CT-011 MAb in DLBCL Patients Following ASCT

Completed · Phase 2

Conditions studied: Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00532259

Run by

CureTech Ltd

People needed

72

Starts

2007-10-01

Expected to finish

2011-08-01

Last updated by the study team

2014-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient's age is 18 years or older, both genders.
• Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
• The lymphoma is chemosensitive.
• The lymphoma did not progress since pre-transplant chemotherapy.
• ECOG performance status 0-1.

You may not qualify if…

• Serious other illness.
• Active autoimmune disease.
• Type 1 diabetes.
• Known immune deficiency.
• Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
• Active bacterial, fungal, or viral infection.
• Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
• Pregnant or nursing (positive pregnancy test).
• Other concurrent clinical study or investigational therapy.

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States
• Scripps Cancer Center — San Diego, California, United States
• Emory University-Winship Cancer Institute — Atlanta, Georgia, United States
• Northside Hospital — 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

Full record on ClinicalTrials.gov

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