Title | A Prospective, Randomized, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of GS-4059 and Idelalisib with and without Obinutuzumab in Subjects with Chronic Lymphocytic Leukemia |
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Protocol IDs | EudraCT: 2015-003909-42 NCT02968563 |
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 + Idelalisib) up to 104 weeks GS-4059 p.o.: 80 mg daily Idelalisib p.o.: 100 mg daily |
Arm B (GS-4059 + Idelalisib + Obinutuzumab) up to 104 weeks GS-4059 p.o.: 80 mg daily Idelalisib p.o.: 100 mg daily Obinutuzumab 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 | 35 patients |
Time schedule | Recruitment period: 10 Jan 2017 - 03 Jan 2019 End of Study: Q4/2022 |
Protocol Version | Protocol (01 June 2016) Amendment 1 (16 Aug. 2016) Amendment 2 (16 Sept. 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. |