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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryCA186-017
NCT01775631

Trial Description

Summary

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 or Chronic Lymphocytic Leukemia (CLL)

Further Study Information

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

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of relapsed/refractory B-cell Malignancies per International Workshop Group (IWG) 2007 criteria or 2008 International Workshop on CLL (IWCLL) criteria
  • Progressed or refractory to at least 1 prior line of standard therapy
  • Subjects in Expansion cohorts are restricted to relapsed/refractory Chronic Lymphocytic Leukemia (CLL), diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are refractory to rituximab. Rituximab refractoriness is defined as progression during treatment on prior rituximab therapy or rituximab containing regimen or progression within 6 months from last received dose of rituximab
  • 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers SquibbStudy Director

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
  Email: Clinical.Trials@bms.com

Trial Sites

U.S.A.
California
  Los Angeles
 Jonsson Comprehensive Cancer Center at UCLA
 John Timmerman, Site 0011
  Stanford
 Stanford Cancer Center
 Ronald Levy, Site 0001
Florida
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Izidore Lossos, Site 0012
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Brian Link, Site 0004
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Mark Kaminski, Site 0006
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Martin Gutierrez, Site 0015
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Andrew Zelenetz, Site 0010
Oregon
  Portland
 Providence Cancer Center at Providence Portland Medical Center
 John Godwin, Site 0002

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01775631
ClinicalTrials.gov processed this data on June 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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