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

NCT ID: NCT05557695

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-17

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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1. Primary Objectives:

a. To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line.
2. Secondary Objectives:

1. To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line.
2. To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line.
3. To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line.
4. To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib.
5. To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment.
6. To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line.
7. To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.

Conditions

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Chronic Lymphocytic Leukemia, CLL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line

Acalabrutinib

Intervention Type DRUG

Acalabrutinib

Interventions

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Acalabrutinib

Acalabrutinib

Intervention Type DRUG

Other Intervention Names

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Calquence

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UKCLL Forum

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toby A Eyre

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK

Locations

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Research Site

Aylesbury, , United Kingdom

Site Status RECRUITING

Research Site

Bath, , United Kingdom

Site Status RECRUITING

Research Site

Birmingham, , United Kingdom

Site Status RECRUITING

Research Site

Bournemouth, , United Kingdom

Site Status RECRUITING

Research Site

Cardiff, , United Kingdom

Site Status RECRUITING

Research Site

Cornwall, , United Kingdom

Site Status RECRUITING

Research Site

Dartford, , United Kingdom

Site Status RECRUITING

Research Site

Derby, , United Kingdom

Site Status RECRUITING

Research Site

Doncaster, , United Kingdom

Site Status RECRUITING

Research Site

Dorset, , United Kingdom

Site Status RECRUITING

Research Site

Eastbourne, , United Kingdom

Site Status RECRUITING

Research Site

Hull, , United Kingdom

Site Status RECRUITING

Research Site

Leicester, , United Kingdom

Site Status RECRUITING

Research Site

Lincoln, , United Kingdom

Site Status RECRUITING

Research Site

Liverpool, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

Mid Yorkshire, , United Kingdom

Site Status RECRUITING

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Middlesbrough, , United Kingdom

Site Status RECRUITING

Research Site

Newcastle, , United Kingdom

Site Status RECRUITING

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North Shields, , United Kingdom

Site Status RECRUITING

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Norwich, , United Kingdom

Site Status RECRUITING

Research Site

Nottingham, , United Kingdom

Site Status RECRUITING

Research Site

Oxford, , United Kingdom

Site Status RECRUITING

Research Site

Plymouth, , United Kingdom

Site Status RECRUITING

Research Site

Southampton, , United Kingdom

Site Status RECRUITING

Research Site

Stockton-on-Tees, , United Kingdom

Site Status RECRUITING

Research Site

Stoke-on-Trent, , United Kingdom

Site Status RECRUITING

Research Site

Wigan, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D8220R00033

Identifier Type: -

Identifier Source: org_study_id

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