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



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/7/2017
Start Date:March 2013
End Date:August 2016

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A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies

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

Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion
(part 2) of study= Parallel Design

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
15
sites
Charlotte, North Carolina 28211
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Boston, Massachusetts 02115
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Boston, MA
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Charlottesville, Virginia 22908
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Detroit, Michigan 48201
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Detroit, MI
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Hackensack, New Jersey 07601
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Hackensack, NJ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Los Angeles, CA
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Miami, FL
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Miami Beach, Florida 33140
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Portland, Oregon 97213
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Portland, OR
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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