Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing
substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine plus high-dose
cyclophosphamide and rituximab in treating patients who have previously untreated chronic
lymphocytic leukemia.
OBJECTIVES:
- 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
4 weeks.
Patient are followed every 3 months until death.
PROJECTED ACCRUAL: This study will accrue 30 patients within 3 years.
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