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

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