Title | A prospective, multicenter phase II trial of acalabrutinib in very old (≥80y) or frail CLL-Patients |
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Protocol IDs | EudraCT: 2020-002142-17 NCT04883749 |
Participating Countries | Germany, Austria |
Status | Recruiting |
Contact | Medical Management: Prof. Dr. Barbara Eichhorst Prof. Dr. Barbara Eichhorst Christina Paulitschek Ronald D’Brot Tanja Annolleck |
Contact for scientific queries | Prof. Dr. Barbara Eichhorst Prof. Dr. Barbara Eichhorst Dr. Florian Simon |
Design | Prospective, multicentre, single-arm, open-label phase II trial |
Primary Endpoint | Overall response rate (ORR) at initial response assessment (cycle 7, day 1 = approx. 6 months after initiation of therapy). |
Secondary Endpoints | - ORR at final restaging (cycle 25, day 1 = approx. 24 months after initiation of therapy). - Overall survival (OS) - Progression free survival (PFS) - Event-free survival (EFS) - Duration of response - Time to next CLL treatment (TTNT) - Feasibility parameters: Modification of treatment, treatment discontinuation, treatment exposure, time on treatment - Safety parameters: Type, frequency, and severity of adverse events (AEs) and adverse events of special interest (AESI) and their relationship to study treatment |
Exploratory endpoints - Health-related quality of life (by EORTC QLQC30 and QLQCLL17 questionnaires) - Exploratory evaluations of potential associations between various baseline markers and clinical outcome parameters - Frailty-assessment via FRAIL scale score at initial response assessment and final restaging |
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Study Population | - B-CLL according to the iwCLL guidelines 2018, requiring treatment - Age ≥ 80 years AND/OR considered too frail for intensive/standard treatment (frailty score of > 2 on the FRAIL scale) - Maximum of 1 previous treatment for CLL - No prior exposure to acalabrutinib - Eastern Cooperative Oncology Group (ECOG) performance status >3 |
Treatment | Acalabrutinib p.o. Cycle (q28): 100 mg, twice daily Acalabrutinib will be administered up to 24 cycles (= approx. 24 months total) until progression of disease (PD) or intolerable toxicity |
Targeted Accrual | Approx. 50 eligible patients |
Time schedule | Start of recruitment: Q1/2021 Expected end of recruitment: Q3/2022 End of trial: Q3/2024 |
Protocol Version | Protocol (Version 1.1 | 21 Jan 2021) |
Sponsor | University of Cologne |
Global Principal Investigator | Prof. Dr. med. Barbara Eichhorst, Department I of Internal Medicine, Cologne University Hospital |
Coordinating Physician | Dr. Florian Simon, Department I of Internal Medicine, Cologne University Hospital |
Documents (publicly available) |
Synopsis (Version 1.1 | 21 Jan 2021) |
Documents (password protected) |
Protocol and other documents see Download Center |