drugset / Trial / NCT04016805
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
Timeline
- Start
- 2019-08-05
- Primary completion
- 2022-05-22
- Completion
- 2022-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ublituximab | Monoclonal antibody | 900 mg | Intravenous |
| Subject | Umbralisib | Small molecule | 800 mg | Oral |
| Background | Acalabrutinib | Small molecule | — | Oral |
| Background | Ibrutinib | Small molecule | — | Oral |
| Background | Venetoclax | Small molecule | — | Oral |