CT-011 MAb in DLBCL Patients Following ASCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532259
Recruitment Status : Completed
First Posted : September 20, 2007
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Information provided by (Responsible Party):
CureTech Ltd

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Large Cell, Diffuse Lymphoma, Mixed Cell, Diffuse Primary Mediastinal Large B-Cell Lymphoma Drug: CT-011 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: CT-011
The monoclonal antibody termed CT-011 (currently, pidilizumab).
Drug: CT-011
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

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT). ]
    PFS (progression-free survival ) will be determined at the eligible patient populations

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00532259

  Show 27 Study Locations
Sponsors and Collaborators
CureTech Ltd
Principal Investigator: Leo I Gordon, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CureTech Ltd Identifier: NCT00532259     History of Changes
Other Study ID Numbers: CT-2007-01
First Posted: September 20, 2007    Key Record Dates
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014
Last Verified: September 2014

Keywords provided by CureTech Ltd:
Lymphoma, Large B-Cell, Diffuse
Transformed Follicular Lymphoma
Stem cell transplantation

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs