Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
NCT ID: NCT03828448
Last Updated: 2023-07-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
34 participants
INTERVENTIONAL
2019-07-10
2022-05-31
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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Ublituximab + Umbralisib
Participants were administered ublituximab, 900 milligrams (mg), intravenous (IV) infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days.
Ublituximab
\- anti-CD 20 monoclonal antibody administered via IV infusion
Umbralisib
\- PI3K Delta Inhibitor oral daily dose
Interventions
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Ublituximab
\- anti-CD 20 monoclonal antibody administered via IV infusion
Umbralisib
\- PI3K Delta Inhibitor oral daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease that requires treatment
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion Criteria
* Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1
* Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
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
Fort Myers, Florida, United States
TG Therapeutics Investigational Trial Site
St. Petersburg, Florida, United States
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States
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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UTX-TGR-203
Identifier Type: -
Identifier Source: org_study_id
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