Prospective observational study of relapsed and refractory pediatric acute lymphoblastic leukemia
Not Applicable
- Conditions
- acute lymphoblastic leukemia
- Registration Number
- JPRN-UMIN000019878
- Lead Sponsor
- Japanese Pediatric Leukemia/Lymphoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 year EFS in all cases, in subgroups according to risk classification in 1st relapse cases, or numbers of relapse. Odd ratio in reinduction rate between clofarabine regimens and other regimens. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate.
- Secondary Outcome Measures
Name Time Method 2 year OS in all cases, or in subgroups according to risk classification in 1st relapse cases or numbers of relapse. 2nd progression free survival rate. Reinduction rate. Odds ratio in EFS between clofarabine regimens and other regimens. Odds ratio in OS between clofarabine regimens and other regimens. OS according to regimens or drugs used in reinduction therapy. Correlation between results (IC50 values) of in vitro drug sensitivity tests and reinduction rate in patients treated by clofarabine.