Back to resultsStudy for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Primary Purpose
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Status
Suspended
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib Mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imatinib Mesylate
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01222013
Brief Title
Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Official Title
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Suspended
Why Stopped
Study was suspended before recruitment, due to logistic issues.
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Renato Melaragno
4. Oversight
Data Monitoring Committee
No
5. Study Description
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+.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imatinib Mesylate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imatinib Mesylate
Other Intervention Name(s)
Glivec, MI
Intervention Description
patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.
Primary Outcome Measure Information:
Title
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+.
Description
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.
Secondary Outcome Measure Information:
Title
Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
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