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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COMPLETED
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2014-01-06
2015-12-31
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 + ibrutinib
Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose
Ublituximab
Ublituximab (IV infusion)
Ibrutinib
Ibrutinib oral daily dose
Interventions
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Ublituximab
Ublituximab (IV infusion)
Ibrutinib
Ibrutinib oral daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion Criteria
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
* Richter's transformation, prolymphocytic leukemia or primary central nervous system 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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Jeff Sharman, MD
Role: STUDY_CHAIR
Willamette Valley Cancer Institute
Locations
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TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Tucson, Arizona, United States
TG Therapeutics Investigational Trial Site
Santa Barbara, California, United States
TG Therapeutics Investigational Trial Site
Boulder, Colorado, United States
TG Therapeutics Investigational Trial Site
Niles, Illinois, United States
TG Therapeutics Investigational Trial Site
Urbana, Illinois, United States
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, United States
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, 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
Greenville, South Carolina, United States
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, United States
TG Therapeutics Investigational Trial Site
Austin, Texas, United States
TG Therapeutics Investigational Trial Site
Dallas, Texas, United States
TG Therapeutics Investigational Trial Site
Tyler, Texas, United States
TG Therapeutics Investigational Trial Site
Blacksburg, Virginia, United States
TG Therapeutics Investigational Trial Site
Fairfax, Virginia, United States
TG Therapeutics Investigational Trial Site
Vancouver, Washington, United States
Countries
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Other Identifiers
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UTX-IB-104
Identifier Type: -
Identifier Source: org_study_id
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