Non Hodgkin Lymphoma Clinical Trial

Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

Summary

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

View Full Description

Full Description

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

Exclusion Criteria:

Any major surgery, chemotherapy or immunotherapy within the last 21 days
Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
Prior therapy with a PI3K delta inhibitor

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

710

Study ID:

NCT02793583

Recruitment Status:

Terminated

Sponsor:

TG Therapeutics, Inc.

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There are 167 Locations for this study

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TG Therapeutics Investigational Trial Site
Birmingham Alabama, 35243, United States
TG Therapeutics Investigational Trial Site
Huntsville Alabama, 35805, United States
TG Therapeutics Investigational Trial Site
Chandler Arizona, 85224, United States
TG Therapeutics Investigational Trial Site
Tucson Arizona, 85711, United States
TG Therapeutics Investigational Trial Site
Tucson Arizona, 85724, United States
TG Therapeutics Investigational Trial Site
Los Angeles California, 90095, United States
TG Therapeutics Investigational Trial Site
Orange California, 92868, United States
TG Therapeutics Investigational Trial Site
San Diego California, 90710, United States
TG Therapeutics Investigational Trial Site
San Diego California, 92108, United States
TG Therapeutics Investigational Trial Site
Whittier California, 90603, United States
TG Therapeutics Investigational Trial Site
Aurora Colorado, 80012, United States
TG Therapeutics Investigational Trial Site
Denver Colorado, 80218, United States
TG Therapeutics Investigational Trial Site
Fort Collins Colorado, 80528, United States
TG Therapeutics Investigational Trial Site
Bridgeport Connecticut, 06606, United States
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Newark Delaware, 19713, United States
TG Therapeutics Investigational Trial Site
Washington District of Columbia, 20007, United States
TG Therapeutics Investigational Trial Site
Boca Raton Florida, 33486, United States
TG Therapeutics Investigational Trial Site
Fort Myers Florida, 33916, United States
TG Therapeutics Investigational Trial Site
Gainesville Florida, 32608, United States
TG Therapeutics Investigational Trial Site
Jacksonville Florida, 32204, United States
TG Therapeutics Investigational Trial Site
Jacksonville Florida, 32224, United States
TG Therapeutics Investigational Trial Site
Jacksonville Florida, 32256, United States
TG Therapeutics Investigational Trial Site
Miami Florida, 33176, United States
TG Therapeutics Investigational Trial Site
Saint Petersburg Florida, 33705, United States
TG Therapeutics Investigational Trial Site
Tallahassee Florida, 32308, United States
TG Therapeutics Investigational Trial Site
Tampa Florida, 33612, United States
TG Therapeutics Investigational Trial Site
West Palm Beach Florida, 33407, United States
TG Therapeutics Investigational Trial Site
Albany Georgia, 31701, United States
TG Therapeutics Investigational Trial Site
Macon Georgia, 31201, United States
TG Therapeutics Investigational Trial Site
Marietta Georgia, 30060, United States
TG Therapeutics Investigational Trial Site
Chicago Illinois, 60612, United States
TG Therapeutics Investigational Trial Site
Chicago Illinois, 60637, United States
TG Therapeutics Investigational Trial Site
Decatur Illinois, 62526, United States
TG Therapeutics Investigational Trial Site
Evanston Illinois, 60201, United States
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Harvey Illinois, 60426, 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
Peoria Illinois, 61615, United States
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Swansea Illinois, 62226, United States
TG Therapeutics Investigational Trial Site
Fort Wayne Indiana, 46845, United States
TG Therapeutics Investigational Trial Site
Indianapolis Indiana, 46237, United States
TG Therapeutics Investigational Trial Site
Westwood Kansas, 66210, United States
TG Therapeutics Investigational Trial Site
Louisville Kentucky, 40207, United States
TG Therapeutics Investigational Trial Site
Covington Louisiana, 70433, United States
TG Therapeutics Investigational Trial Site
Brewer Maine, 04412, United States
TG Therapeutics Investigational Trial Site
Baltimore Maryland, 21201, 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
Towson Maryland, 21204, United States
TG Therapeutics Investigational Trial Site
Ann Arbor Michigan, 48109, United States
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Duluth Minnesota, 55805, United States
TG Therapeutics Investigational Trial Site
Saint Louis Park Minnesota, 55416, United States
TG Therapeutics Investigational Trial Site
Columbia Missouri, 65212, United States
TG Therapeutics Investigational Trial Site
Kansas City Missouri, 64132, United States
TG Therapeutics Investigational Trial Site
Saint Louis Missouri, 63110, United States
TG Therapeutics Investigational Trial Site
Billings Montana, 59102, 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
Hackensack New Jersey, 07601, United States
TG Therapeutics Investigational Trial Site
Morristown New Jersey, 07962, United States
TG Therapeutics Investigational Trial Site
Mount Holly New Jersey, 08060, United States
TG Therapeutics Investigational Trial Site
Farmington New Mexico, 87401, United States
TG Therapeutics Investigational Trial Site
Bronx New York, 10467, United States
TG Therapeutics Investigational Trial Site
Buffalo New York, 14263, 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, 28201, United States
TG Therapeutics Investigational Trial Site
Durham North Carolina, 27705, United States
TG Therapeutics Investigational Trial Site
Hickory North Carolina, 28602, United States
TG Therapeutics Investigational Trial Site
Kinston North Carolina, 28501, United States
TG Therapeutics Investigational Trial Site
Raleigh North Carolina, 27607, United States
TG Therapeutics Investigational Trial Site
Washington North Carolina, 27889, United States
TG Therapeutics Investigational Trial Site
Canton Ohio, 44718, United States
TG Therapeutics Investigational Trial Site
Cincinnati Ohio, 45220, 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
Columbus Ohio, 43219, United States
TG Therapeutics Investigational Trial Site
Toledo Ohio, 43623, 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, 19106, United States
TG Therapeutics Investigational Trial Site
Providence Rhode Island, 02906, 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
Chattanooga Tennessee, 37404, United States
TG Therapeutics Investigational Trial Site
Kingsport Tennessee, 37660, United States
TG Therapeutics Investigational Trial Site
Knoxville Tennessee, 37916, United States
TG Therapeutics Investigational Trial Site
Memphis Tennessee, 38120, United States
TG Therapeutics Investigational Trial Site
Austin Texas, 78705, United States
TG Therapeutics Investigational Trial Site
Dallas Texas, 75390, United States
TG Therapeutics Investigational Trial Site
Fort Sam Houston Texas, 78234, United States
TG Therapeutics Investigational Trial Site
Houston Texas, 77030, United States
TG Therapeutics Investigational Trial Site
San Antonio Texas, 78130, United States
TG Therapeutics Investigational Trial Site
San Antonio Texas, 78217, 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, 84403, United States
TG Therapeutics Investigational Trial Site
Blacksburg Virginia, 24060, United States
TG Therapeutics Investigational Trial Site
Newport News Virginia, 23601, United States
TG Therapeutics Investigational Trial Site
Olympia Washington, 98502, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98104, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98108, United States
TG Therapeutics Investigational Trial Site
Seattle Washington, 98109, United States
TG Therapeutics Investigational Trial Site
Spokane Washington, 99216, United States
TG Therapeutics Investigational Trial Site
Vancouver Washington, 97277, United States
TG Therapeutics Investigational Trial Site
Madison Wisconsin, 53792, United States
TG Therapeutics Investigational Trial Site
Wauwatosa Wisconsin, 53226, United States
TG Therapeutics Investigational Trial Site
Gosford New South Wales, 02250, Australia
TG Therapeutics Investigational Trial Site
Wahroonga New South Wales, 02076, Australia
TG Therapeutics Investigational Trial Site
Benowa Queensland, 04217, Australia
TG Therapeutics Investigational Trial Site
South Brisbane Queensland, 04101, Australia
TG Therapeutics Investigational Trial Site
Adelaide South Australia, 05000, Australia
TG Therapeutics Investigational Trial Site
Heidelberg Victoria, 03084, Australia
TG Therapeutics Investigational Trial Site
Nedlands Western Australia, 06009, Australia
TG Therapeutics Investigational Trial Site
Netherlands Western Australia, 06009, Australia
TG Therapeutics Investigational Trial Site
Gosford , 2076, Australia
TG Therapeutics Investigational Trial Site
Ashkelon , 78306, Israel
TG Therapeutics Investigational Trial Site
Be'er Sheva , 84101, Israel
TG Therapeutics Investigational Trial Site
Haifa , 91031, Israel
TG Therapeutics Investigational Trial Site
Jerusalem , 91120, Israel
TG Therapeutics Investigational Trial Site
Nahariya , 22100, Israel
TG Therapeutics Investigational Trial Site
Petah Tikva , 49100, Israel
TG Therapeutics Investigational Trial Site
Tel Aviv , 64239, Israel
TG Therapeutics Investigational Trial Site
Tel Aviv , 69710, Israel
TG Therapeutics Investigational Trial Site
Bologna , 40138, Italy
TG Therapeutics Investigational Trial Site
Ferrara , 44020, Italy
TG Therapeutics Investigational Trial Site
Milan , 20132, Italy
TG Therapeutics Investigational Trial Site
Milan , 20141, Italy
TG Therapeutics Investigational Trial Site
Rome , 00161, Italy
TG Therapeutics Investigational Trial Site
Torino , 10126, Italy
TG Therapeutics Investigational Trial Site
Busan , 47392, Korea, Republic of
TG Therapeutics Investigational Trial Site
Busan , 49241, Korea, Republic of
TG Therapeutics Investigational Trial Site
Gyeonggi-do , 13620, Korea, Republic of
TG Therapeutics Investigational Trial Site
Incheon , 21565, Korea, Republic of
TG Therapeutics Investigational Trial Site
Seoul , 03080, Korea, Republic of
TG Therapeutics Investigational Trial Site
Seoul , 06351, Korea, Republic of
TG Therapeutics Investigational Trial Site
Seoul , 06591, Korea, Republic of
TG Therapeutics Investigational Trial Site
Chorzów , 41-50, Poland
TG Therapeutics Investigational Trial Site
Gdynia , 81-51, Poland
TG Therapeutics Investigational Trial Site
Kraków , 30-51, Poland
TG Therapeutics Investigational Trial Site
Lublin , 20-09, Poland
TG Therapeutics Investigational Trial Site
Słupsk , 76-20, Poland
TG Therapeutics Investigational Trial Site
Warszawa , 02-10, Poland
TG Therapeutics Investigational Trial Site
Warszawa , 02-78, Poland
TG Therapeutics Investigational Trial Site
Wrocław , 50-36, Poland
TG Therapeutics Investigational Trial Site
Łódź , 93-51, Poland
TG Therapeutics Investigational Trial Site
Bratislava , 81250, Slovakia
TG Therapeutics Investigational Trial Site
Bratislava , 83310, Slovakia
TG Therapeutics Investigational Trial Site
Košice , 04191, Slovakia
TG Therapeutics Investigational Trial Site
Poprad , 05801, Slovakia
TG Therapeutics Investigational Trial Site
Barcelona , 08035, Spain
TG Therapeutics Investigational Trial Site
Barcelona , 08041, Spain
TG Therapeutics Investigational Trial Site
Madrid , 28041, Spain
TG Therapeutics Investigational Trial Site
Madrid , 28222, Spain
TG Therapeutics Investigational Trial Site
Salisbury , 37007, Spain
TG Therapeutics Investigational Trial Site
Valencia , 46010, Spain
TG Therapeutics Investigational Trial Site
Cambridge , CB2-0, United Kingdom
TG Therapeutics Investigational Trial Site
Denmark Hill , SE5-9, United Kingdom
TG Therapeutics Investigational Trial Site
Leeds , LS97T, United Kingdom
TG Therapeutics Investigational Trial Site
Liverpool , L7-8X, United Kingdom
TG Therapeutics Investigational Trial Site
London , EC1A-, United Kingdom
TG Therapeutics Investigational Trial Site
London , SW170, United Kingdom
TG Therapeutics Investigational Trial Site
Oxford , OX37L, United Kingdom
TG Therapeutics Investigational Trial Site
Plymouth , PL68D, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

710

Study ID:

NCT02793583

Recruitment Status:

Terminated

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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