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)

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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 participants with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL).

View Eligibility Criteria

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.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

277

Study ID:

NCT03801525

Recruitment Status:

Terminated

Sponsor:

TG Therapeutics, Inc.

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There are 50 Locations for this study

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TG Therapeutics Investigational Trial Site
Birmingham Alabama, 35294, United States
TG Therapeutics Investigational Trial Site
Huntsville Alabama, 35805, United States
TG Therapeutics Investigational Trial Site
Tucson Arizona, 85711, United States
TG Therapeutics Investigational Trial Site
Duarte California, 91010, United States
TG Therapeutics Investigational Trial Site
La Jolla California, 92093, United States
TG Therapeutics Investigational Trial Site
Aurora Colorado, 80012, United States
TG Therapeutics Investigational Trial Site
Stamford Connecticut, 06904, United States
TG Therapeutics Investigational Trial Site
Boca Raton Florida, 33486, United States
TG Therapeutics Investigational Trial Site
Fort Myers Florida, 33901, United States
TG Therapeutics Investigational Trial Site
Jacksonville Florida, 32224, United States
TG Therapeutics Investigational Trial Site
Saint Petersburg Florida, 33705, United States
TG Therapeutics Investigational Trial Site
Tampa Florida, 33612, United States
TG Therapeutics Investigational Trial Site
Atlanta Georgia, 30322, United States
TG Therapeutics Investigational Trial Site
Decatur Illinois, 62526, United States
TG Therapeutics Investigational Trial Site
Niles Illinois, 60714, United States
TG Therapeutics Investigational Site
Peoria Illinois, 61615, United States
TG Therapeutics Investigational Trial Site
Fort Wayne Indiana, 46804, United States
TG Therapeutics Investigational Trial Site
Indianapolis Indiana, 46237, United States
TG Therapeutics Investigational Trial Site
Des Moines Iowa, 50309, United States
TG Therapeutics Investigational Trial Site
Westwood Kansas, 66210, United States
TG Therapeutics Investigational Site
Louisville Kentucky, 40207, United States
TG Therapeutics Investigational Trial Site
Bethesda Maryland, 37210, United States
TG Therapeutics Investigational Trial Site
Columbia Maryland, 21044, United States
TG Therapeutics Investigational Trial Site
Ann Arbor Michigan, 48197, United States
TG Therapeutics Investigational Trial Site
Detroit Michigan, 48201, United States
TG Therapeutics Investigational Trial Site
Detroit Michigan, 48202, United States
TG Therapeutics Investigational Trial Site
Rochester Minnesota, 55905, United States
TG Therapeutics Investigational Trial Site
Omaha Nebraska, 68198, United States
TG Therapeutics Investigational Trial Site
Lebanon New Hampshire, 03756, United States
TG Therapeutics Investigational Trial Site
Hackensack New Jersey, 07601, United States
TG Therapeutics Investigational Trial Site
Morristown New Jersey, 07960, United States
TG Therapeutics Investigational Trial Site
New York New York, 10065, United States
TG Therapeutics Investigational Trial Site
Charlotte North Carolina, 28204, United States
TG Therapeutics Investigational Trial Site
Columbus Ohio, 43210, United States
TG Therapeutics Investigational Trial Site
Eugene Oregon, 97401, United States
TG Therapeutics Investigational Trial Site
Philadelphia Pennsylvania, 19106, United States
TG Therapeutics Investigational Trial Site
Charleston South Carolina, 29414, United States
TG Therapeutics Investigational Trial Site
Greenville South Carolina, 29616, United States
TG Therapeutics Investigational Trial Site
Chattanooga Tennessee, 37404, United States
TG Therapeutics Investigational Trial Site
Knoxville Tennessee, 37916, United States
TG Therapeutics Investigational Trial Site
Nashville Tennessee, 37203, United States
TG Therapeutics Investigational Trial Site
Austin Texas, 78705, United States
TG Therapeutics Investigational Trial Site
San Antonio Texas, 78229, United States
TG Therapeutics Investigational Trial Site
Tyler Texas, 75702, United States
TG Therapeutics Investigational Trial Site
Ogden Utah, 84405, United States
TG Therapeutics Investigational Trial Site
Salt Lake City Utah, 84106, United States
TG Therapeutics Investigational Trial Site
Blacksburg Virginia, 24060, United States
TG Therapeutics Investigational Trial Site
Gainesville Virginia, 20155, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98104, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98108, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

277

Study ID:

NCT03801525

Recruitment Status:

Terminated

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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