Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Bendamustine and Rituximab (BR) in Patients With Previously Untreated Chronic Lymphocytic Leukaemia
- To compare the therapeutic efficacy of fludarabine phosphate, cyclophosphamide, and
rituximab vs bendamustine hydrochloride and rituximab in patients with previously
untreated B-cell chronic lymphocytic leukemia.
- To compare the incidence of major side effects (e.g., myelosuppression) associated with
these regimens in these patients.
- To compare the rate of infections and secondary neoplasias in patients treated with
OUTLINE: This is a multicenter study. Patients are stratified according to country and
disease stage. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine phosphate IV and cyclophosphamide IV on days 1-3.
Patients also receive rituximab IV on day 0 of course 1 and on day 1 of courses 2-6.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
- Arm II: Patients receive bendamustine hydrochloride IV on days 1 and 2. Patients also
receive rituximab as in arm I. Treatment repeats every 28 days for 6 courses in the
absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires (EORTC-C30 and EURO-QOL) at baseline and
then at 12, 24, 36, 48, and 60 months.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6
months for 3 years, and then once a year thereafter.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate after 24 months
estimated time point when 198 needed events for the final analysis(PD or deaths) have occured.
Barbara Eichhorst, MD
Medizinische Universitaetsklinik I at the University of Cologne
Germany: Paul-Ehrlich Institute