Spots Global Cancer Trial Database for CT-011 MAb in DLBCL Patients Following ASCT
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Trial Identification
Brief Title: CT-011 MAb in DLBCL Patients Following ASCT
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
Study ID: NCT00532259
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores UCSD Cancer Center, La Jolla,, California, United States
Scripps Cancer Center, San Diego, California, United States
Northside Hospital, Atlanta,, Georgia, United States
Emory University-Winship Cancer Institute, Atlanta, Georgia, United States
Northwestestern Memorial Hospital, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
The University of Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University, Colombus, Ohio, United States
Temple University, Philadelphia, Pennsylvania, United States
The University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Cancer Center of the Carolinas, Greenville, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Baylor Sammons Cancer Center, Dallas,, Texas, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra, India
Gujarat Cancer and Research Institute, Ahmedabad, , India
Rajiv Gandhi Cancer Institute and Research Centre, Delhi, , India
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Organization, Jerusalem, , Israel
Chaim Sheba Medical Center, Tel Hashomaer, Ramat Gan, , Israel
Contact Details
Name: Leo I Gordon, MD
Affiliation: Northwestern University Feinberg School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Arnon Nagler, MD
Affiliation: Chaim Sheba Medical Center
Role: PRINCIPAL_INVESTIGATOR
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