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

Last updated: March 9, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Treatment

Acalabrutinib

Clinical Study ID

NCT05557695
D8220R00033
  • Ages 18-130
  • All Genders

Study 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 Criteria

Inclusion

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 UKEarly 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 beincluded in the EAP.

Exclusion

Exclusion Criteria:

  • None listed in study protocol

Study Design

Total Participants: 350
Treatment Group(s): 1
Primary Treatment: Acalabrutinib
Phase:
Study Start date:
October 17, 2022
Estimated Completion Date:
April 01, 2027

Study Description

  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.

Connect with a study center

  • Research Site

    Aylesbury,
    United Kingdom

    Active - Recruiting

  • Research Site

    Aylesbury 2656719,
    United Kingdom

    Site Not Available

  • Research Site

    Bath,
    United Kingdom

    Active - Recruiting

  • Research Site

    Bath 2656173,
    United Kingdom

    Site Not Available

  • Research Site

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Research Site

    Birmingham 2655603,
    United Kingdom

    Site Not Available

  • Research Site

    Bournemouth,
    United Kingdom

    Active - Recruiting

  • Research Site

    Bournemouth 2655095,
    United Kingdom

    Site Not Available

  • Research Site

    Cardiff,
    United Kingdom

    Active - Recruiting

  • Research Site

    Cardiff 2653822,
    United Kingdom

    Site Not Available

  • Research Site

    Conrnwall,
    United Kingdom

    Site Not Available

  • Research Site

    Cornwall,
    United Kingdom

    Active - Recruiting

  • Research Site

    Dartford,
    United Kingdom

    Active - Recruiting

  • Research Site

    Dartford 2651500,
    United Kingdom

    Site Not Available

  • Research Site

    Derby,
    United Kingdom

    Active - Recruiting

  • Research Site

    Derby 2651347,
    United Kingdom

    Site Not Available

  • Research Site

    Doncaster,
    United Kingdom

    Active - Recruiting

  • Research Site

    Doncaster 2651123,
    United Kingdom

    Site Not Available

  • Research Site

    Dorset,
    United Kingdom

    Active - Recruiting

  • Research Site

    Eastbourne,
    United Kingdom

    Active - Recruiting

  • Research Site

    Eastbourne 2650497,
    United Kingdom

    Site Not Available

  • Research Site

    Hull,
    United Kingdom

    Active - Recruiting

  • Research Site

    Hull 2645425,
    United Kingdom

    Site Not Available

  • Research Site

    Leicester,
    United Kingdom

    Active - Recruiting

  • Research Site

    Leicester 2644668,
    United Kingdom

    Site Not Available

  • Research Site

    Lincoln,
    United Kingdom

    Active - Recruiting

  • Research Site

    Lincoln 2644487,
    United Kingdom

    Site Not Available

  • Research Site

    Liverpool,
    United Kingdom

    Active - Recruiting

  • Research Site

    Liverpool 2644210,
    United Kingdom

    Site Not Available

  • Research Site

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Research Site

    London 2643743, SE1 9RT
    United Kingdom

    Site Not Available

  • Research Site

    Mid Yorkshire,
    United Kingdom

    Active - Recruiting

  • Research Site

    Middlesborough,
    United Kingdom

    Site Not Available

  • Research Site

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • Research Site

    Middlesbrough 2642607,
    United Kingdom

    Site Not Available

  • Research Site

    Newcastle,
    United Kingdom

    Active - Recruiting

  • Research Site

    Newcastle 6695976,
    United Kingdom

    Site Not Available

  • Research Site

    North Shields,
    United Kingdom

    Active - Recruiting

  • Research Site

    North Shields 2641267,
    United Kingdom

    Site Not Available

  • Research Site

    Norwich,
    United Kingdom

    Active - Recruiting

  • Research Site

    Norwich 2641181,
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Research Site

    Nottingham 2641170,
    United Kingdom

    Site Not Available

  • Research Site

    Oxford,
    United Kingdom

    Active - Recruiting

  • Research Site

    Oxford 2640729,
    United Kingdom

    Site Not Available

  • Research Site

    Plymouth,
    United Kingdom

    Active - Recruiting

  • Research Site

    Plymouth 2640194,
    United Kingdom

    Site Not Available

  • Research Site

    Southampton,
    United Kingdom

    Active - Recruiting

  • Research Site

    Southampton 2637487,
    United Kingdom

    Site Not Available

  • Research Site

    Stockton on Tees,
    United Kingdom

    Site Not Available

  • Research Site

    Stockton-on-Tees,
    United Kingdom

    Active - Recruiting

  • Research Site

    Stockton-on-Tees 2636876,
    United Kingdom

    Site Not Available

  • Research Site

    Stoke on Trent,
    United Kingdom

    Site Not Available

  • Research Site

    Stoke-on-Trent,
    United Kingdom

    Active - Recruiting

  • Research Site

    Stoke-on-Trent 2636841,
    United Kingdom

    Site Not Available

  • Research Site

    Truro,
    United Kingdom

    Site Not Available

  • Research Site

    Wigan,
    United Kingdom

    Active - Recruiting

  • Research Site

    Wigan 2633948,
    United Kingdom

    Site Not Available

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