LAL-BR/2001: Study Treatment to Low Risk ALL
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)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
2 years
No
Ribera Josep Mª, Dr
Study Chair
HOSPITAL GERMANS TRIAS I PUJOL
Spain: Ministry of Health
LAL-BR/2001
NCT00526175
June 2001
December 2013
Name | Location |
---|