Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma

Completed · Phase 1

Conditions studied: B-Cell Malignancies

In brief

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma

Key facts

Study ID

NCT01775631

Run by

Bristol-Myers Squibb

People needed

47

Starts

2013-03-01

Expected to finish

2016-08-01

Last updated by the study team

2017-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG)
• 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

You may not qualify if…

• Active or progressing brain metastases
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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