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)

Inclusion criteria

• Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously

Exclusion criteria

• Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
• Mixed forms of ALL
• Acute Leukemia no differentiate
• Patients with coronary disorders, valvular or hypertensive cardiopathy
• Patients with chronic liver disorders
• Chronic pulmonary disorders
• Renal insufficiency
• Neurologic disfunctions
• ECOG 3 and 4
• No signed consent form