drugset / Trial / NCT02612311
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.
Timeline
- Start
- 2015-11-19
- Primary completion
- 2023-02-22
- Completion
- 2023-02-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Chlorambucil | Other / unclassified | 0.5 mg/kg | Oral |
| Comparator | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Ublituximab | Monoclonal antibody | 900 mg | Intravenous |
| Subject | Umbralisib | Small molecule | 800 mg | Oral |