Status:
COMPLETED
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (O...
Eligibility Criteria
Inclusion
- Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
- At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
- Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
- Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
Key Trial Info
Start Date :
January 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT02301156
Start Date
January 27 2015
End Date
April 1 2020
Last Update
May 20 2022
Active Locations (88)
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1
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States, 35805
2
TG Therapeutics Investigational Trial Site
Mobile, Alabama, United States, 36604
3
TG Therapeutics Investigational Trial Site
Chandler, Arizona, United States, 85224
4
TG Therapeutics Investigational Trial Site
Tucson, Arizona, United States, 85710