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
NCT ID: NCT02793583
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
710 participants
INTERVENTIONAL
2016-05-25
2022-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Umbralisib + Ublituximab
Umbralisib oral daily dose in combination with Ublituximab intravenous administration
Ublituximab
Umbralisib
Umbralisib
Umbralisib oral daily dose
Umbralisib
Umbralisib + Ublituximab + Bendamustine
Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration
Ublituximab
Umbralisib
Bendamustine
Interventions
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Ublituximab
Umbralisib
Bendamustine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Owen A O'Connor, MD, PhD
Role: STUDY_CHAIR
Columbia University
Locations
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TG Therapeutics Investigational Trial Site
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Chandler, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Fort Collins, Colorado, United States
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Bridgeport, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Albany, Georgia, United States
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Macon, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Evanston, Illinois, United States
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Harvey, Illinois, United States
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Maywood, Illinois, United States
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Niles, Illinois, United States
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Peoria, Illinois, United States
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Swansea, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Westwood, Kansas, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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Brewer, Maine, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Towson, Maryland, United States
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Ann Arbor, Michigan, United States
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Duluth, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Mount Holly, New Jersey, United States
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Farmington, New Mexico, United States
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Buffalo, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Kinston, North Carolina, United States
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Raleigh, North Carolina, United States
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Washington, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Springfield, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Watertown, South Dakota, United States
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Chattanooga, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Sam Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Ogden, Utah, United States
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Blacksburg, Virginia, United States
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Newport News, Virginia, United States
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Olympia, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Madison, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Gosford, New South Wales, Australia
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Wahroonga, New South Wales, Australia
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Benowa, Queensland, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Heidelberg, Victoria, Australia
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Nedlands, Western Australia, Australia
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Netherlands, Western Australia, Australia
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Gosford, , Australia
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Ashkelon, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Ferrara, , Italy
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Milan, , Italy
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Milan, , Italy
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Rome, , Italy
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Torino, , Italy
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Chorzów, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Słupsk, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Poprad, , Slovakia
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Busan, , South Korea
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Busan, , South Korea
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Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Salisbury, , Spain
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Valencia, , Spain
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Cambridge, , United Kingdom
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Denmark Hill, , United Kingdom
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Leeds, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
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Plymouth, , United Kingdom
Countries
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References
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Fowler NH, Samaniego F, Jurczak W, Ghosh N, Derenzini E, Reeves JA, Knopinska-Posluszny W, Cheah CY, Phillips T, Lech-Maranda E, Cheson BD, Caimi PF, Grosicki S, Leslie LA, Chavez JC, Fonseca G, Babu S, Hodson DJ, Shao SH, Burke JM, Sharman JP, Law JY, Pagel JM, Miskin HP, Sportelli P, O'Connor OA, Weiss MS, Zinzani PL. Umbralisib, a Dual PI3Kdelta/CK1epsilon Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2021 May 20;39(15):1609-1618. doi: 10.1200/JCO.20.03433. Epub 2021 Mar 8.
Other Identifiers
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UTX-TGR-205
Identifier Type: -
Identifier Source: org_study_id
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