EPIC - NIS in CLL patients treated with acalabrutinib through the EAP
Research type
Research Study
Full title
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)
IRAS ID
303307
Contact name
Toby Eyre
Contact email
Sponsor organisation
AstraZeneca UK Limited
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
5 years, 3 months, 30 days
Research summary
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.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0140
Date of REC Opinion
7 Jun 2022
REC opinion
Favourable Opinion