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 |
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
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
(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
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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
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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1515 Holcombe Blvd
Houston, Texas 77030
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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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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1475 NW 12th Ave
Miami, Florida 33136
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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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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