Chronic Lymphocytic Leukemia, CLLEPICNCT05557695
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
An observational study of Chronic Lymphocytic Leukemia, CLL, run by AstraZeneca at 29 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia, CLL
- What is being tested?
- Acalabrutinib
- How many people
- 287 participants
- Where
- 29 sitesUnited Kingdom
- Study dates
- 17 Oct 2022to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- None listed in study protocol
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
29 sites in 1 country
United Kingdom29 sites, 29 recruiting
- Recruiting
Research Site
Aylesbury
- Recruiting
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Bath
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Birmingham
- Recruiting
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Bournemouth
- Recruiting
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Cardiff
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Cornwall
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Dartford
- Recruiting
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Derby
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Doncaster
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Dorset
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Eastbourne
- Recruiting
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Hull
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Leicester
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Lincoln
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Liverpool
- Recruiting
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London, SE1 9RT
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London, W12 OHS
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Mid Yorkshire
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Middlesbrough
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Newcastle
- Recruiting
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North Shields
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Norwich
- Recruiting
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Nottingham
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Oxford
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Plymouth
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Southampton
- Recruiting
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Stockton-on-Tees
- Recruiting
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Stoke-on-Trent
- Recruiting
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Wigan
About this study
Official title: 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.
Read the detailed description
- Primary Objectives:
- To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line.
- Secondary Objectives:
- To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line.
- To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line.
- To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line.
- To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib.
- To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment.
- To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line.
- To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.
- Conditions
- Chronic Lymphocytic Leukemia, CLL
- Being tested
- Acalabrutinib
- Keywords
- CLL, real-world evidence, acalabrutinib
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Also called Calquence
Acalabrutinib
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line Receives: Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world progression free survival (rwPFS)
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.
Measured: 12 months
Real-world progression free survival (rwPFS)
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.
Measured: 24 months
Real-world progression free survival (rwPFS)
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.
Measured: 36 months
Real-world progression free survival (rwPFS)
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.
Measured: 48 months
Real-world progression free survival (rwPFS)
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.
Measured: 60 months
Secondary outcomes (16)
Real-world overall survival (rwOS)
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).
Measured: 12 months
Real-world overall survival (rwOS)
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).
Measured: 24 months
Real-world overall survival (rwOS)
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).
Measured: 36 months
Real-world overall survival (rwOS)
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).
Measured: 48 months
Real-world overall survival (rwOS)
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).
Measured: 60 months
Real-world response rate (rwRR)
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.
Measured: 12 months
Real-world response rate (rwRR)
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.
Measured: 24 months
Real-world response rate (rwRR)
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.
Measured: 36 months
Real-world response rate (rwRR)
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.
Measured: 48 months
Real-world response rate (rwRR)
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.
Measured: 60 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Measured: 12 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Measured: 24 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Measured: 36 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Measured: 48 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Measured: 60 months
Frequency of acalabrutinib dose interruptions
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).
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start17 Oct 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia, CLLStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 287 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UKCLL Forum
- Responsible party
- Sponsor
- Investigators
- Toby A Eyre, Principal investigator, Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557695
- Sponsor's protocol ID
- D8220R00033
- Acronym
- EPIC
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT05557695
- Acronym / sponsor ID
- EPIC / D8220R00033
- Conditions
- Chronic Lymphocytic Leukemia, CLL
- Keywords
- CLL, real-world evidence, acalabrutinib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- UKCLL Forum
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary Objectives:
- To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line.
- Secondary Objectives:
- To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line.
- To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line.
- To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line.
- To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib.
- To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment.
- To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line.
- To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: AcalabrutinibPatients with chronic lymphocytic leukaemia treated with acalabrutinib in first line |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None listed in study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibAlso: CalquenceAcalabrutinib | Drug | Group 1 |
Primary outcome
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.
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.
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.
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.
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.
16 secondary outcomes
Real-world overall survival (rwOS)
Time frame: 12 months
Real-world overall survival (rwOS)
Time frame: 24 months
Real-world overall survival (rwOS)
Time frame: 36 months
Real-world overall survival (rwOS)
Time frame: 48 months
Real-world overall survival (rwOS)
Time frame: 60 months
Real-world response rate (rwRR)
Time frame: 12 months
Real-world response rate (rwRR)
Time frame: 24 months
Real-world response rate (rwRR)
Time frame: 36 months
Real-world response rate (rwRR)
Time frame: 48 months
Real-world response rate (rwRR)
Time frame: 60 months
Real-world clinical progression free survival 2 (rwPFS2)
Time frame: 12 months
Real-world clinical progression free survival 2 (rwPFS2)
Time frame: 24 months
Real-world clinical progression free survival 2 (rwPFS2)
Time frame: 36 months
Real-world clinical progression free survival 2 (rwPFS2)
Time frame: 48 months
Real-world clinical progression free survival 2 (rwPFS2)
Time frame: 60 months
Frequency of acalabrutinib dose interruptions
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Toby A Eyre principal investigator
Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, CLL, run by AstraZeneca at 29 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world progression free survival (rwPFS) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.