Leukemia Clinical Trial
Official title:
S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia
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.
OBJECTIVES:
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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