The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Jonesboro, Arkansas, United States
TG Therapeutics Investigational Trial Site
Athens, Georgia, United States
TG Therapeutics Investigational Trial Site
Macon, Georgia, United States
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, United States
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, United States
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Time frame: Subjects will be followed for 4 weeks
Maximum Tolerated Dose acceptable for participants
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Time frame: Subjects will be followed for 4 weeks
Efficacy
Efficacy will include overall response rate, duration of response and progression-free survival
Time frame: Participants will be evaluated approximately every 8 - 12 weeks
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