CLL-Frail Trial

Title A prospective, multicenter phase II trial of acalabrutinib in
very old (≥80y) or frail CLL-Patients
Protocol IDs EudraCT: 2020-002142-17
Participating Countries Germany, Austria
Status Recruiting
Contact Medical Management: Prof. Dr. Barbara Eichhorst

Prof. Dr. Barbara Eichhorst
+49 221 478-88155 (Office)

Project Management: Christina Paulitschek

Christina Paulitschek
+49 221 478-89775

Data Management: Ronald D’Brot

Ronald D’Brot
+49 221 478-89690

Safety Management: Tanja Annolleck

Tanja Annolleck
+49 221 478-96579

Contact for scientific queries Prof. Dr. Barbara Eichhorst

Prof. Dr. Barbara Eichhorst
+49 221 478-88155 (Office)

Dr. Florian Simon

Dr. Florian Simon
+49 221 478-88220 (Office)

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
- 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
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
(publicly available)
Synopsis (Version 1.1 | 21 Jan 2021)
(password protected)
Protocol and other documents see Download Center