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| Title | A Prospective, Randomized, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of GS-4059 and Entospletinib with and without Obinutuzumab in Subjects with Chronic Lymphocytic Leukemia |
|---|---|
| Protocol IDs | EudraCT: 2016-002768-15 NCT02983617 |
| Status | in follow up |
| General Inquiries | cll-umbrella@uk-koeln.de |
| Contact | Medical Management: Dr. Nadine Kutsch Dr. Nadine Kutsch Aline Zey |
| Contact for scientific queries | Prof. Dr. Barbara Eichhorst Prof. Dr. Barbara Eichhorst |
| Design | Prospective, open-label, randomized, multicenter phase 2 study |
| Primary Endpoint | Rate of complete remission (CR) according to the IWCLL guidelines at Week 25 |
| Secondary Endpoints | - Rate of complete response (CR) with bone marrow minimal
residual disease (MRD) negativity (CR/BM MRD-) at Week 25 - Rate of CR with MRD negativity (<10-4) in peripheral blood (CR/PB MRD-) at Week 25 - Overall response rate (ORR) at Week 25 - Progression-free survival (PFS) - Type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) |
| Study Population | - Relapsed or refractory CLL - Requiring treatment per modified IWCLL 2008 criteria AND radiographically measureable disease (CT, MRI) - no prior therapy with any inhibitor of BTK, SYK, PI3K, BCL-2 or obinutuzumab - Age ≥ 18 years |
| Treatment | Arm A (GS-4059 + Entospletinib) up to 104 weeks GS-4059 p.o.: 80 mg daily Entospletinib p.o.: 400 mg daily |
| Arm B (GS-4059 + Entospletinib + Obinutuzumab) up to 104 weeks GS-4059 p.o.: 80 mg daily Idelalisib p.o.: 400 mg daily Entospletinib i.v. 6 cycles, q 28d (= 21 weeks) Cycle 1: (100 mg, d1 + 900 mg, d2) or 1000 mg, d1; 1000 mg, d8 + d15 Cycle 2 - 6: 1000 mg, d1 |
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| Patients recruited | 36 patients |
| Time schedule | Recruitment period:: 06 April 2017 - 04 September 2018 End of Study: Q1/2023 |
| Protocol Version | Protocol (25 August 2016) Amendment 1 (16 November 2016) |
| Sponsor | Gilead Sciences, Inc. |
| Principal Investigator | Prof. Dr. Barbara Eichhorst, Dept. Internal Medicine I, University Hospital of Cologne |
| Coordinating Physician | Dr. Nadine Kutsch, Dept. Internal Medicine I, University Hospital of Cologne |
| Documents (password protected) |
https://sso.praintl.com/prasso/login/portal Access only with personal username and password, which have been sent to the study centers. |