Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
The goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma|
- Overall Response Rate [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]Overall response (OR) rate defined as complete + partial responses in participants with relapsed follicular lymphoma (FL_) who receive CT-011 in combination with rituximab.
|Study Start Date:||January 2010|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: CT-011 in combination with Rituximab
Combination of the immunotherapy drugs, CT-011 and rituximab.
Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days).
Other Name: Monoclonal Antibody CT-011Drug: Rituximab
Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
Other Name: Rituxan
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00904722
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Sattva S. Neelapu, MD||M.D. Anderson Cancer Center|