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

Phase 2

Suspended

• Conditions: Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
• Interventions: Drug: Imatinib Mesylate

• Registration Number: NCT01222013
• Lead Sponsor: Renato Melaragno

Brief Summary

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+.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. 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.
2. 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.
3. Life expectation > 8 weeks.
4. Medications: antineoplastic treatment-naïve, including corticotherapy, except for patients that performed Induction for ALL (33 days) exactly as this protocol.
5. Signed ICF by child legal responsible.
6. 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

1. Any inclusion criteria missing.
2. Pregnant patient or breastfeeding.
3. Patient considered incapable to follow purposed treatment.
4. Subject with infectious process, in activity, grade IV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib Mesylate	Imatinib Mesylate	-

Primary Outcome Measures

Name	Time	Method
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+.	Up to 24 months.	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+.	Up to 24 months	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.