Bendamustine and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
RATIONALE: 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. Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with bendamustine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bendamustine together with rituximab works in treating patients with relapsed B-cell chronic lymphocytic leukemia.
Drug: bendamustine hydrochloride
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Phase II Trial of Bendamustine in Combination With Rituximab for Patients With Relapsed Chronic Lymphocytic Leukemia. CLL2M Protocol of the German CLL-Study Group (GCLLSG)|
- Overall response rate [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- Determine the overall response rate in patients with relapsed B-cell chronic lymphocytic leukemia treated with bendamustine and rituximab.
- Determine the overall response rate in biologically defined risk groups treated with this regimen.
- Determine the duration of response, minimal residual disease response rate, and complete response rate in patients treated with this regimen.
- Determine the event-free survival of patients treated with this regimen.
- Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive rituximab on day 0 in course 1 and on day 1 in courses 2-6. Patients also receive bendamustine on days 1 and 2 in courses 1-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.
Show 58 Study Locations
|Study Chair:||Clemens M. Wendtner||Medizinische Universitaetsklinik I at the University of Cologne|