Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-II: Multicenter phase II clinical trial for children with non-T-ALL in intermediate risk group stratified by the minimal residual disease (MRD).
Phase 2
- Conditions
- first relapsed acute lymphoblastic leukemia in children
- Registration Number
- JPRN-UMIN000002025
- Lead Sponsor
- Japanese Peditric Leukemia/Lymphoma Study Group(JPLSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with mature B-ALL, Ph positive ALL or MLL rearrangement positive ALL. 2. Down syndrome 3. Have any severe bleeding in CNS system. 4. Have an uncontrolled systemic infection. 5. Are pregnant or lactating. 6. Have received a HSCT or organ transplantation. 7. Have a congenital or aquired immunodifficiency syndrome. 8. Patients can not be treated with one or more drugs in the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3 year-event free survival rate (3y-EFS)
- Secondary Outcome Measures
Name Time Method 3 year-overall survival rate(3y-OS) Remission induction rate 3y-EFS and 3y-OS in MRD positive and negative groups Second progression free survival Incidence rates of adverse effects