Chronic Lymphocytic Leukemia Clinical Trial
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)
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 (leukemia-cll/" >CLL)
Full 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 patients with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL)
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 50 Locations for this study
Birmingham Alabama, 35294, United States
Huntsville Alabama, 35805, United States
Tucson Arizona, 85711, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Aurora Colorado, 80012, United States
Stamford Connecticut, 06904, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32224, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Decatur Illinois, 62526, United States
Niles Illinois, 60714, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46237, United States
Des Moines Iowa, 50309, United States
Westwood Kansas, 66210, United States
Louisville Kentucky, 40207, United States
Bethesda Maryland, 37210, United States
Columbia Maryland, 21044, United States
Ann Arbor Michigan, 48197, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68198, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07960, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Columbus Ohio, 43210, United States
Eugene Oregon, 97401, United States
Philadelphia Pennsylvania, 19106, United States
Charleston South Carolina, 29414, United States
Greenville South Carolina, 29616, United States
Chattanooga Tennessee, 37404, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
San Antonio Texas, 78229, United States
Tyler Texas, 75702, United States
Ogden Utah, 84405, United States
Salt Lake City Utah, 84106, United States
Blacksburg Virginia, 24060, United States
Gainesville Virginia, 20155, United States
Seattle Washington, 98104, United States
Seattle Washington, 98108, United States
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