CT-011 MAb in DLBCL Patients Following ASCT

NCT ID: NCT00532259

Last Updated: 2014-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-08-31

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.

Conditions

Lymphoma, Large Cell, Diffuse; Lymphoma, Mixed Cell, Diffuse; Primary Mediastinal Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT-011

The monoclonal antibody termed CT-011 (currently, pidilizumab).

Group Type: EXPERIMENTAL

CT-011

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Pidilizumab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CureTech Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leo I Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Arnon Nagler, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

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

Hadassah Medical Organization

Jerusalem, , Israel

Chaim Sheba Medical Center

Tel Hashomaer, Ramat Gan, , Israel

Countries

United States; India; Israel

References

Armand P, Nagler A, Weller EA, Devine SM, Avigan DE, Chen YB, Kaminski MS, Holland HK, Winter JN, Mason JR, Fay JW, Rizzieri DA, Hosing CM, Ball ED, Uberti JP, Lazarus HM, Mapara MY, Gregory SA, Timmerman JM, Andorsky D, Or R, Waller EK, Rotem-Yehudar R, Gordon LI. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial. J Clin Oncol. 2013 Nov 20;31(33):4199-206. doi: 10.1200/JCO.2012.48.3685. Epub 2013 Oct 14.

Reference Type: DERIVED

PMID: 24127452 (View on PubMed)

Other Identifiers

CT-2007-01

Identifier Type: -

Identifier Source: org_study_id