Phase II study of imatinib mesylate for treatment of Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in children: A Japanese Cooperative Trial
Phase 2
- Conditions
- Philadelphia Chromosome-positive acute lymphoblastic leukemia
- Registration Number
- JPRN-C000000290
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
Not provided
Exclusion Criteria
Intracranial hemorrhage. Heart failure requiring treatment. Chronic renal failure. Active uncontrolled infections. Diabetes mellitus. Liver chirrhosis. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent. Female patients who are pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy of imatinib mesylate for children with Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) assessed by a molecular quantification technique.
- Secondary Outcome Measures
Name Time Method To evaluate the event-free survival for patients with Ph+ ALL assessed by a life table analysis, To evaluate the rate of patients who receive allogeneic stem cell transplantation (SCT) in the first complete remission (CR). To evaluate the safety of the regimen.