Trial Information

Summary: A Study of the Monoclonal Antibody CT-011 in Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation.

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 (60 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 16 months after the first administration of CT-011. Approximately 70 patients will participate in this study.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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, or Hepatitis C antibody.
  • Pregnant or nursing (positive pregnancy test).
  • Other concurrent clinical study or investigational therapy.

    • Contact:

    Chaim Sheba Medical Center
    Located in:
    Tel-Hashomer, Israel, 52621
    Telephone: 972 (3) 5305830   
    Email:

    		 

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    Trial listings updated: August 28, 2008 at 2:59:52 PM


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