CT-011 MAb in DLBCL Patients Following ASCT

September 8, 2014 updated by: CureTech Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380016
        • Gujarat Cancer and Research Institute
      • Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute And Research Centre
    • Maharashtra
      • Mumbai, Maharashtra, India, 400026
        • Jaslok Hospital and Research Centre
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Organization
      • Tel Hashomaer, Ramat Gan, Israel
        • Chaim Sheba Medical Center
  • United States
    • California
      • La Jolla,, California, United States, 92093-0706
        • Moores UCSD Cancer Center
      • San Diego, California, United States, 92121
        • Scripps Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University-Winship Cancer Institute
      • Atlanta,, Georgia, United States, 30342
        • Northside Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Chicago, Illinois, United States, 60611-3008
        • Northwestestern Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0473
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Colombus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111-2442
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15232
        • The University of Pittsburgh Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Center Of The Carolinas
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas,, Texas, United States, 75246
        • Baylor Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pidilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CureTech Ltd

Investigators

  • Principal Investigator: Leo I Gordon, MD, Northwestern University Feinberg School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-2007-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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