This is a phase 2, single-arm, open label, multicenter study evaluating the efficacy and safety of the combination of VELCADE, bendamustine, and rituximab in subjects with relapsed or refractory follicular lymphoma, who have received 4 or more doses of rituximab. Subjects may be sensitive or refractory to prior therapies, including rituximab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
VELCADE administered as a 3- to 5-second intravenous (IV) bolus prior to Bendamustine and Rituximab on Days 1,8,15 and 22 of each cycle.
Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycle
Rituximab administered by IV infusion after VELCADE and Bendamustine on Days 1, 8, 15 and 22 of Cycle 1, and on Day 1 of Cycles 2, 3, 4 and 5
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
MidDakota Clinic - Cancer Treatment and Research Center
Bismarck, North Dakota, United States
Number of Participants With Complete Response
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
Time frame: 12 weeks after the last subject completes their end of treatment visit.
Number of Participants With Overall Response (Complete and Partial Response)
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.
Time frame: 12 weeks after the last subject completes their end of treatment visit
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