A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma (VERTICAL)
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|ClinicalTrials.gov Identifier: NCT00636792|
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : June 22, 2011
Last Update Posted : January 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: VELCADE Drug: Bendamustine Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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.
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.Drug: Bendamustine
Bendamustine administered IV over 30-60 minutes after VELCADE on Days 1 and 2 of each cycleDrug: Rituximab
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
- Number of Participants With Complete Response [ Time Frame: 12 weeks after the last subject completes their end of treatment visit. ]Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
- Number of Participants With Overall Response (Complete and Partial Response) [ Time Frame: 12 weeks after the last subject completes their end of treatment visit ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636792
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20057|
|United States, North Dakota|
|MidDakota Clinic - Cancer Treatment and Research Center|
|Bismarck, North Dakota, United States, 58501|
|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|