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Brief Title: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Official Title: Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Study ID: NCT02612311
Brief Summary: This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
TG Therapeutics Investigational Trial Site, Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site, Mobile, Alabama, United States
TG Therapeutics Investigational Trial Site, Chandler, Arizona, United States
TG Therapeutics Investigational Trial Site, Phoenix, Arizona, United States
TG Therapeutics Investigational Trial Site, Tucson, Arizona, United States
TG Therapeutics Investigational Trial Site, Fayetteville, Arkansas, United States
TG Therapeutics Investigational Trial Site, Concord, California, United States
TG Therapeutics Investigational Trial Site, Duarte, California, United States
TG Therapeutics Investigational Trial Site, Greenbrae, California, United States
TG Therapeutics Investigational Trial Site, Pismo Beach, California, United States
TG Therapeutics Investigational Trial Site, Pleasanton, California, United States
TG Therapeutics Investigational Trial Site, San Diego, California, United States
TG Therapeutics Investigational Trial Site, Santa Barbara, California, United States
TG Therapeutics Investigational Trial Site, Whittier, California, United States
TG Therapeutics Investigational Trial Site, Aurora, Colorado, United States
TG Therapeutics Investigational Trial Site, Denver, Colorado, United States
TG Therapeutics Investigational Trial Site, Bridgeport, Connecticut, United States
TG Therapeutics Investigational Trial Site, New Haven, Connecticut, United States
TG Therapeutics Investigational Trial Site, Stamford, Connecticut, United States
TG Therapeutics Investigational Trial Site, Newark, Delaware, 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, Jacksonville, Florida, United States
TG Therapeutics Investigational Trial Site, Ocala, Florida, United States
TG Therapeutics Investigational Trial Site, Pensacola, Florida, United States
TG Therapeutics Investigational Trial Site, Saint Petersburg, Florida, United States
TG Therapeutics Investigational Trial Site, Tallahassee, Florida, United States
TG Therapeutics Investigational Trial Site, Tampa, Florida, United States
TG Therapeutics Investigational Trial Site, West Palm Beach, Florida, United States
TG Therapeutics Investigational Trial Site, Albany, Georgia, United States
TG Therapeutics Investigational Trial Site, Macon, Georgia, United States
TG Therapeutics Investigational Trial Site, Chicago, Illinois, United States
TG Therapeutics Investigational Trial Site, Decatur, Illinois, United States
TG Therapeutics Investigational Trial Site, Maywood, Illinois, United States
TG Therapeutics Investigational Trial Site, Niles, Illinois, United States
TG Therapeutics Investigational Trial Site, Peoria, Illinois, United States
TG Therapeutics Investigational Trial Site, Swansea, Illinois, United States
TG Therapeutics Investigational Trial Site, Urbana, 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, Ames, Iowa, United States
TG Therapeutics Investigational Trial Site, Cedar Rapids, Iowa, United States
TG Therapeutics Investigational Trial Site, Kansas City, Kansas, United States
TG Therapeutics Investigational Trial Site, Westwood, Kansas, United States
TG Therapeutics Investigational Trial Site, Louisville, Kentucky, United States
TG Therapeutics Investigational Trial Site, Baltimore, Maryland, United States
TG Therapeutics Investigational Trial Site, Baltimore, Maryland, 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, Boston, Massachusetts, United States
TG Therapeutics Investigational Trial Site, Worcester, Massachusetts, 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, Jackson, Michigan, United States
TG Therapeutics Investigational Trial Site, Saint Louis Park, Minnesota, United States
TG Therapeutics Investigational Trial Site, Columbia, Missouri, United States
TG Therapeutics Investigational Trial Site, Kansas City, Missouri, United States
TG Therapeutics Investigational Trial Site, Lincoln, Nebraska, United States
TG Therapeutics Investigational Trial Site, Las Vegas, Nevada, United States
TG Therapeutics Investigational Trial Site, Lebanon, New Hampshire, United States
TG Therapeutics Investigational Trial Site, Morristown, New Jersey, United States
TG Therapeutics Investigational Trial Site, Somerville, New Jersey, United States
TG Therapeutics Investigational Trial Site, East Setauket, New York, United States
TG Therapeutics Investigational Trial Site, Glens Falls, New York, United States
TG Therapeutics Investigational Trial Site, Syracuse, New York, United States
TG Therapeutics Investigational Trial Site, Charlotte, North Carolina, United States
TG Therapeutics Investigational Trial Site, Durham, North Carolina, United States
TG Therapeutics Investigational Trial Site, Durham, North Carolina, United States
TG Therapeutics Investigational Trial Site, Hickory, North Carolina, United States
TG Therapeutics Investigational Trial Site, Kinston, North Carolina, United States
TG Therapeutics Investigational Trial Site, Raleigh, North Carolina, United States
TG Therapeutics Investigational Trial Site, Washington, North Carolina, United States
TG Therapeutics Investigational Trial Site, Canton, Ohio, United States
TG Therapeutics Investigational Trial Site, Cincinnati, Ohio, United States
TG Therapeutics Investigational Trial Site, Toledo, Ohio, United States
TG Therapeutics Investigational Trial Site, Portland, Oregon, United States
TG Therapeutics Investigational Trial Site, Portland, Oregon, United States
TG Therapeutics Investigational Trial Site, Springfield, Oregon, United States
TG Therapeutics Investigational Trial Site, Camp Hill, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Danville, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Hershey, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Philadelphia, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Pittsburgh, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Pittsburgh, Pennsylvania, United States
TG Therapeutics Investigational Trial Site, Pawtucket, Rhode Island, United States
TG Therapeutics Investigational Trial Site, Greenville, South Carolina, United States
TG Therapeutics Investigational Trial Site, Sioux Falls, South Dakota, United States
TG Therapeutics Investigational Trial Site, Watertown, South Dakota, United States
TG Therapeutics Investigational Trial Site, Chattanooga, 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, Bedford, Texas, United States
TG Therapeutics Investigational Trial Site, Fort Worth, Texas, United States
TG Therapeutics Investigational Trial Site, Houston, Texas, United States
TG Therapeutics Investigational Trial Site, San Antonio, 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, Blacksburg, Virginia, United States
TG Therapeutics Investigational Trial Site, Charlottesville, Virginia, United States
TG Therapeutics Investigational Trial Site, Fort Belvoir, Virginia, United States
TG Therapeutics Investigational Trial Site, Olympia, Washington, United States
TG Therapeutics Investigational Trial Site, Seattle, Washington, United States
TG Therapeutics Investigational Trial Site, Seattle, Washington, United States
TG Therapeutics Investigational Trial Site, Spokane, Washington, United States
TG Therapeutics Investigational Trial Site, Vancouver, Washington, United States
TG Therapeutics Investigational Trial Site, Yakima, Washington, United States
TG Therapeutics Investigational Trial Site, Milwaukee, Wisconsin, United States
TG Therapeutics Investigational Trial Site, Wauwatosa, Wisconsin, United States
TG Therapeutics Investigational Trial Site, Ashkelon, , Israel
TG Therapeutics Investigational Trial Site, Be'er Sheva, , Israel
TG Therapeutics Investigational Trial Site, Haifa, , Israel
TG Therapeutics Investigational Trial Site, Jerusalem, , Israel
TG Therapeutics Investigational Trial Site, Nahariya, , Israel
TG Therapeutics Investigational Trial Site, Petah tikva, , Israel
TG Therapeutics Investigational Trial Site, Tel Aviv, , Israel
TG Therapeutics Investigational Trial Site, Bologna, , Italy
TG Therapeutics Investigational Trial Site, Ferrara, , Italy
TG Therapeutics Investigational Trial Site, Milan, , Italy
TG Therapeutics Investigational Trial Site, Rome, , Italy
TG Therapeutics Investigational Trial Site, Torino, , Italy
TG Therapeutics Investigational Trial Site, Chorzów, , Poland
TG Therapeutics Investigational Trial Site, Gdynia, , Poland
TG Therapeutics Investigational Trial Site, Krakow, , Poland
TG Therapeutics Investigational Trial Site, Lublin, , Poland
TG Therapeutics Investigational Trial Site, Słupsk, , Poland
TG Therapeutics Investigational Trial Site, Warszawa, , Poland
TG Therapeutics Investigational Trial Site, Wroclaw, , Poland
TG Therapeutics Investigational Trial Site, Łódź, , Poland
TG Therapeutics Investigational Trial Site, Krasnozatonskiy, , Russian Federation
TG Therapeutics Investigational Trial Site, Moscow, , Russian Federation
TG Therapeutics Investigational Trial Site, Perm, , Russian Federation
TG Therapeutics Investigational Trial Site, Petrozavodsk, , Russian Federation
TG Therapeutics Investigational Trial Site, Rodionova, , Russian Federation
TG Therapeutics Investigational Trial Site, Saint Petersburg, , Russian Federation
TG Therapeutics Investigational Trial Site, Smolensk, , Russian Federation
TG Therapeutics Investigational Trial Site, Tula, , Russian Federation
TG Therapeutics Investigational Trial Site, Yaroslavl, , Russian Federation
TG Therapeutics Investigational Trial Site, Barcelona, , Spain
TG Therapeutics Investigational Trial Site, Madrid, , Spain
TG Therapeutics Investigational Trial Site, Valencia, , Spain
TG Therapeutics Investigational Trial Site, Cambridge, , United Kingdom
TG Therapeutics Investigational Trial Site, Cumbria, , United Kingdom
TG Therapeutics Investigational Trial Site, Dudley West, , United Kingdom
TG Therapeutics Investigational Trial Site, London, , United Kingdom
TG Therapeutics Investigational Trial Site, Northbrook, , United Kingdom
TG Therapeutics Investigational Trial Site, Northumbria, , United Kingdom
TG Therapeutics Investigational Trial Site, Norwich, , United Kingdom
TG Therapeutics Investigational Trial Site, Peterborough, , United Kingdom
TG Therapeutics Investigational Trial Site, Southampton, , United Kingdom
TG Therapeutics Investigational Trial Site, St. James, , United Kingdom
TG Therapeutics Investigational Trial Site, Sunderland, , United Kingdom
TG Therapeutics Investigational Trial Site, Wolverhampton, , United Kingdom