Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma
|ClinicalTrials.gov Identifier: NCT00904722|
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : June 3, 2016
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: CT-011 Drug: Rituximab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma|
|Study Start Date :||January 2010|
|Primary Completion Date :||April 2015|
|Study Completion Date :||April 2015|
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
- Overall Response Rate [ Time Frame: Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse. ]Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.
- Progression-Free Survival [ Time Frame: Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse. ]Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|