Title
Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Phase
Phase 2Lead Sponsor
Renato MelaragnoStudy Type
InterventionalStatus
SuspendedIndication/Condition
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)Intervention/Treatment
imatinib ...Study Participants
20The 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+.
patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.
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.
