FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT00769522
- Lead Sponsor
- German CLL Study Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 564
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BR Rituximab - FCR Rituximab - FCR Cyclophosphamide - BR Bendamustine - FCR Fludarabine -
- Primary Outcome Measures
Name Time Method Progression-free survival rate after 24 months 2008-2015 estimated time point when 198 needed events for the final analysis(PD or deaths) have occured.
- Secondary Outcome Measures
Name Time Method Event-free survival 2008-2015 done within the final analysis
Minimal residual disease, complete response rates, and partial response rates 2008-2015 done within the final analysis
Duration of remission 2008-2015 done within the final analysis
Overall response rate 2008-2015 done within the final analysis
Response rates in and survival times in biological subgroups 2008-2015 done within the final analysis
Toxicity rates 2008-2015 done within the final analysis
Standard safety analysis 2008-2015 done within the final analysis
Overall survival 2008-2015 done within the final analysis
Quality of life 2008-2015 done within the final analysis
Trial Locations
- Locations (1)
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany