NCT00774332UnknownPhase 2
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Cooperative Study Group A for Hematology2 sites in 2 countries37 target enrollmentStarted: June 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Duration of complete remission, disease-free survival, overall survival, toxicities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Duration of complete remission, disease-free survival, overall survival, toxicities
Time Frame: 2009
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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