NCT00769522

FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Rituximab	cycle 1: 375 mg/m² i.v., day 0, q28d cycle 2-6: 500 mg/m² i.v., day 1, q28d
DRUG	Bendamustine	cycle 1-6: 90mg/m² i.v., day 1-2, q28d
DRUG	Cyclophosphamide	cycle 1-6: 250 mg/m² i.v., days 1-3, q28d
DRUG	Fludarabine	cycle 1-6: 25 mg/m² i.v., days 1-3, q28d

Timeline

• Start date: 2008-10-02
• Primary completion: 2011-07-01
• Completion: 2018-01-01
• First posted: 2008-10-09
• Last updated: 2024-12-31

Locations

1 site across 1 country: Germany