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.

View Eligibility Criteria

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)

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

126

Study ID:

NCT02301156

Recruitment Status:

Completed

Sponsor:

TG Therapeutics, Inc.

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There are 87 Locations for this study

See Locations Near You

TG Therapeutics Investigational Trial Site
Huntsville Alabama, 35805, United States
TG Therapeutics Investigational Trial Site
Mobile Alabama, 36604, United States
TG Therapeutics Investigational Trial Site
Chandler Arizona, 85224, United States
TG Therapeutics Investigational Trial Site
Tucson Arizona, 85710, United States
TG Therapeutics Investigational Trial Site
Fayetteville Arkansas, 72703, United States
TG Therapeutics Investigational Trial Site
Jonesboro Arkansas, 72401, United States
TG Therapeutics Investigational Trial Site
Fullerton California, 92835, United States
TG Therapeutics Investigational Trial Site
Greenbrae California, 94904, United States
TG Therapeutics Investigational Trial Site
Los Angeles California, 90045, United States
TG Therapeutics Investigational Trial Site
Pismo Beach California, 93449, United States
TG Therapeutics Investigational Trial Site
Pleasanton California, 94588, United States
TG Therapeutics Investigational Trial Site
Santa Barbara California, 93105, United States
TG Therapeutics Investigational Trial Site
Aurora Colorado, 80012, United States
TG Therapeutics Investigational Trial Site
Bridgeport Connecticut, 06606, United States
TG Therapeutics Investigational Trial Site
Stamford Connecticut, 06904, United States
TG Therapeutics Investigational Trial Site
Newark Delaware, 19173, United States
TG Therapeutics Investigational Trial Site
Boca Raton Florida, 33486, United States
TG Therapeutics Investigational Trial Site
Fort Myers Florida, 33905, United States
TG Therapeutics Investigational Trial Site
Orange City Florida, 32763, United States
TG Therapeutics Investigational Trial Site
Pensacola Florida, 32504, United States
TG Therapeutics Investigational Trial Site
Saint Petersburg Florida, 33709, United States
TG Therapeutics Investigational Trial Site
West Palm Beach Florida, 33401, United States
TG Therapeutics Investigational Trial Site
Albany Georgia, 31701, United States
TG Therapeutics Investigational Trial Site
Newnan Georgia, 30265, United States
TG Therapeutics Investigational Trial Site
Evanston Illinois, 60201, United States
TG Therapeutics Investigational Trial Site
Maywood Illinois, 60153, United States
TG Therapeutics Investigational Trial Site
Niles Illinois, 60714, United States
TG Therapeutics Investigational Trial Site
Urbana Illinois, 61801, 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
Ames Iowa, 50010, United States
TG Therapeutics Investigational Trial Site
Cedar Rapids Iowa, 52403, United States
TG Therapeutics Investigational Trial Site
Westwood Kansas, 66205, United States
TG Therapeutics Investigational Trial Site
Baton Rouge Louisiana, 70816, United States
TG Therapeutics Investigational Trial Site
New Orleans Louisiana, 70121, United States
TG Therapeutics Investigational Trial Site
Baltimore Maryland, 21202, United States
TG Therapeutics Investigational Trial Site
Baltimore Maryland, 21215, United States
TG Therapeutics Investigational Trial Site
Bethesda Maryland, 20817, United States
TG Therapeutics Investigational Trial Site
Columbia Maryland, 21044, United States
TG Therapeutics Investigational Trial Site
Salisbury Maryland, 21801, United States
TG Therapeutics Investigational Trial Site
Boston Massachusetts, 02111, United States
TG Therapeutics Investigational Trial Site
Springfield Massachusetts, 01199, United States
TG Therapeutics Investigational Trial Site
Worcester Massachusetts, 01608, United States
TG Therapeutics Investigational Trial Site
Detroit Michigan, 48202, United States
TG Therapeutics Investigational Trial Site
Coon Rapids Minnesota, 55433, United States
TG Therapeutics Investigational Trial Site
Saint Louis Park Minnesota, 55416, United States
TG Therapeutics Investigational Trial Site
Lincoln Nebraska, 68510, United States
TG Therapeutics Investigational Trial Site
Omaha Nebraska, 68130, United States
TG Therapeutics Investigational Trial Site
Lebanon New Hampshire, 03756, United States
TG Therapeutics Investigational Trial Site
East Brunswick New Jersey, 08816, United States
TG Therapeutics Investigational Trial Site
Howell New Jersey, 07731, United States
TG Therapeutics Investigational Trial Site
Morristown New Jersey, 07962, United States
TG Therapeutics Investigational Trial Site
Pompton Plains New Jersey, 07444, United States
TG Therapeutics Investigational Trial Site
Somerville New Jersey, 08876, United States
TG Therapeutics Investigational Trial Site
New York New York, 10019, United States
TG Therapeutics Investigational Trial Site
Syracuse New York, 13210, United States
TG Therapeutics Investigational Trial Site
Charlotte North Carolina, 28204, United States
TG Therapeutics Investigational Trial Site
Durham North Carolina, 27710, United States
TG Therapeutics Investigational Trial Site
Raleigh North Carolina, 27607, United States
TG Therapeutics Investigational Trial Site
Canton Ohio, 44718, United States
TG Therapeutics Investigational Trial Site
Cincinnati Ohio, 45242, United States
TG Therapeutics Investigational Trial Site
Cleveland Ohio, 44106, United States
TG Therapeutics Investigational Trial Site
Portland Oregon, 97213, United States
TG Therapeutics Investigational Trial Site
Portland Oregon, 97227, United States
TG Therapeutics Investigational Trial Site
Springfield Oregon, 97477, United States
TG Therapeutics Investigational Trial Site
Camp Hill Pennsylvania, 17011, United States
TG Therapeutics Investigational Trial Site
Philadelphia Pennsylvania, 19104, United States
TG Therapeutics Investigational Trial Site
Pawtucket Rhode Island, 02860, United States
TG Therapeutics Investigational Trial Site
Greenville South Carolina, 29607, United States
TG Therapeutics Investigational Trial Site
Greenville South Carolina, 29615, United States
TG Therapeutics Investigational Trial Site
Sioux Falls South Dakota, 57105, United States
TG Therapeutics Investigational Trial Site
Watertown South Dakota, 57201, United States
TG Therapeutics Investigational Trial Site
Memphis Tennessee, 38120, 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
Dallas Texas, 75230, United States
TG Therapeutics Investigational Trial Site
Denton Texas, 76201, United States
TG Therapeutics Investigational Trial Site
Fort Sam Houston Texas, 78234, 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
Webster Texas, 77598, United States
TG Therapeutics Investigational Trial Site
Ogden Utah, 84403, United States
TG Therapeutics Investigational Trial Site
Blacksburg Virginia, 24060, United States
TG Therapeutics Investigational Trial Site
Richmond Virginia, 23230, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98104, United States
TG Therapeutics Investigational Trial Site
Spokane Washington, 99216, United States
TG Therapeutics Investigational Trial Site
Vancouver Washington, 98683, United States
TG Therapeutics Investigational Trial Site
Ashkelon , , Israel

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

126

Study ID:

NCT02301156

Recruitment Status:

Completed

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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