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ULTRA-V: Phase 2 Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) in Subjects with Chronic Lymphocytic Leukemia (CLL)
This is a Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with CLL.
PRIMARY OBJECTIVES To determine the Complete Response (CR) rate of the combination of ublituximab, umbralisib, and venetoclax To determine the Overall Response Rate (ORR) of the combination of ublituximab, umbralisib, and venetoclax SECONDARY OBJECTIVES To determine the rate of MRD negativity To determine Time to Response (TTR), Duration of response (DOR), and Progression-Free survival (PFS) To characterize the safety of the combination regimen
GDC-0199 (Venetoclax); Ublituximab (); Umbralisib (); Venetoclax ()