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
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).
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
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There are 167 Locations for this study
Birmingham Alabama, 35243, United States
Huntsville Alabama, 35805, United States
Chandler Arizona, 85224, United States
Tucson Arizona, 85711, United States
Tucson Arizona, 85724, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
San Diego California, 90710, United States
San Diego California, 92108, United States
Whittier California, 90603, United States
Aurora Colorado, 80012, United States
Denver Colorado, 80218, United States
Fort Collins Colorado, 80528, United States
Bridgeport Connecticut, 06606, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20007, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33916, United States
Gainesville Florida, 32608, United States
Jacksonville Florida, 32204, United States
Jacksonville Florida, 32224, United States
Jacksonville Florida, 32256, United States
Miami Florida, 33176, United States
Saint Petersburg Florida, 33705, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33612, United States
West Palm Beach Florida, 33407, United States
Albany Georgia, 31701, United States
Macon Georgia, 31201, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
Maywood Illinois, 60153, United States
Niles Illinois, 60714, United States
Peoria Illinois, 61615, United States
Swansea Illinois, 62226, United States
Fort Wayne Indiana, 46845, United States
Indianapolis Indiana, 46237, United States
Westwood Kansas, 66210, United States
Louisville Kentucky, 40207, United States
Covington Louisiana, 70433, United States
Brewer Maine, 04412, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20817, United States
Columbia Maryland, 21044, United States
Towson Maryland, 21204, United States
Ann Arbor Michigan, 48109, United States
Duluth Minnesota, 55805, United States
Saint Louis Park Minnesota, 55416, United States
Columbia Missouri, 65212, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59102, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68130, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07962, United States
Mount Holly New Jersey, 08060, United States
Farmington New Mexico, 87401, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
New York New York, 10019, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28201, United States
Durham North Carolina, 27705, United States
Hickory North Carolina, 28602, United States
Kinston North Carolina, 28501, United States
Raleigh North Carolina, 27607, United States
Washington North Carolina, 27889, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43219, United States
Toledo Ohio, 43623, 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, 19106, United States
Providence Rhode Island, 02906, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Watertown South Dakota, 57201, United States
Chattanooga Tennessee, 37404, United States
Kingsport Tennessee, 37660, United States
Knoxville Tennessee, 37916, United States
Memphis Tennessee, 38120, United States
Austin Texas, 78705, United States
Dallas Texas, 75390, United States
Fort Sam Houston Texas, 78234, United States
Houston Texas, 77030, United States
San Antonio Texas, 78130, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78229, United States
Tyler Texas, 75702, United States
Ogden Utah, 84403, United States
Blacksburg Virginia, 24060, United States
Newport News Virginia, 23601, United States
Olympia Washington, 98502, United States
Seattle Washington, 98104, United States
Seattle Washington, 98108, United States
Seattle Washington, 98109, United States
Spokane Washington, 99216, United States
Vancouver Washington, 97277, United States
Madison Wisconsin, 53792, United States
Wauwatosa Wisconsin, 53226, United States
Gosford New South Wales, 02250, Australia
Wahroonga New South Wales, 02076, Australia
Benowa Queensland, 04217, Australia
South Brisbane Queensland, 04101, Australia
Adelaide South Australia, 05000, Australia
Heidelberg Victoria, 03084, Australia
Nedlands Western Australia, 06009, Australia
Netherlands Western Australia, 06009, Australia
Gosford , 2076, Australia
Ashkelon , 78306, Israel
Be'er Sheva , 84101, Israel
Haifa , 91031, Israel
Jerusalem , 91120, Israel
Nahariya , 22100, Israel
Petah Tikva , 49100, Israel
Tel Aviv , 64239, Israel
Tel Aviv , 69710, Israel
Bologna , 40138, Italy
Ferrara , 44020, Italy
Milan , 20132, Italy
Milan , 20141, Italy
Rome , 00161, Italy
Torino , 10126, Italy
Busan , 47392, Korea, Republic of
Busan , 49241, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Chorzów , 41-50, Poland
Gdynia , 81-51, Poland
Kraków , 30-51, Poland
Lublin , 20-09, Poland
SÅ‚upsk , 76-20, Poland
Warszawa , 02-10, Poland
Warszawa , 02-78, Poland
Wrocław , 50-36, Poland
Åódź , 93-51, Poland
Bratislava , 81250, Slovakia
Bratislava , 83310, Slovakia
Košice , 04191, Slovakia
Poprad , 05801, Slovakia
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Madrid , 28041, Spain
Madrid , 28222, Spain
Salisbury , 37007, Spain
Valencia , 46010, Spain
Cambridge , CB2-0, United Kingdom
Denmark Hill , SE5-9, United Kingdom
Leeds , LS97T, United Kingdom
Liverpool , L7-8X, United Kingdom
London , EC1A-, United Kingdom
London , SW170, United Kingdom
Oxford , OX37L, United Kingdom
Plymouth , PL68D, United Kingdom
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