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Brief Title: Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Official Title: A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Study ID: NCT02301156
Brief Summary: This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.
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, Tucson, Arizona, United States
TG Therapeutics Investigational Trial Site, Fayetteville, Arkansas, United States
TG Therapeutics Investigational Trial Site, Jonesboro, Arkansas, United States
TG Therapeutics Investigational Trial Site, Fullerton, California, United States
TG Therapeutics Investigational Trial Site, Greenbrae, California, United States
TG Therapeutics Investigational Trial Site, Los Angeles, 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, Santa Barbara, California, United States
TG Therapeutics Investigational Trial Site, Aurora, Colorado, United States
TG Therapeutics Investigational Trial Site, Bridgeport, 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, Orange City, 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, West Palm Beach, Florida, United States
TG Therapeutics Investigational Trial Site, Albany, Georgia, United States
TG Therapeutics Investigational Trial Site, Newnan, Georgia, United States
TG Therapeutics Investigational Trial Site, Evanston, 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, 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, Westwood, Kansas, United States
TG Therapeutics Investigational Trial Site, Baton Rouge, Louisiana, United States
TG Therapeutics Investigational Trial Site, New Orleans, Louisiana, 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, Salisbury, Maryland, United States
TG Therapeutics Investigational Trial Site, Boston, Massachusetts, United States
TG Therapeutics Investigational Trial Site, Springfield, Massachusetts, United States
TG Therapeutics Investigational Trial Site, Worcester, Massachusetts, United States
TG Therapeutics Investigational Trial Site, Detroit, Michigan, United States
TG Therapeutics Investigational Trial Site, Coon Rapids, Minnesota, United States
TG Therapeutics Investigational Trial Site, Saint Louis Park, Minnesota, United States
TG Therapeutics Investigational Trial Site, Lincoln, Nebraska, 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, East Brunswick, New Jersey, United States
TG Therapeutics Investigational Trial Site, Howell, New Jersey, United States
TG Therapeutics Investigational Trial Site, Morristown, New Jersey, United States
TG Therapeutics Investigational Trial Site, Pompton Plains, New Jersey, United States
TG Therapeutics Investigational Trial Site, Somerville, New Jersey, United States
TG Therapeutics Investigational Trial Site, New York, 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, Raleigh, 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, Cleveland, 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, Philadelphia, 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, 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, Memphis, 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, Dallas, Texas, United States
TG Therapeutics Investigational Trial Site, Denton, Texas, United States
TG Therapeutics Investigational Trial Site, Fort Sam Houston, 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, Webster, 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, Richmond, Virginia, 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, Ashkelon, , Israel
Name: Jeff Sharman, MD
Affiliation: Willamette Valley Cancer Institute
Role: STUDY_CHAIR