NCT00939328

S0902 Bendamustine and Rituximab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Not Responded to Previous Treatment

S0902, Phase II Study of Bendamustine Plus Rituximab for the Treatment of Refractory B-Cell Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
DRUG	bendamustine hydrochloride

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-07-15
• Last updated: 2015-03-06