A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL
The feasibility will be evaluated in terms of complete remission rate, duration of complete
remission, disease-free survival, overall survival, and toxicities.
- 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)
- Patients with CNS involvement of leukemic blasts will not be excluded.
- Patients with extramedullary relapse(s) only will be excluded.
Type of Study:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Duration of complete remission, disease-free survival, overall survival, toxicities
Outcome Time Frame:
Jung-Hee Lee, Doctor
Asan Medical Center
Korea: Food and Drug Administration
- Acute Lymphoblastic Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma