Title | A prospective, multicenter, phase-II trial evaluating efficacy and safety of Bendamustine + GA101 (BG) in patients with relapsed CLL followed by maintenance therapy with GA101 for responding patients |
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Protocol IDs | EudraCT: 2013-001088-22 NCT02320383 |
Status | prematurely terminated due to poor accrual; trial in follow up |
Contact | Medical Management: Dr. Nadine Kutsch Dr. Nadine Kutsch Dr. Emily Holmes Irene Preißler-Stodden Tanja Annolleck |
Contact for scientific queries | Prof. Dr. Clemens Wendtner, Klinikum München Schwabing Prof. Dr. Clemens Wendtner Dr. Nadine Kutsch |
Design | Prospective, multicenter, open-label phase-II trial |
Primary Objective | To evaluate the efficacy of Bendamustine plus GA101 (BG) in patients with relapsed CLL |
Primary Endpoint | Overall response rate (ORR) |
Secondary Endpoints | - MRD levels during treatment and maintenance - Progression free survival (PFS)) - Event-free survival (EFS) - Overall survival (OS) - Overall response to maintenance treatment - Duration of response in patients with CR/ CRi, clinical CR / clinical CRi or nPR/ PR - Time to next anti-leukemia treatment - Complete response rate - Komplette Ansprechrate (Complete response rate) - Safety parameters during induction and maintenance phase (AEs, AESI) - Evaluation of relationship between various baseline markers and clinical outcome parameters - Evaluation of patients randomized into the prematurely closed FCG study arm with regard to efficacy and safety parameters |
Study Population | - B-CLL in need of treatment according to
the iwCLL guidelinese IWCLL guidelines - Relapsed disease - 1 - 3 prior regimens for CLL - no del(17p) / TP53 mutation - not refractory to FCR/BR - Medically fit patients without relevant comorbidity: CIRS score ≤ 6 (single score < 4 for one organ category) - ECOG performance status ≤ 2 - Age ≥ 18 years |
Treatment | Induction BG GA101 iv Cycle 1: d1 - 100 mg, (d1 or) d2 - 900 mg, d8+15 - 1000 mg Cycle 2 - 6: d1 - 1000 mg Bendamustin i.v. Cycle 1: d3+4 (or d2+3) - 70 mg/m² Cycle 2 - 6: d2+3 - 70 mg/m A maximum of 6 cycles of BG will be administered; each cycle with a duration of 28 days |
Maintenance GA010 After a maximum of 6 cycles of BG for patients in response (CR/ CRi, clinical CR/ CRi or nPR/ PR) GA101 iv 1000 mg (flat dose): every 84 days starting on final restaging continued until progression or to a maximum of 2 years |
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Enrollment | 27 patients |
Time schedule | Recruitment period: 11/2014 - 12/2017 |
Protocol Version | 06 August 2014 Protocol (Version 3.11) 28 March 2015 Amendment 1 (Version 4.0) 26 November 2015 Amendment 2 (Version 5.0) 22 August 2016 Amendment 3 (Version 6.1) |
Sponsor | Städtisches Klinikum München GmbH |
Principal Investigator | Prof. Dr. med. Clemens-M. Wendtner, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie und Tropenmedizin, Klinikum Schwabing, München |
Documents (publicly available) |
Synopsis |
Documents (password protected) |
Protocol and other documents see Download Center |