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Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom

NCT05557695

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Chronic Lymphocytic Leukemia, CLL

Interventions: Acalabrutinib

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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
Locations (29)
  • Aylesbury, United Kingdom
  • Bath, United Kingdom
  • Birmingham, United Kingdom
  • Bournemouth, United Kingdom
  • Cardiff, United Kingdom
  • Cornwall, United Kingdom
  • Dartford, United Kingdom
  • Derby, United Kingdom
  • Doncaster, United Kingdom
  • Dorset, United Kingdom
  • Eastbourne, United Kingdom
  • Hull, United Kingdom
  • Leicester, United Kingdom
  • Lincoln, United Kingdom
  • Liverpool, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Mid Yorkshire, United Kingdom
  • Middlesbrough, United Kingdom
  • Newcastle, United Kingdom
  • North Shields, United Kingdom
  • Norwich, United Kingdom
  • Nottingham, United Kingdom
  • Oxford, United Kingdom
  • Plymouth, United Kingdom
  • Southampton, United Kingdom
  • Stockton-on-Tees, United Kingdom
  • Stoke-on-Trent, United Kingdom
  • Wigan, United Kingdom