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Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma
Not Recruiting
Trial ID: NCT01775631
Purpose
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
Official Title
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies
Eligibility
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
Intervention(s):
biological: Urelumab
biological: Rituximab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061