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

September 7, 2026 updated by: AstraZeneca

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Aylesbury, United Kingdom
        • Recruiting
        • Research Site
      • Bath, United Kingdom
        • Recruiting
        • Research Site
      • Birmingham, United Kingdom
        • Recruiting
        • Research Site
      • Bournemouth, United Kingdom
        • Recruiting
        • Research Site
      • Cardiff, United Kingdom
        • Recruiting
        • Research Site
      • Cornwall, United Kingdom
        • Recruiting
        • Research Site
      • Dartford, United Kingdom
        • Recruiting
        • Research Site
      • Derby, United Kingdom
        • Recruiting
        • Research Site
      • Doncaster, United Kingdom
        • Recruiting
        • Research Site
      • Dorset, United Kingdom
        • Recruiting
        • Research Site
      • Eastbourne, United Kingdom
        • Recruiting
        • Research Site
      • Hull, United Kingdom
        • Recruiting
        • Research Site
      • Leicester, United Kingdom
        • Recruiting
        • Research Site
      • Lincoln, United Kingdom
        • Recruiting
        • Research Site
      • Liverpool, United Kingdom
        • Recruiting
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Research Site
      • London, United Kingdom, W12 OHS
        • Recruiting
        • Research Site
      • Mid Yorkshire, United Kingdom
        • Recruiting
        • Research Site
      • Middlesbrough, United Kingdom
        • Recruiting
        • Research Site
      • Newcastle, United Kingdom
        • Recruiting
        • Research Site
      • North Shields, United Kingdom
        • Recruiting
        • Research Site
      • Norwich, United Kingdom
        • Recruiting
        • Research Site
      • Nottingham, United Kingdom
        • Recruiting
        • Research Site
      • Oxford, United Kingdom
        • Recruiting
        • Research Site
      • Plymouth, United Kingdom
        • Recruiting
        • Research Site
      • Southampton, United Kingdom
        • Recruiting
        • Research Site
      • Stockton-on-Tees, United Kingdom
        • Recruiting
        • Research Site
      • Stoke-on-Trent, United Kingdom
        • Recruiting
        • Research Site
      • Wigan, United Kingdom
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Treatment-naïve adults (≥18 years old) with chronic lymphocytic lymphoma (CLL) who were initiated on acalabrutinib as part of the UK acalabrutiinib early access programme and received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line
Drug: Acalabrutinib
Acalabrutinib
Other Names:
  • Calquence

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Real-world progression free survival (rwPFS)
Time Frame: 12 months
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
12 months
Real-world progression free survival (rwPFS)
Time Frame: 24 months
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
24 months
Real-world progression free survival (rwPFS)
Time Frame: 36 months
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
36 months
Real-world progression free survival (rwPFS)
Time Frame: 48 months
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
48 months
Real-world progression free survival (rwPFS)
Time Frame: 60 months
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Real-world overall survival (rwOS)
Time Frame: 12 months
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
12 months
Real-world overall survival (rwOS)
Time Frame: 24 months
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
24 months
Real-world overall survival (rwOS)
Time Frame: 36 months
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
36 months
Real-world overall survival (rwOS)
Time Frame: 48 months
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
48 months
Real-world overall survival (rwOS)
Time Frame: 60 months
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
60 months
Real-world response rate (rwRR)
Time Frame: 12 months
rwRR will be defined as the proportion of patients with a recorded significant anti-cancer response and will be defined here as the sum of complete response, partial response and partial response + lymphocytosis. Response will be based on the on the documented assessment of the local investigator.
12 months
Real-world response rate (rwRR)
Time Frame: 24 months
rwRR will be defined as the proportion of patients with a recorded significant anti-cancer response and will be defined here as the sum of complete response, partial response and partial response + lymphocytosis. Response will be based on the on the documented assessment of the local investigator.
24 months
Real-world response rate (rwRR)
Time Frame: 36 months
rwRR will be defined as the proportion of patients with a recorded significant anti-cancer response and will be defined here as the sum of complete response, partial response and partial response + lymphocytosis. Response will be based on the on the documented assessment of the local investigator.
36 months
Real-world response rate (rwRR)
Time Frame: 48 months
rwRR will be defined as the proportion of patients with a recorded significant anti-cancer response and will be defined here as the sum of complete response, partial response and partial response + lymphocytosis. Response will be based on the on the documented assessment of the local investigator.
48 months
Real-world response rate (rwRR)
Time Frame: 60 months
rwRR will be defined as the proportion of patients with a recorded significant anti-cancer response and will be defined here as the sum of complete response, partial response and partial response + lymphocytosis. Response will be based on the on the documented assessment of the local investigator.
60 months
Real-world clinical progression free survival 2 (rwPFS2)
Time Frame: 12 months
rwPFS2 will be defined as the time from index date to the date of the second record of real-world progression (as determined by physicians' assessment) or death due to any cause (if no progression), whichever occurs first whilst on second line treatment. If there is no second progression or the patient is lost to follow-up, PFS2 will be censored at the time of the last available tumour assessment.
12 months
Real-world clinical progression free survival 2 (rwPFS2)
Time Frame: 24 months
rwPFS2 will be defined as the time from index date to the date of the second record of real-world progression (as determined by physicians' assessment) or death due to any cause (if no progression), whichever occurs first whilst on second line treatment. If there is no second progression or the patient is lost to follow-up, PFS2 will be censored at the time of the last available tumour assessment.
24 months
Real-world clinical progression free survival 2 (rwPFS2)
Time Frame: 36 months
rwPFS2 will be defined as the time from index date to the date of the second record of real-world progression (as determined by physicians' assessment) or death due to any cause (if no progression), whichever occurs first whilst on second line treatment. If there is no second progression or the patient is lost to follow-up, PFS2 will be censored at the time of the last available tumour assessment.
36 months
Real-world clinical progression free survival 2 (rwPFS2)
Time Frame: 48 months
rwPFS2 will be defined as the time from index date to the date of the second record of real-world progression (as determined by physicians' assessment) or death due to any cause (if no progression), whichever occurs first whilst on second line treatment. If there is no second progression or the patient is lost to follow-up, PFS2 will be censored at the time of the last available tumour assessment.
48 months
Real-world clinical progression free survival 2 (rwPFS2)
Time Frame: 60 months
rwPFS2 will be defined as the time from index date to the date of the second record of real-world progression (as determined by physicians' assessment) or death due to any cause (if no progression), whichever occurs first whilst on second line treatment. If there is no second progression or the patient is lost to follow-up, PFS2 will be censored at the time of the last available tumour assessment.
60 months
Frequency of acalabrutinib dose interruptions
Time Frame: Through study completion, an average of 5 years
A treatment interruption will be defined as clinician or patient-initiated temporary treatment cessation of acalabrutinib, where treatment is known to have been recommenced at any time within the observation window (without initiation on a different systemic treatment for CLL in the intervening period).
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UKCLL Forum

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Toby A Eyre, Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8220R00033

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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