A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Phase 2
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- NCT00774332
- Lead Sponsor
- Cooperative Study Group A for Hematology
- Brief Summary
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
- Detailed Description
The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- Patients with relapsed/resistant acute lymphoblastic leukemia
- Patients must be between 15 and 65 years of age.
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
- Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
- Adequate kidney function (estimated Ccr >50 ml/min)
Exclusion Criteria
- Patients with CNS involvement of leukemic blasts will not be excluded.
- Patients with extramedullary relapse(s) only will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Duration of complete remission, disease-free survival, overall survival, toxicities 2009
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of