CT-011 MAb in DLBCL Patients Following ASCT
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.
Lymphoma, Large Cell, Diffuse
Lymphoma, Mixed Cell, Diffuse
Primary Mediastinal Large B-Cell Lymphoma
|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 Patients With Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation|
- Progression-free Survival [ Time Frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT). ] [ Designated as safety issue: No ]PFS (progression-free survival ) will be determined at the eligible patient populations
- Overall Survival [ Time Frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
The monoclonal antibody termed CT-011 (currently, pidilizumab).
IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
Other Name: Pidilizumab
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532259
Show 27 Study Locations
|Principal Investigator:||Leo I Gordon, MD||Northwestern University Feinberg School of Medicine|
|Principal Investigator:||Arnon Nagler, MD||Chaim Sheba Medical Center|