A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Phase 2
- Conditions
- Acute promyelocytic leukemia
- Registration Number
- JPRN-UMIN000015348
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
17q12/RARA not detected genetically and cytogenetically APL with t(11;17)(q23;q12)/PLZF-RARA CNS hemorrhage which is likely to interfere protocol therapy Secondary APL due to previous chemotherapy or radiation therapy Unmanageable infectious disease including tuberculosis Any inappropriate status judged by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Three-year event-free survival rate
- Secondary Outcome Measures
Name Time Method Remission induction rate Molecular remission rate at the end of consolidation therapy Three-year overall survival rate Rate of DIC, APL-DS, and mortality during first remission induction therapy Rate of adverse events during ATO therapy Rate of adverse events