Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
NCT ID: NCT02535286
Last Updated: 2022-10-20
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
27 participants
INTERVENTIONAL
2015-09-18
2021-11-04
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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TG-1501 + Ublituximab + Umbralisib
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
Umbralisib
A once daily oral agent
ublituximab
IV anti-CD20 monoclonal antibody
TG-1501
IV immunotherapy for cancer
Interventions
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Umbralisib
A once daily oral agent
ublituximab
IV anti-CD20 monoclonal antibody
TG-1501
IV immunotherapy for cancer
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
* Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
TG Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony R. Mato, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial Site
Durham, North Carolina, United States
TG Therapeutics Investigational Trial Site
Philadelphia, Pennsylvania, United States
TG Therapeutics Investigational Trial Site
Seattle, Washington, United States
Countries
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Other Identifiers
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TG-UPCC-108
Identifier Type: -
Identifier Source: org_study_id
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