CT-011 MAb in DLBCL Patients Following ASCT

Phase 2

Completed

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

Interventions: Drug: CT-011

Registration Number: NCT00532259

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	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

Name	Time	Method
Overall Survival	within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).

Trial Locations

Locations (27): Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
The University of Chicago
🇺🇸
Chicago, Illinois, United States
Jaslok Hospital and Research Centre
🇮🇳
Mumbai, Maharashtra, India
Sarah Cannon Research Institute
🇺🇸
Nashville, Tennessee, United States
Gujarat Cancer and Research Institute
🇮🇳
Ahmedabad, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳
Pune, Maharashtra, India
Rajiv Gandhi Cancer Institute and Research Centre
🇮🇳
Delhi, India
Hadassah Medical Organization
🇮🇱
Jerusalem, Israel
Chaim Sheba Medical Center
🇮🇱
Tel Hashomaer, Ramat Gan, Israel
Rambam Medical Center
🇮🇱
Haifa, Israel
Emory University-Winship Cancer Institute
🇺🇸
Atlanta, Georgia, United States
Northwestestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Moores UCSD Cancer Center
🇺🇸
La Jolla,, California, United States
Scripps Cancer Center
🇺🇸
San Diego, California, United States
Northside Hospital
🇺🇸
Atlanta,, Georgia, United States
Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Temple University
🇺🇸
Philadelphia, Pennsylvania, United States
The University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Ohio State University
🇺🇸
Colombus, Ohio, United States
Baylor Sammons Cancer Center
🇺🇸
Dallas,, Texas, United States
M.D. Anderson Cancer Center
🇺🇸
Houston, Texas, 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
Cancer Center of the Carolinas
🇺🇸
Greenville, South Carolina, United States