RecruitingNCT05557695

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

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).


Sponsor

AstraZeneca

Enrollment

350 participants

Start Date

Oct 17, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Inclusion Criteria4

  • 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 Criteria1

  • \- None listed in study protocol

Interventions

DRUGAcalabrutinib

Acalabrutinib


Locations(29)

Research Site

Liverpool, United Kingdom

Research Site

Aylesbury, United Kingdom

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Bath, United Kingdom

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Birmingham, United Kingdom

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Bournemouth, United Kingdom

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Cardiff, United Kingdom

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Cornwall, United Kingdom

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Dartford, United Kingdom

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Derby, United Kingdom

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Doncaster, United Kingdom

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Dorset, United Kingdom

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Eastbourne, United Kingdom

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Hull, United Kingdom

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Leicester, United Kingdom

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Lincoln, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Mid Yorkshire, United Kingdom

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Middlesbrough, United Kingdom

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Newcastle, United Kingdom

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North Shields, United Kingdom

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Norwich, United Kingdom

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Nottingham, United Kingdom

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Oxford, United Kingdom

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Plymouth, United Kingdom

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Southampton, United Kingdom

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Stockton-on-Tees, United Kingdom

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Stoke-on-Trent, United Kingdom

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Wigan, United Kingdom

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