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

February 14, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

350

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 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
      • Conrnwall, 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
      • Lincoln, United Kingdom
        • Recruiting
        • Research Site
      • Liverpool, United Kingdom
        • Recruiting
        • Research Site
      • London, United Kingdom
        • Recruiting
        • Research Site
      • Mid Yorkshire, United Kingdom
        • Recruiting
        • Research Site
      • Middlesborough, 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

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
Intervention / Treatment
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

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

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

AstraZeneca

Collaborators

UKCLL Forum

Investigators

  • 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)

October 17, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Chronic Lymphocytic Leukemia, CLL

Clinical Trials on Acalabrutinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe