Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D05: Phase II Study of Risk Stratified Multi-drug Chemotherapy on Down Syndrome with Newly diagnosed Childhood Acute Myeloid Leukemia
Phase 2
- Conditions
- Acute myeloid Leukemia Myelodysplastic syndrome
- Registration Number
- JPRN-UMIN000000989
- 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
- 73
Inclusion Criteria
Not provided
Exclusion Criteria
1)CNS hemorrhage which is likely to intervent protocol therapy 2)uncontrolled DM 3)uncontrolled cardiac failure 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)CNS leukemia 8)any inappropriate status judged by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year event-free survival rate
- Secondary Outcome Measures
Name Time Method Remission rate after initial induction chemotherapy Remission rate for high risk group Three-year overall survival rate Two-year event free survival for each risk group Three-year overall survival for each risk group Incidence of FLT3-ITD Two-year event free survival with or without FLT3-ITD Incidence of adverse events during chemotherapy Compliance rate of protocol specified regimen Three-year event free survival of the patients less than 4 years old