drugset / Trial / NCT02983617
Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the preliminary efficacy of the combination of tirabrutinib (formerly GS-4059) and entospletinib with obinutuzumab in adults with relapsed or refractory chronic lymphocytic leukemia (CLL).
Timeline
- Start
- 2017-04-06
- Primary completion
- 2019-02-20
- Completion
- 2020-10-01
Publications
- Results Kutsch, N et al. A Prospective, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib (ONO/GS-4059) and Entospletinib with and without Obinutuzumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL), Blood (2019) 134 (Supplement_1): 4297.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entospletinib | Small molecule | 400 mg | Oral |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Tirabrutinib | Small molecule | 80 mg | Oral |