Status:
TERMINATED
Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Le...
Detailed Description
This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + ...
Eligibility Criteria
Inclusion
- Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment
- Adequate organ system function as specified in the protocol
- Ability to follow protocol procedures.
Exclusion
- Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1
- Prior exposure to any PI3K inhibitor or venetoclax
- 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.
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT03801525
Start Date
May 16 2019
End Date
December 20 2022
Last Update
April 19 2024
Active Locations (50)
Enter a location and click search to find clinical trials sorted by distance.
1
TG Therapeutics Investigational Trial Site
Birmingham, Alabama, United States, 35294
2
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
3
TG Therapeutics Investigational Trial Site
Tucson, Arizona, United States, 85711
4
TG Therapeutics Investigational Trial Site
Duarte, California, United States, 91010