drugset / Trial / NCT03010358
Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma
Phase 1/2
Completed
24 enrolled
Alexey Danilov, MD
Gilead Sciences · collabOregon Health and Science University · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I/II trial studies the side effect and best dose of entospletinib when giving together with obinutuzumab and to see how well they work in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that has come back. Entospletinib may stop the growth of cancer cells by blocking some of the enzymes need for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Giving entospletinib and obinutuzumab together may work better in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma.
Timeline
- Start
- 2017-07-17
- Primary completion
- 2021-04-29
- Completion
- 2021-04-29
Publications
- Background Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating MJ, Montserrat E, Rai KR, Kipps TJ; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008 Jun 15;111(12):5446-56. doi: 10.1182/blood-2007-06-093906. Epub 2008 Jan 23.
- Background Consensus resolution: proposed criteria for evaluation of response to treatment in hairy cell leukemia. Leukemia. 1987 Apr;1(4):405. No abstract available.
- Lam V, Best S, Kittai A, Orand K, Spurgeon SE, Liu T, Danilov AV. Proapoptotic and immunomodulatory effects of SYK inhibitor entospletinib in combination with obinutuzumab in patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2022 Feb;88(2):836-841. doi: 10.1111/bcp.14962. Epub 2021 Jul 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entospletinib | Small molecule | — | Oral |
| Background | Obinutuzumab | Monoclonal antibody | — | Intravenous |