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+.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.
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.
Time frame: Up to 24 months.
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.
Time frame: Up to 24 months
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