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)
Stopped early · Phase 2/Phase 3
Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
In brief
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 Leukemia (CLL)
Key facts
- Study ID
- NCT03801525
- Run by
- TG Therapeutics, Inc.
- People needed
- 277
- Starts
- 2019-05-16
- Expected to finish
- 2022-12-20
- Last updated by the study team
- 2024-04-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- TG Therapeutics Investigational Trial Site — Birmingham, Alabama, United States
- TG Therapeutics Investigational Trial Site — Huntsville, Alabama, United States
- TG Therapeutics Investigational Trial Site — Tucson, Arizona, United States
- TG Therapeutics Investigational Trial Site — Duarte, California, United States
- TG Therapeutics Investigational Trial Site — La Jolla, California, United States
- TG Therapeutics Investigational Trial Site — Aurora, Colorado, United States
- TG Therapeutics Investigational Trial Site — Stamford, Connecticut, United States
- TG Therapeutics Investigational Trial Site — Boca Raton, Florida, United States
- TG Therapeutics Investigational Trial Site — Fort Myers, Florida, United States
- TG Therapeutics Investigational Trial Site — Jacksonville, Florida, United States
- TG Therapeutics Investigational Trial Site — St. Petersburg, Florida, United States
- TG Therapeutics Investigational Trial Site — Tampa, Florida, United States
- TG Therapeutics Investigational Trial Site — Atlanta, Georgia, United States
- TG Therapeutics Investigational Trial Site — Decatur, Illinois, United States
- TG Therapeutics Investigational Trial Site — Niles, Illinois, United States
- TG Therapeutics Investigational Site — Peoria, Illinois, United States
- TG Therapeutics Investigational Trial Site — Fort Wayne, Indiana, United States
- TG Therapeutics Investigational Trial Site — Indianapolis, Indiana, United States
- TG Therapeutics Investigational Trial Site — Des Moines, Iowa, United States
- TG Therapeutics Investigational Trial Site — Westwood, Kansas, United States
- TG Therapeutics Investigational Site — Louisville, Kentucky, United States
- TG Therapeutics Investigational Trial Site — Bethesda, Maryland, United States
- TG Therapeutics Investigational Trial Site — Columbia, Maryland, United States
- TG Therapeutics Investigational Trial Site — Ann Arbor, Michigan, United States
- TG Therapeutics Investigational Trial Site — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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