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Observational study of acalabrutinib for chronic lymphocytic leukaemia in the UK

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).

Observational AstraZeneca · NCT05557695

This study looks at how well acalabrutinib works for people with chronic lymphocytic leukaemia in the UK by collecting real-life treatment data from their medical records.

Quick facts

Study typeObservational
Enrollment350 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsacalabrutinib
Locations29 sites (Aylesbury and 28 other locations)
Trial IDNCT05557695 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world clinical data on patients with chronic lymphocytic leukaemia (CLL) who have received acalabrutinib as part of the Early Access Programme in the UK. Physicians treating these patients will recruit participants, and clinical data will be extracted from their medical records in compliance with local regulations. The study will estimate progression-free survival, overall survival, response rates, and healthcare resource utilization among treatment-naïve patients who started acalabrutinib between April 2020 and April 2021.

Who should consider this trial

Good fit: Ideal candidates include treatment-naïve patients with chronic lymphocytic leukaemia who started acalabrutinib as part of the UK Early Access Programme.

Not a fit: Patients who have previously received treatment for CLL or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of acalabrutinib in real-world settings for CLL patients.

How similar studies have performed: Other studies have shown success with similar observational approaches, providing real-world evidence for treatment outcomes in CLL.

Eligibility criteria

Show full inclusion / exclusion criteria 
The study population will include treatment-naïve patients with chronic lymphocytic lymphoma (CLL)\* who meet the following inclusion criteria:

* 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.

Exclusion Criteria:

\- None listed in study protocol

Where this trial is running

Aylesbury and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Lymphocytic Leukemia, CLLCLL, real-world evidence, acalabrutinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.