Trials / Completed
CompletedNCT02301156
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 (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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ublituximab | Administered as an IV infusion |
| DRUG | Ibrutinib | Administered orally |
Timeline
- Start date
- 2015-01-27
- Primary completion
- 2020-04-01
- Completion
- 2020-04-01
- First posted
- 2014-11-25
- Last updated
- 2022-05-20
- Results posted
- 2022-05-20
Locations
88 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02301156. Inclusion in this directory is not an endorsement.