LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
LAL-AR-N-2005: Study Treatment for Children High Risk Acute Lymphoblastic Leukemia
The study objective is to improve the global results obtained with LAL-AR-93 study, reaching an event free survival between 60-70%.
Identify patients with bad prognosis, with minimal residual disease,who can benefit of allogenic bone marrow transplantation
INDUCTION TREATMENT
Systemic chemotherapy:
PREDNISOLONE 60 mg/m2 /day, oral or i.v. x 21 days (1 to 22) 30 mg/m2 /day, oral or i.v. x 7 days (23 to 29)
DAUNORUBICIN 30 mg/m2 , i.v. days 1,8,15 and 22
VINCRISTINE 1,5 mg/m2, i.v. days 1,8,15 and 22
L-ASPARAGINASE 10.000U/m2 i.m or i.v day 9,11,13,16,18,20,23,25 and 27
CYCLOPHOSPHAMIDE 500 mg/m2 i.v. days 1,2 and 29
Intrathecal chemotherapy:
Days 1 and 22 according age:
Age <1 years 1-3 years >3 years
Methotrexate (MTX), mg 5 8 12 Ara-C, mg 16 20 30 Hydrocortisone,mg 10 10 20
Patients with <10% blasts in M.O (day 14), and in complete response on week 5 or 6, and without MDR, start consolidation-intensification phase.
Patients with >10% blasts in MO day +14 or without CR after induction treatment, start consolidation-intensification phase and identifier a donor for a transplantation.
CONSOLIDATION/INTENSIFICATION (C.I.)
Two sequential cycles, alternating bloc I and bloc II
BLOC I
DEXAMETHASONE 10 mg/m2/d vo. days 1 to 5 and 5 mg/m2/d vo. days 6 and 7
VINCRISTINE 1.5 mg/m2/d, i.v. days 1 and 8
METHOTREXATE 5 g/m2 24 hours infusion + AF, day 1
ARA-C 1 g/m2/12 h, i.v., days 5 and 6
MERCAPTOPURINE 100 mg/m2/d, oral, days 1 to 5
CYCLOPHOSPHAMIDE 500 mg/m2 i.v. el day +8
INTRATHECAL CHEMOTHERAPY day 1.
BLOC II
DEXAMETHASONE 10 mg/m2/d, v o. days 1-5 and 5 mg/m2/d, v o. days 6 and 7
VINCRISTINE 1.5 mg/m2/d, days 1 and 8
METHOTREXATE 5 g/m2 24 h infusion + AF, day 1
ARA-C 1 g/m2 i.v/12 h, days 5 and 6
DAUNORUBICINE 30 mg/m2 i.v.day 1
L-ASPARAGINASE 20.000 u/m2/d, i.m. or i.v. day 7
INTRATHECAL CHEMOTHERAPY day 1
Patients with CR and MRD negative, follow chemotherapy. Patients with MDR >0.01% after second cycle or considered previously MRD are candidates to allogenic transplantation after second cycle.
REINDUCTION/INTENSIFICATION TREATMENT (R.I.)
PREDNISOLONE 60 mg/m2/d, oral x 14 days (1-14) 30 mg/m2/d, oral x 7 days (15-22)
VINCRISTINE 1.5 mg/m2, i.v. x 2 days 1 and 8
DAUNORUBICINE 30 mg/m2 i.v x 2 , days 1 and 8
CYCLOPHOSPHAMIDE 500 mg/m2 I.V. day 15
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METHOTREXATE 3 g/m2 /24 h infusion + AF day 29
MERCAPTOPURINE 50 mg/m2/d, oral, days 29-35 and 43-50
ARA-C 1 g/m2/12 h., i.v., days 43 and 44
INTRATHECAL CHEMOTHERAPY , days 1, 15, 29 and 43
MAINTENANACE TREATMENT (M1)
Six cycles of:
MERCAPTOPURINE 50 mg/m2/d, oral x 21 days (1-21)
METHOTREXATE 20 mg/m2/d, i.m. /week x 3 (1,7,14)
PREDNISOLONE 60 mg/m2/d, oral x 7 days (22-28)
VINCRISTINE 1.5 mg/m2 i.v.day 22
ASPARAGINASE 20.000 u/m2 i.m. day 22
INTRATHECAL CHEMOTHERAPY day 22
MAINTENANCE TREATMENT (M2)
Diary mercaptopurine and weekly methotrexate at previous doses, until complete 24 months.
Inclusion Criteria:
Exclusion Criteria: