EORTC-CLCG 58881: treatment protocols for low- and high-risk patients
| Drug . | Dose . | Days of administration* . |
|---|---|---|
| Induction: protocol IA | ||
| Prednisolone (PO) | 60 mg/m2 | 1-28 |
| Vincristine (IV) | 1.5 mg/m2 (max. 2.5 mg) | 8, 15, 22, 29 |
| Daunorubicin (IV) | 30 mg/m2 | 8, 15, 22, 29 |
| Methotrexate (intrathecal) | 12 mg† | 1, 8, 22, 38, 52 |
| According to randomization | ||
| E coli–asparaginase (IV) or | 10 000 IU/m2 | 12, 15, 18, 22, 25, 29, 32, 35 |
| Erwinia-asparaginase (IV) | 10 000 IU/m2 | 12, 15, 18, 22, 25, 29, 32, 35 |
| Consolidation: protocol IB | ||
| Cyclophosphamide (IV) | 1 000 mg/m2 | 36, 63 |
| Cytarabine (IV) | 75 mg/m2 | 38-41, 45-48, 52-55, 59-62 |
| 6-Mercaptopurine (PO) | 60 mg/m2 | 36-63 |
| Interval therapy | ||
| 6-Mercaptopurine (PO) | 25 mg/m2 | 1-56 |
| Methotrexate (24 h IV infusion with leucovorin rescue) | 5 000 mg/m2 | 8, 22, 36, 50 |
| Methotrexate (intrathecal) | 12 mg† | 9, 23, 37, 51 |
| According to randomization for high-risk patients | ||
| Cytarabine (IV) | 1 000 mg/m2 | 9, 10, 23, 24, 37, 38, 51, 52 |
| Reinduction: protocol II | ||
| Dexamethasone (PO) | 10 mg/m2 | 1-21 |
| Vincristine (IV) | 1.5 mg/m2 (max. 2.5 mg) | 8, 15, 22, 29 |
| Doxorubicin (IV) | 30 mg/m2 | 8, 15, 22, 29 |
| Methotrexate (intrathecal) | 12 mg† | 38 |
| Cyclophosphamide (IV) | 1 000 mg/m2 | 36 |
| Cytarabine (IV) | 75 mg/m2 | 38-41, 45-48 |
| 6-Thioguanine (PO) | 60 mg/m2 | 36-49 |
| According to randomization | ||
| E coli–asparaginase (IV) or | 10 000 IU/m2 | 8, 11, 15, 18 |
| Erwinia-asparaginase (IV) | 10 000 IU/m2 | 8, 11, 15, 18 |
| Drug . | Dose . | Days of administration* . |
|---|---|---|
| Induction: protocol IA | ||
| Prednisolone (PO) | 60 mg/m2 | 1-28 |
| Vincristine (IV) | 1.5 mg/m2 (max. 2.5 mg) | 8, 15, 22, 29 |
| Daunorubicin (IV) | 30 mg/m2 | 8, 15, 22, 29 |
| Methotrexate (intrathecal) | 12 mg† | 1, 8, 22, 38, 52 |
| According to randomization | ||
| E coli–asparaginase (IV) or | 10 000 IU/m2 | 12, 15, 18, 22, 25, 29, 32, 35 |
| Erwinia-asparaginase (IV) | 10 000 IU/m2 | 12, 15, 18, 22, 25, 29, 32, 35 |
| Consolidation: protocol IB | ||
| Cyclophosphamide (IV) | 1 000 mg/m2 | 36, 63 |
| Cytarabine (IV) | 75 mg/m2 | 38-41, 45-48, 52-55, 59-62 |
| 6-Mercaptopurine (PO) | 60 mg/m2 | 36-63 |
| Interval therapy | ||
| 6-Mercaptopurine (PO) | 25 mg/m2 | 1-56 |
| Methotrexate (24 h IV infusion with leucovorin rescue) | 5 000 mg/m2 | 8, 22, 36, 50 |
| Methotrexate (intrathecal) | 12 mg† | 9, 23, 37, 51 |
| According to randomization for high-risk patients | ||
| Cytarabine (IV) | 1 000 mg/m2 | 9, 10, 23, 24, 37, 38, 51, 52 |
| Reinduction: protocol II | ||
| Dexamethasone (PO) | 10 mg/m2 | 1-21 |
| Vincristine (IV) | 1.5 mg/m2 (max. 2.5 mg) | 8, 15, 22, 29 |
| Doxorubicin (IV) | 30 mg/m2 | 8, 15, 22, 29 |
| Methotrexate (intrathecal) | 12 mg† | 38 |
| Cyclophosphamide (IV) | 1 000 mg/m2 | 36 |
| Cytarabine (IV) | 75 mg/m2 | 38-41, 45-48 |
| 6-Thioguanine (PO) | 60 mg/m2 | 36-49 |
| According to randomization | ||
| E coli–asparaginase (IV) or | 10 000 IU/m2 | 8, 11, 15, 18 |
| Erwinia-asparaginase (IV) | 10 000 IU/m2 | 8, 11, 15, 18 |
Maintenance therapy was a combination of daily oral mercaptopurine adjusted to maintain leukocytes between 2000 and 3000/μL and methotrexate 20 mg/m2 once a week. According to randomization, some patients received intravenous mercaptopurine 1000 mg/m2 every 4 weeks.
Adjustments were made for clinical condition and marrow recovery.
Doses were adjusted for children under age 3 years.