A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
NCT ID: NCT02656303
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
116 participants
INTERVENTIONAL
2016-01-07
2022-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parent Study Arm B
Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Ublituximab
Ublituximab IV infusion
Umbralisib
Umbralisib tablets
Parent Study Arm C
Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Ublituximab
Ublituximab IV infusion
Umbralisib
Umbralisib tablets
Parent Study Arm D
Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.
Ublituximab
Ublituximab IV infusion
Umbralisib
Umbralisib tablets
Interventions
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Ublituximab
Ublituximab IV infusion
Umbralisib
Umbralisib tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria
* Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
18 Years
ALL
No
Sponsors
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TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Chandler, Arizona, United States
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, United States
TG Therapeutics Investigational Trial Site
Duarte, California, United States
TG Therapeutics Investigational Trial Site
Pleasanton, California, United States
TG Therapeutics Investigational Trial Site
San Diego, California, United States
TG Therapeutics Investigational Trial Site
Whittier, California, United States
TG Therapeutics Investigational Trial Site
Aurora, Colorado, United States
TG Therapeutics Investigational Trial Site
Denver, Colorado, United States
TG Therapeutics Investigational Trial Site
Bridgeport, Connecticut, United States
TG Therapeutics Investigational Trial Site
New Haven, Connecticut, United States
TG Therapeutics Investigational Trial Site
Stamford, Connecticut, United States
TG Therapeutics Investigational Trial Site
Newark, Delaware, United States
TG Therapeutics Investigational Trial Site
Boca Raton, Florida, United States
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, United States
TG Therapeutics Investigational Trial Site
Jacksonville, Florida, United States
TG Therapeutics Investigational Trial Site
Jacksonville, Florida, United States
TG Therapeutics Investigational Trial Site
St. Petersburg, Florida, United States
TG Therapeutics Investigational Trial Site
Tallahassee, Florida, United States
TG Therapeutics Investigational Trial Site
West Palm Beach, Florida, United States
TG Therapeutics Investigational Trial Site
Albany, Georgia, United States
TG Therapeutics Investigational Trial Site
Chicago, Illinois, United States
TG Therapeutics Investigational Trial Site
Peoria, Illinois, United States
TG Therapeutics Investigational Trial Site
Swansea, Illinois, United States
TG Therapeutics Investigational Trial Site
Urbana, Illinois, United States
TG Therapeutics Investigational Trial Site
Fort Wayne, Indiana, United States
TG Therapeutics Investigational Trial Site
Indianapolis, Indiana, United States
TG Therapeutics Investigational Trial Site
Westwood, Kansas, United States
TG Therapeutics Investigational Trial Site
Louisville, Kentucky, United States
TG Therapeutics Investigational Trial Site
Worcester, Massachusetts, United States
TG Therapeutics Investigational Trial Site
Ann Arbor, Michigan, United States
TG Therapeutics Investigational Trial Site
Detroit, Michigan, United States
TG Therapeutics Investigational Trial Site
Jackson, Michigan, United States
TG Therapeutics Investigational Trial Site
Saint Louis Park, Minnesota, United States
TG Therapeutics Investigational Trial Site
Kansas City, Missouri, United States
TG Therapeutics Investigational Trial Site
Lincoln, Nebraska, United States
TG Therapeutics Investigational Trial Site
Lebanon, New Hampshire, United States
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, United States
TG Therapeutics Investigational Trial Site
Glens Falls, New York, United States
TG Therapeutics Investigational Trial Site
Syracuse, New York, United States
TG Therapeutics Investigational Trial Site
Charlotte, North Carolina, United States
TG Therapeutics Investigational Trial Site
Durham, North Carolina, United States
TG Therapeutics Investigational Trial Site
Durham, North Carolina, United States
TG Therapeutics Investigational Trial Site
Hickory, North Carolina, United States
TG Therapeutics Investigational Trial Site
Kinston, North Carolina, United States
TG Therapeutics Investigational Trial Site
Washington, North Carolina, United States
TG Therapeutics Investigational Trial Site
Canton, Ohio, United States
TG Therapeutics Investigational Trial Site
Toledo, Ohio, United States
TG Therapeutics Investigational Trial Site
Portland, Oregon, United States
TG Therapeutics Investigational Trial Site
Portland, Oregon, United States
TG Therapeutics Investigational Trial Site
Springfield, Oregon, United States
TG Therapeutics Investigational Trial Site
Camp Hill, Pennsylvania, United States
TG Therapeutics Investigational Trial Site
Hershey, Pennsylvania, United States
TG Therapeutics Investigational Trial Site
Philadelphia, Pennsylvania, United States
TG Therapeutics Investigational Trial Site
Pittsburgh, Pennsylvania, United States
TG Therapeutics Investigational Trial Site
Pawtucket, Rhode Island, United States
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, United States
TG Therapeutics Investigational Trial Site
Sioux Falls, South Dakota, United States
TG Therapeutics Investigational Trial Site
Chattanooga, Tennessee, United States
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States
TG Therapeutics Investigational Trial Site
Fort Worth, Texas, United States
TG Therapeutics Investigational Trial Site
San Antonio, Texas, United States
TG Therapeutics Investigational Trial Site
Ogden, Utah, United States
TG Therapeutics Investigational Trial Site
Blacksburg, Virginia, United States
TG Therapeutics Investigational Trial Site
Charlottesville, Virginia, United States
TG Therapeutics Investigational Trial Site
Fort Belvoir, Virginia, United States
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States
TG Therapeutics Investigational Trial Site
Spokane, Washington, United States
TG Therapeutics Investigational Trial Site
Wauwatosa, Wisconsin, United States
TG Therapeutics Investigational Trial Site
Ferrara, , Italy
TG Therapeutics Investigational Trial Site
Milan, , Italy
TG Therapeutics Investigational Trial Site
Milan, , Italy
TG Therapeutics Investigational Trial Site
Torino, , Italy
TG Therapeutics Investigational Trial Site
Chorzów, , Poland
TG Therapeutics Investigational Trial Site
Gdynia, , Poland
TG Therapeutics Investigational Trial Site
Krakow, , Poland
TG Therapeutics Investigational Trial Site
Lodz, , Poland
TG Therapeutics Investigational Trial Site
Lublin, , Poland
TG Therapeutics Investigational Trial Site
Słupsk, , Poland
TG Therapeutics Investigational Trial Site
Warsaw, , Poland
TG Therapeutics Investigational Trial Site
Warsaw, , Poland
TG Therapeutics Investigational Trial Site
Warsaw, , Poland
TG Therapeutics Investigational Trial Site
Warsaw, , Poland
TG Therapeutics Investigational Trial Site
London, , United Kingdom
TG Therapeutics Investigational Trial Site
Norwich, , United Kingdom
TG Therapeutics Investigational Trial Site
Sunderland, , United Kingdom
TG Therapeutics Investigational Trial Site
Wolverhampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016-004339-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UTX-TGR-204
Identifier Type: -
Identifier Source: org_study_id
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