Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma
NCT ID: NCT01775631
Last Updated: 2017-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2013-03-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
NCT02253992
Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma
NCT01729806
Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies
NCT01744912
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT01647971
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
NCT02535286
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm -1 - Urelumab + Rituximab
Urelumab (BMS-663513) flat dose intravenous infusion on specified days
Rituximab intravenous flat dose infusion on specified days
Urelumab
Rituximab
Arm 1 - Urelumab + Rituximab
Urelumab (BMS-663513) flat dose intravenous infusion on specified days
Rituximab intravenous flat dose infusion on specified days
Urelumab
Rituximab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Urelumab
Rituximab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Progressed or refractory to at least 1 prior line of standard therapy
* Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens
* Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment
* Eastern Cooperative Oncology Group (ECOG) of 0 to 1
Exclusion Criteria
* Other concomitant malignancies (with some exceptions per protocol)
* Active or history of autoimmune disease
* Positive test for human immunodeficiency virus (HIV) 1\&2 or known Acquired immune deficiency syndrome (AIDS)
* History of any hepatitis (A, B or C)
* History of grade 3-4 drug-related hepatitis
* Known current drug or alcohol abuse
* Active tuberculosis (TB)
* Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ucla Department Of Medicine
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Providence Cancer Center Oncology And Hematology Care- Eastside
Portland, Oregon, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
University Of Virginia School Of Medicine
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA186-017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.