5 and 43–47. cT-ALL patients receive nelarabine on Days 29–33. dT-ALL patients receive an additional 3 cycles of nelarabine-based therapy prior to the start of maintenance (each cycle 84 days).
Abbreviations: PO, oral; IM, intramuscular; IV, intravenous; IT, intrathecal; CNS, central nervous system.