Chronic Lymphocytic Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and
bendamustine, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can
block cancer growth in different ways. Some block the ability of cancer cells to grow and
spread. Others find cancer cells and help kill them or carry cancer-killing substances to
them. It is not yet known whether giving fludarabine and cyclophosphamide together with
rituximab is more effective than giving bendamustine together with rituximab in treating
chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and
rituximab to see how well they work compared with bendamustine and rituximab in treating
patients with previously untreated B-cell chronic lymphocytic leukemia.
OBJECTIVES:
- 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
these regimens.
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
unacceptable toxicity.
- 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.
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