S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment
RATIONALE: 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. Monoclonal antibodies, such as rituximab, can block cancer cell 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 cell-killing substances to them. Giving bendamustine together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving bendamustine together with rituximab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia that has not responded to previous treatment.
Drug: bendamustine hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia|
- Response rate (CR, CRi, or PR) [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- To test whether the response rate (CR, CRi, or PR) in patients with purine analog-refractory, B-cell chronic lymphocytic leukemia (CLL) after treatment with the combination of bendamustine hydrochloride and rituximab is sufficiently high to warrant further investigation.
- To evaluate the safety and tolerability of bendamustine hydrochloride and rituximab in patients with B-cell CLL who are refractory to treatment with a purine-nucleoside analog-containing regimen.
- To investigate, in a preliminary manner, the prognostic effects of pre-treatment cytogenetic abnormalities identified by conventional cytogenetics and by FISH analyses on response to treatment in this patient population.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1 and bendamustine IV over 30 minutes on days 1-2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. In course 1 only, patients also receive rituximab IV on day 2.
After completion of study treatment, patients are followed up periodically for 2 years.
|Study Chair:||Matt E. Kalaycio, MD||The Cleveland Clinic|