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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01775631
Phase
PHASE1
Status
Completed

Conditions

  • B-Cell Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urelumab — BIOLOGICAL
  • Rituximab — BIOLOGICAL

Study Details

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

Key Dates

Start date
Mar 31, 2013
Status verified
Sep 2016
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm -1 - Urelumab + Rituximab
    Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days
  • Experimental: Arm 1 - Urelumab + Rituximab
    Urelumab (BMS-663513) flat dose intravenous infusion on specified days Rituximab intravenous flat dose infusion on specified days

Primary Outcome Measure

Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities [ Time Frame: Up to 60 days after last dose of Urelumab ]

Locations (15)

FacilityCityStateZIPSite coordinators
Ucla Department Of MedicineLos AngelesCalifornia90095-
Stanford University Medical CenterStanfordCalifornia94305-
University Of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
University Of Iowa Hospitals And ClinicsIowa CityIowa52242-
Dana Faber Cancer InstituteBostonMassachusetts02215-
University Of Michigan Health SystemAnn ArborMichigan48109-
Karmanos Cancer InstituteDetroitMichigan48201-
John Theurer Cancer CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York11065-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Providence Cancer Center Oncology And Hematology Care- EastsidePortlandOregon97213-
Hospital Of The University Of PennsylvaniaPhiladelphiaPennsylvania19104-
The University Of Texas Md Anderson Cancer CenterHoustonTexas77030-
University Of Virginia School Of MedicineCharlottesvilleVirginia22908-

Find similar trials in Los Angeles, CA

By research site
Ucla Department Of Medicine· Los Angeles, CAStanford University Medical Center· Stanford, CAUniversity Of Miami Sylvester Comprehensive Cancer Center· Miami, FLMount Sinai Comprehensive Cancer Center· Miami Beach, FLUniversity Of Iowa Hospitals And Clinics· Iowa City, IADana Faber Cancer Institute· Boston, MA

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