A Phase II Study of Fludarabine Induction With Sequential High Dose Cyclophosphamide and Rituximab as Consolidation Therapy for Previously Untreated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia
- Determine the response rate in patients with chronic lymphocytic leukemia treated with
sequential fludarabine, high dose cyclophosphamide, and rituximab.
- Survival up to 5 years
- Utilize flow cytometry and polymerase chain reaction as sensitive measures of minimal
residual disease in these patients.
OUTLINE: This is an open label study.
Patients receive fludarabine IV once daily for 5 days. Treatment is repeated every 4 weeks
for 3 or 6 courses.
Three weeks later, cyclophosphamide is administered intravenously every 2-3 weeks for 3
courses. Filgrastim (G-CSF) is administered on days 2-10. Beginning 4 weeks after the last
dose of cyclophosphamide, patients receive rituximab by intravenous infusion once weekly for
Patient are followed every 3 months until death.
PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Response was determined as inicated in the protocol. The catergories are: complete response, nodular partial response, partial response and failure.
Mark Adam Weiss, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|