Spots Global Cancer Trial Database for LAL-BR/2001: Study Treatment to Low Risk ALL

Study Description

Brief Summary: The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease

Detailed Description: REMISION INDUCTION Systemic chemotherapy: Prednisolone (PDN): * 60 mg/m2 day, i.v. or p.o., days 1 to 27 * 30 mg/m2 day, i.v. or p.o., days 28 to 35 Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22. Intracranial chemotherapy Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22 CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1) * Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63 * MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56. * VP-16: 150 mg/m2 i.v., days 14-15 and 42-43 * ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43 * Intrathecal treatment, days 1, 28 and 56. REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23) Dexamethasone (DXM): * 6 mg/m2 day, p.o., days 1-21 * 3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35. MAINTENANCE TREATMENT (M-1) Continuous treatment * MP 50 mg/m2/day, p.o. * MTX 20 mg/m2/week, i.m. Reinductions * VCR: 1,5 mg/m2 i.v., day 1. * PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7 * L-ASA: 20.000 UI/m2, i.m. or i.v., day 1. * Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended. Intrathecal treatment: At the start of any reinduction cycle MAINTENANCE TREATMENT (M-2) (WEEKS 55-108) * MP 50 mg/m2/day, p.o. * MTX 20 mg/m2/week, i.m. * Intrathecal treatment, weeks 54 and 108 At the end of treatment should be done the study of MRD (flux cytometry)

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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