Phase I/II study of clofarabine, etoposide and cyclophosphamide (CLEC) chemotherapy in adult patients with refractory or relapse acute lymphoblastic leukemia (JALSG RR-ALL214)
Phase 1
- Conditions
- acute lymphoblastic leukemia (ALL) which is relapsed or refractory to induction therapy (including the ph chromosome positive ALL)
- Registration Number
- JPRN-UMIN000015373
- Lead Sponsor
- Japan Adult Leukemia Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1. CNS leukemia 2. Uncontrolled infection 3. Sever comorbidity (diabetes mellitus, infection or liver cirrhosis) 4. Complication of active malignant disease 5. Pregnant and/or lactating woman 6. Psychological disorder 7. Positive HBV, HIV infection 8. Judged to be inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I : tolerability, safety Phase II: CR (complete remission) rates, CRp rates
- Secondary Outcome Measures
Name Time Method Phase I: 1) CR (complete remission) rates, CRp rate, tolerability, safety, 2) adverse event rates, 3) Overall survival, 4) reccurrence free survival time, Phase II: 1) adverse event rates, 2) Overall survival, 3) reccurrence free survival time