Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
EPIC
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).
1 other identifier
observational
350
1 country
29
Brief Summary
This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with chronic lymphocytic leukaemia receiving acalabrutinib in the United Kingdom (the EPIC study). Physicians treating chronic lymphocytic leukaemia patients with acalabrutinib, where the patients started treatment as part of the acalabrutinib Early Access Programme (EAP), will be invited to recruit patients. Clinical data will be extracted from the patients' clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients who were started on acalabrutinib as part of the UK acalabrutinib EAP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
September 28, 2022
CompletedStudy Start
First participant enrolled
October 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 23, 2026
April 1, 2026
4.5 years
August 24, 2022
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
12 months
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
24 months
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
36 months
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
48 months
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
60 months
Secondary Outcomes (16)
Real-world overall survival (rwOS)
12 months
Real-world overall survival (rwOS)
24 months
Real-world overall survival (rwOS)
36 months
Real-world overall survival (rwOS)
48 months
Real-world overall survival (rwOS)
60 months
- +11 more secondary outcomes
Study Arms (1)
Group 1
Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line
Interventions
Eligibility Criteria
Treatment-naïve adults (≥18 years old) with chronic lymphocytic lymphoma (CLL) who were initiated on acalabrutinib as part of the UK acalabrutiinib early access programme and received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021.
You may qualify if:
- Treatment-naïve CLL patients who were initiated on acalabrutinib as part of the UK Early Access Programme
- Received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021
- Patients aged ≥18 years old
- Note: patients later found to have small lymphocytic lymphoma (SLL) may also be included in the EAP.
You may not qualify if:
- \- None listed in study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- UKCLL Forumcollaborator
Study Sites (29)
Research Site
Aylesbury, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Birmingham, United Kingdom
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Bournemouth, United Kingdom
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Cardiff, United Kingdom
Research Site
Cornwall, United Kingdom
Research Site
Dartford, United Kingdom
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Derby, United Kingdom
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Doncaster, United Kingdom
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Dorset, United Kingdom
Research Site
Eastbourne, United Kingdom
Research Site
Hull, United Kingdom
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Leicester, United Kingdom
Research Site
Lincoln, United Kingdom
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Liverpool, United Kingdom
Research Site
London, SE1 9RT, United Kingdom
Research Site
London, W12 OHS, United Kingdom
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Mid Yorkshire, United Kingdom
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Middlesbrough, United Kingdom
Research Site
Newcastle, United Kingdom
Research Site
North Shields, United Kingdom
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Norwich, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Oxford, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
Research Site
Stockton-on-Tees, United Kingdom
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Stoke-on-Trent, United Kingdom
Research Site
Wigan, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toby A Eyre
Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
September 28, 2022
Study Start
October 17, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04