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

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on how patients with chronic lymphocytic leukemia (CLL) in the UK responded to acalabrutinib (a targeted therapy) when it was provided through an early access program before full approval. It aims to understand long-term outcomes and safety in a real clinical setting. **You may be eligible if:** - You have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) - You had not previously received treatment for CLL when you started acalabrutinib - You received your first dose between April 2020 and April 2021 through the UK Early Access Programme - You are 18 or older **You may NOT be eligible if:** - There are no formal exclusion criteria listed for this observational study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Acalabrutinib


Locations(29)

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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Liverpool, 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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NCT05557695


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