Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL
- Determine the overall and progression-free survival of patients with B-cell
prolymphocytic leukemia treated with immunochemotherapy comprising fludarabine,
cyclophosphamide, and rituximab.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. Patients also receive
rituximab IV on day 0 in course 1 and on day 1 in courses 2-6. Treatment repeats every 28
days for up to 6 courses.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Michael Herold, MD, PhD
Helios Klinikum Erfurt
United States: Federal Government