A non-interventional, observational cohort study of Chronic Lymphocytic Leukaemia patients treated with acalabrutinib in the first-line setting through the UK Early Access Programme: Early access Programme outcomes In aCalabrutinib (EPIC)

This study is a multi-centre, non-interventional cohort study involving the collection of retrospective data from the medical records of patients who were initiated on acalabrutinib as part of the UK Early Access Program (EAP). The study is expected to include approximately 350 patients who received acalabrutinib as first-line treatment for Chronic lymphocytic leukaemia (CLL), from approximately 40 National Health Service (NHS) centres participating in the EAP in the United Kingdom (UK). Patients included in the study are expected to be followed for up to 60 months (5 years) from the date of the first acalabrutinib dose. At all centres, data collection will be performed by members of the direct care team, and de-identified data will be collected for all patients (living or deceased) to preserve patient confidentiality. The data collected will provide real world information on the characteristics, treatment patterns and clinical outcomes of UK patients with CLL who are treated with acalabrutnib in the first-line setting. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.