Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy
NCT ID: NCT02742090
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
51 participants
INTERVENTIONAL
2016-04-21
2021-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Umbralisib
Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months.
Umbralisib
Umbralisib was administered as a tablet(s), orally once daily.
Interventions
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Umbralisib
Umbralisib was administered as a tablet(s), orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
* Presence of measurable disease
Exclusion Criteria
* Prior treatment with TGR-1202
* Richter's transformation or CLL transformation to aggressive lymphoma
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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Anthony Mato, MD
Role: STUDY_CHAIR
University of Pennsylvania Center for CLL
Locations
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TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, United States
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, United States
TG Therapeutics Investigational Trial Site
St. Petersburg, Florida, United States
TG Therapeutics Investigational Trial Site
Kansas City, Missouri, United States
TG Therapeutics Investigational Trial Site
Lebanon, New Hampshire, United States
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States
TG Therapeutics Investigational Trial Site
New Hyde Park, New York, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial Site
Rochester, New York, United States
TG Therapeutics Investigational Trial Site
Durham, North Carolina, 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
Nashville, Tennessee, United States
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States
Countries
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References
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Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TGR-1202-201-CLL
Identifier Type: -
Identifier Source: org_study_id
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