Status:
UNKNOWN
A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Patients with CNS involvement of leukemic blasts will not be excluded.
- Patients with extramedullary relapse(s) only will be excluded.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00774332
Start Date
June 1 2006
End Date
December 1 2009
Last Update
October 17 2008
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea