Chronic Lymphocytic Leukemia Clinical Trial
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
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 (leukemia-cll/" >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.
Eligibility Criteria
Inclusion Criteria:
Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria:
Any major surgery, chemotherapy or immunotherapy within the last 21 days
Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
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There are 87 Locations for this study
Huntsville Alabama, 35805, United States
Mobile Alabama, 36604, United States
Chandler Arizona, 85224, United States
Tucson Arizona, 85710, United States
Fayetteville Arkansas, 72703, United States
Jonesboro Arkansas, 72401, United States
Fullerton California, 92835, United States
Greenbrae California, 94904, United States
Los Angeles California, 90045, United States
Pismo Beach California, 93449, United States
Pleasanton California, 94588, United States
Santa Barbara California, 93105, United States
Aurora Colorado, 80012, United States
Bridgeport Connecticut, 06606, United States
Stamford Connecticut, 06904, United States
Newark Delaware, 19173, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33905, United States
Orange City Florida, 32763, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33709, United States
West Palm Beach Florida, 33401, United States
Albany Georgia, 31701, United States
Newnan Georgia, 30265, United States
Evanston Illinois, 60201, United States
Maywood Illinois, 60153, United States
Niles Illinois, 60714, United States
Urbana Illinois, 61801, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46237, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52403, United States
Westwood Kansas, 66205, United States
Baton Rouge Louisiana, 70816, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21202, United States
Baltimore Maryland, 21215, United States
Bethesda Maryland, 20817, United States
Columbia Maryland, 21044, United States
Salisbury Maryland, 21801, United States
Boston Massachusetts, 02111, United States
Springfield Massachusetts, 01199, United States
Worcester Massachusetts, 01608, United States
Detroit Michigan, 48202, United States
Coon Rapids Minnesota, 55433, United States
Saint Louis Park Minnesota, 55416, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68130, United States
Lebanon New Hampshire, 03756, United States
East Brunswick New Jersey, 08816, United States
Howell New Jersey, 07731, United States
Morristown New Jersey, 07962, United States
Pompton Plains New Jersey, 07444, United States
Somerville New Jersey, 08876, United States
New York New York, 10019, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Raleigh North Carolina, 27607, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97213, United States
Portland Oregon, 97227, United States
Springfield Oregon, 97477, United States
Camp Hill Pennsylvania, 17011, United States
Philadelphia Pennsylvania, 19104, United States
Pawtucket Rhode Island, 02860, United States
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Watertown South Dakota, 57201, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Dallas Texas, 75230, United States
Denton Texas, 76201, United States
Fort Sam Houston Texas, 78234, United States
San Antonio Texas, 78229, United States
Tyler Texas, 75702, United States
Webster Texas, 77598, United States
Ogden Utah, 84403, United States
Blacksburg Virginia, 24060, United States
Richmond Virginia, 23230, United States
Seattle Washington, 98104, United States
Spokane Washington, 99216, United States
Vancouver Washington, 98683, United States
Ashkelon , , Israel
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