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)
- 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
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Clemens M. Wendtner
Medizinische Universitaetsklinik I at the University of Cologne