Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- JPRN-UMIN000000511
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
- Brief Summary
1. CR rate, 3-year EFS and OS rates for the whole cohort (N=443) CR rate: 86.0% 3-year EFS: 54.3 % (95%CI, 49.3-59.0%) 3-year OS: 73.2 % (95%CI, 68.3-77.4%) 3-year relapse rate: 30.3% (95%CI, 25.9-34.7%) 2. 3-year EFS and OS rates according to the risk group 1) Low risk (LR) group (N=135) 3-year EFS: 69.4 % (95%CI, 60.3-76.8%) 3-year OS: 92.5 % (95%CI, 85.5-96.3%) 2) Intermediate risk (IR) group (N=183) 3-year EFS: 57.3 % (95%CI, 49.3-64.5%) 3-year OS: 73.2 % (95%CI, 65.0-79.8%) 3) High risk (HR) group (N=54) 3-year EFS: 53.4 % (95%CI, 39.2-65.6%) 3-year OS: 66.8 % (95%CI, 51.1-78.4%)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 254
Not provided
1)CNS hemorrhage which is likely to interfere protocol therapy 2)uncontrolled DM 3)severe mental abnormalities 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)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 of the each risk group
- Secondary Outcome Measures
Name Time Method For the each risk group, 3-year EFS; rate of adverse events defined by Common Terminology Criteria for Adverse Events(CTCAE) ver3.0; compliance rate of protocol specified regimen. Overall, 3-year EFS and OS; induction remission rate; remission rate after initial course of induction chemotherapy; compliance rate of protocol specified regimen.