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
Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Ucla Department Of Medicine
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
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
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 110 days after last dose of Rituximab
Efficacy-Antitumor Activity of Urelumab in combination with Rituximab as measured by best overall response, progression-free survival, time to response, and duration of response
Time frame: Up to approximately 3 years
Maximum observed serum concentration (Cmax) of Urelumab and Rituximab
Time frame: 12 time points up to Day 60 of Follow-up
Time of maximum observed serum concentration (Tmax) of Urelumab
Time frame: 12 time points up to Day 60 of Follow-up
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Urelumab
Time frame: 12 time points up to Day 60 of Follow-up
Trough observed serum concentration (Cmin) of Urelumab and Rituximab
Time frame: 12 + 9 time points up to Day 60 of Follow-up
Area under the concentration-time curve (AUC) in one dosing interval (AUC(TAU)) of Urelumab
Time frame: 12 time points up to Day 60 of Follow-up
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University Of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
University Of Michigan Health System
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 5 more locations
Immunogenicity of Urelumab in combination with Rituximab as determined by blood sample measurements of anti-drug antibodies (ADA)
Time frame: Up to approximately 110 days post study drug