Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM like Induction in children with ALL Ph+.

Official Title
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Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Conditions
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Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Intervention / Treatment
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* Drug: Imatinib Mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnose: therapy-naïve ALL, except for patients that performed Induction for ALL (33 days) exactly as this protocol and; documented Ph+, to be confirmed by conventional cytogenetic - t(9;22) (q34;q11) or FISH and/or gene BCR-ABL presence by RT-PCR or FISH. Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used during treatment. Pregnant women won't be included. Life expectation > 8 weeks. Medications: antineoplastic treatment-naïve, including corticotherapy, except for patients that performed Induction for ALL (33 days) exactly as this protocol. Signed ICF by child legal responsible. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP/TGO < 10 x ULN and albumin > 2 g/dl. Exclusion Criteria: Any inclusion criteria missing. Pregnant patient or breastfeeding. Patient considered incapable to follow purposed treatment. Subject with infectious process, in activity, grade IV.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib Mesylate<br> | Drug: Imatinib Mesylate<br>* patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.<br>* Other names: Glivec, MI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM like Induction in children with ALL Ph+. | Cytogenetic and molecular response will be evaluate at the end of Induction I (D33), before each consolidation block (HR 1, 2 and 3), before re-induction, before maintenanceand at the end of therapy. | Up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+. | Toxicity and tolerability will be verified in every visit according through: Adverse events during the study. Laboratory exams. Vital signs and body weight. Physical evaluation. Concomitant medication. | Up to 24 months |