Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) CML-08: A Multi-Center Observational Study for Children with Chronic Phase of Chronic Myeloid Leukemia
Not Applicable
- Conditions
- Chronic Phase of Chronic Myeloid Leukemia (CML) in children
- Registration Number
- JPRN-UMIN000002581
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
CML without BCR-ABL rearrangement detectable by PCR
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year progression-free survival (5y-PFS)
- Secondary Outcome Measures
Name Time Method 5-year event-free survival (5y-EFS) 5-year overall survival (5y-OS) Cumulative rates of CHR, CCyR, and MMR Correlation of the prognosis with early BCR-ABL/ABL mRNA ratio Correlation of the efficacy with bone marrow markers, imatinib trough level, BCR-ABL kinase domain mutaions Incidence rates of adverse effects