Real world outcomes of safety/efficacy of acalabrutinib for chronic lymphocytic leukaemia—A multicentre experience

Published Date: 17th April 2026

Publication Authors: Mwandumba. D

Acalabrutinib is a second generation Bruton's Tyrosine Kinase inhibitor (BTKi) approved for the treatment of CLL/SLL in both the treatment-naïve and relapsed/refractory setting. This is based on evidence of efficacy from several clinical trials including ELEVATE-TN and ASCEND. Since the widespread use of acalabrutinib there have been a number of real-world data studies, comparing clinical trial outcomes with those in routine clinical practice. Here, we present real-world data on the use of acalabrutinib in CLL/SLL from the North-West of England, reviewing clinical outcomes including key safety and efficacy measures.

This retrospective analysis was conducted using data from several hospitals in the North-West region, focussing on all patients who commenced acalabrutinib as a treatment for CLL/SLL since it became available as part of routine NHS care, both in the 1L and 2L+ settings. We gathered data from medical records from 2019 to 2025 looking at baseline demographic characteristics, whether 1L or 2L+ treatment, p53 and IGHV mutational status, progression free survival (PFS), time to next treatment (TTNT) and overall survival (OS).

A total of 121 patients were identified, of which 79 were male and 42 were female with a male:female ratio of 1.88:1. The average age at the start of treatment with acalabrutinib was 73. 89/121 (73.6%) of patients commenced treatment in the 1L setting, whilst 32/121 (26.4%) of patient commenced treatment in the 2L+ setting. Either TP53 mutation or 17p deletion were detected in 18.2% of patients, with 7.4% having both TP53 mutation and 17p deletion. IGHV unmutated patients accounted for 39.7% of patients overall.

Over the whole 6-year period, 9/121 patients (9.1%) had disease progression whilst on treatment. Overall, 12.3% of patients required a subsequent treatment for CLL, of which 53% were due to adverse events (AEs) and 47% due to disease progression. 12.3% of patients died, with 40% of these related to CLL and 20% (3/121) due to potential AE of treatment.

Grade 3 or more AE were recorded in 25.6% of patients. The most common significant adverse events were infection (29.8%), bruising (25.6%), cytopenias (19.8%) (by cell line—neutropenia (9.1%), thrombocytopenia (7.4%), anaemia (3.3%)), hypertension (9.1%), bleeding (8.2%) with major bleeding (4.1%), cardiac disorders (7.4%) which included atrial fibrillation (4.1%).

This real-world analysis is broadly reflective of previous trial data and confirms the safety and efficacy of acalabrutinib in routine clinical practice.

Clarke, J.; Mwandumba, D. et al. (2026). Real world outcomes of safety/efficacy of acalabrutinib for chronic lymphocytic leukaemia—A multicentre experience. British Journal of Haematology. 208(S1), pp.S53-S54. [Online]. Available at: https://onlinelibrary.wiley.com/doi/10.1111/bjh.70471 [Accessed 10 September 2026].