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Brief Title: 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)
Official Title: Phase 2/3 Randomized 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)
Study ID: NCT03801525
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 Leukemia (CLL)
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 + umbralisib (U2) in participants with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Saint 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
TG Therapeutics Investigational Trial Site, Detroit, Michigan, United States
TG Therapeutics Investigational Trial Site, Rochester, Minnesota, United States
TG Therapeutics Investigational Trial Site, Omaha, Nebraska, United States
TG Therapeutics Investigational Trial Site, Lebanon, New Hampshire, United States
TG Therapeutics Investigational Trial Site, Hackensack, New Jersey, United States
TG Therapeutics Investigational Trial Site, Morristown, New Jersey, United States
TG Therapeutics Investigational Trial Site, New York, New York, United States
TG Therapeutics Investigational Trial Site, Charlotte, North Carolina, United States
TG Therapeutics Investigational Trial Site, Columbus, Ohio, United States
TG Therapeutics Investigational Trial Site, Eugene, Oregon, United States
TG Therapeutics Investigational Trial Site, Philadelphia, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Charleston, South Carolina, United States
TG Therapeutics Investigational Trial Site, Greenville, South Carolina, United States
TG Therapeutics Investigational Trial Site, Chattanooga, Tennessee, United States
TG Therapeutics Investigational Trial Site, Knoxville, Tennessee, United States
TG Therapeutics Investigational Trial Site, Nashville, Tennessee, United States
TG Therapeutics Investigational Trial Site, Austin, Texas, United States
TG Therapeutics Investigational Trial Site, San Antonio, Texas, United States
TG Therapeutics Investigational Trial Site, Tyler, Texas, United States
TG Therapeutics Investigational Trial Site, Ogden, Utah, United States
TG Therapeutics Investigational Trial Site, Salt Lake City, Utah, United States
TG Therapeutics Investigational Trial Site, Blacksburg, Virginia, United States
TG Therapeutics Investigational Trial Site, Gainesville, Virginia, United States
TG Therapeutics Investigational Trial Site, Seattle, Washington, United States
TG Therapeutics Investigational Trial Site, Seattle, Washington, United States