Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Completed · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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 (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.
Key facts
- Study ID
- NCT02301156
- Run by
- TG Therapeutics, Inc.
- People needed
- 126
- Starts
- 2015-01-27
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2022-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- TG Therapeutics Investigational Trial Site — Howell Township, New Jersey, United States
- TG Therapeutics Investigational Trial Site — Morristown, New Jersey, United States
- TG Therapeutics Investigational Trial Site — Pompton Plains, New Jersey, United States
- TG Therapeutics Investigational Trial Site — Somerville, New Jersey, United States
- TG Therapeutics Investigational Trial Site — New York, New York, United States
- TG Therapeutics Investigational Trial Site — Syracuse, New York, United States
- TG Therapeutics Investigational Trial Site — Charlotte, North Carolina, United States
- TG Therapeutics Investigational Trial Site — Durham, North Carolina, United States
- TG Therapeutics Investigational Trial Site — Raleigh, North Carolina, United States
- TG Therapeutics Investigational Trial Site — Canton, Ohio, United States
- TG Therapeutics Investigational Trial Site — Cincinnati, Ohio, United States
- TG Therapeutics Investigational Trial Site — Cleveland, Ohio, United States
- TG Therapeutics Investigational Trial Site — Portland, Oregon, 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 — Camp Hill, Pennsylvania, United States
- TG Therapeutics Investigational Trial Site — Philadelphia, Pennsylvania, United States
- TG Therapeutics Investigational Trial Site — Pawtucket, Rhode Island, United States
- TG Therapeutics Investigational Trial Site — Greenville, South Carolina, United States
- TG Therapeutics Investigational Trial Site — Greenville, South Carolina, United States
- TG Therapeutics Investigational Trial Site — Sioux Falls, South Dakota, United States
- TG Therapeutics Investigational Trial Site — Watertown, South Dakota, United States
- TG Therapeutics Investigational Trial Site — Memphis, Tennessee, United States
- TG Therapeutics Investigational Trial Site — Nashville, Tennessee, United States
- TG Therapeutics Investigational Trial Site — East Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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