S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
- 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
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Response rate (CR, CRi, or PR)
Matt E. Kalaycio, MD
The Cleveland Clinic
United States: Food and Drug Administration