Description:
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)
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)
Recruiting
Phase 2
Drug | Synonyms | Arms |
---|---|---|
Ublituximab | TG-1101 | ublituximab + umbralisib + venetoclax |
Umbralisib | TGR-1202 | ublituximab + umbralisib + venetoclax |
Venetoclax | Venclexta | ublituximab + umbralisib + venetoclax |
This is an open-label, multicenter, Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with Chronic Lymphocytic Leukemia.
Name | Type | Description | Interventions |
---|---|---|---|
ublituximab + umbralisib + venetoclax | Experimental | ublituximab: 900 mg; to be administered through cycle 6 only umbralisib: 800 mg; to be administered daily venetoclax: to begin at cycle 4 (dose ramp-up schedule) and continue through cycle 24 |
|
Inclusion Criteria: - Chronic Lymphocytic Leukemia (CLL) that warrants treatment - Adequate organ system function as specified in the protocol - Ability to follow protocol procedures. Exclusion Criteria: - Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1. - Autologous hematologic stem cell transplant within 6 months of study entry. Prior. Allogeneic hematologic stem cell transplant is excluded. - Active Hepatitis B or Hepatitis C.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Overall Response Rate |
Time Frame: | Up to 12 months |
Safety Issue: | |
Description: | Objective response in subjects treated with ublituximab + umbralisib + venetoclax |
Measure: | Adverse Events That Are Related to Treatment |
Time Frame: | 6 months of therapy |
Safety Issue: | |
Description: | Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | TG Therapeutics, Inc. |
February 10, 2020