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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Prednisone
* Drug: Vincristine
* Drug: Daunorubicin
* Drug: L-Asparaginase
* Drug: Cyclophosphamide
* Drug: Methotrexate
* Drug: Cytosine Arabinoside
* Drug: Mercaptopurine
* Drug: VP-16


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leukemia, Minimal Residual Disease