The purpose of this study is to determine whether ublituximab in combination with lenalidomide (Revlimid®) is safe and effective in patients with B-Cell Lymphoid Malignancies who have relapsed or are refractory after CD20 directed antibody therapy.
The study was intended to be a Phase 1/2 study, however, the study was terminated early and the phase 2 portion was never initiated. A limited number of participants were enrolled in Phase 1 and no maximum tolerated dose (MTD) or Phase 2 dose was identified for the combination of ublituximab and lenalidomide. Thus, Phase 2 data and results are not available to be reported.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ublituximab is a novel monoclonal antibody targeting CD20
Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, United States
Maximum Tolerated Dose acceptable for participants
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Time frame: 4 weeks
Efficacy
Efficacy will include overall response rate and duration of response
Time frame: After 8 weeks and then every 12 weeks
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