CT-011 MAb in DLBCL Patients Following ASCT
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
1 other identifier
interventional
72
3 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
Typical duration for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 20, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
September 12, 2014
CompletedSeptember 12, 2014
September 1, 2014
3.8 years
September 19, 2007
September 22, 2013
September 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
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 Outcomes (1)
Overall Survival
within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
Study Arms (1)
CT-011
EXPERIMENTALThe monoclonal antibody termed CT-011 (currently, pidilizumab).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CureTech Ltdlead
Study Sites (27)
Moores UCSD Cancer Center
La Jolla, California, 92093-0706, United States
Scripps Cancer Center
San Diego, California, 92121, United States
Emory University-Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestestern Memorial Hospital
Chicago, Illinois, 60611-3008, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109-0473, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University
Colombus, Ohio, 43210, United States
Temple University
Philadelphia, Pennsylvania, 19111-2442, United States
The University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29605, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Jaslok Hospital and Research Centre
Mumbai, Maharashtra, 400026, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004, India
Gujarat Cancer and Research Institute
Ahmedabad, 380016, India
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, 110085, India
Rambam Medical Center
Haifa, Israel
Hadassah Medical Organization
Jerusalem, Israel
Chaim Sheba Medical Center
Tel Hashomaer, Ramat Gan, Israel
Related Publications (1)
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.
PMID: 24127452DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Resaerch
- Organization
- CureTech Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Leo I Gordon, MD
Northwestern University Feinberg School of Medicine
- PRINCIPAL INVESTIGATOR
Arnon Nagler, MD
Chaim Sheba Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 20, 2007
Study Start
October 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
September 12, 2014
Results First Posted
September 12, 2014
Record last verified: 2014-09