NCT00526175

LAL-BR/2001: Study Treatment to Low Risk ALL

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Prednisone	60 mg/m2 day, i.v. or oral, dyas 1 to 27 30 mg/m2 day, i.v. or oral, days 28 to 35
DRUG	Vincristine	1,5 mg/m2 i.v., days 8, 15, 22 and 28
DRUG	Daunorubicin	30 mg/m2, i.v., days 8 and 15
DRUG	L-Asparaginase	10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.
DRUG	Cyclophosphamide	1000 mg/m2, i.v., day 22.
DRUG	Methotrexate	Age \<1 year 1-2 years 2-3 years \> 3 years MTX 5 mg 8 mg 10 mg 12 mg
DRUG	Cytosine Arabinoside	Edad \<1 year 1-2 years 2-3 years \> 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
DRUG	Mercaptopurine	50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
DRUG	VP-16	150 mg/m2 i.v., days 14-15 and 42-43

Timeline

• Start date: 2001-06-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2007-09-10
• Last updated: 2016-01-20

Locations

25 sites across 1 country: Spain