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

PETHEMA Foundation

Status and phase

Completed

Phase 4

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: Mercaptopurine

Drug: Prednisone

Drug: VP-16

Drug: Cytosine Arabinoside

Drug: Daunorubicin

Drug: Cyclophosphamide

Drug: Methotrexate

Drug: L-Asparaginase

Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT00526175

LAL-BR/2001

Details and patient eligibility

About

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

Full 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)

Enrollment

150 estimated patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

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
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