RecruitingOBSERVATIONAL

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

This study, called EPIC, is looking back at the real-world experiences of people in the UK with Chronic Lymphocytic Leukaemia (CLL) who received the medicine acalabrutinib. Participants were part of an Early Access Programme, meaning they were among the first to get this treatment in the UK. Researchers are collecting information from patient records to understand how people with CLL responded to acalabrutinib when it was their first treatment. This includes looking at how long the treatment worked, how long people lived, and what other care they needed. The goal is to gather valuable information about acalabrutinib's effectiveness in a real UK healthcare setting.

At a glance

Status

Recruiting

Sponsor

AstraZeneca

Enrolment target

350

Start

17 Oct 2022

Estimated completion

01 Apr 2027

Chronic Lymphocytic Leukemia, CLL

What is this study about?

This study, called EPIC, aims to understand how a medicine called acalabrutinib works for people in the UK who have a type of blood cancer called Chronic Lymphocytic Leukaemia (CLL). It's an "observational" study, which means researchers are looking back at information that has already been collected, rather than asking people to do new things. They are gathering details from the medical records of patients who were given acalabrutinib as part of the UK's Early Access Programme (EAP).

The Early Access Programme allowed eligible patients to receive acalabrutinib before it was widely available. By studying these patient records, researchers hope to get a clear picture of how effective acalabrutinib was as a first treatment for CLL in a real-world setting. This includes how long people stayed well without their cancer getting worse, how long they lived, and what other medical care they needed.

Ultimately, the information from this study will help doctors and healthcare providers better understand acalabrutinib's impact on CLL patients in the UK. It provides valuable insights that aren't always captured in traditional clinical trials, as it reflects everyday patient care and experiences.

Key takeaways

This study looks back at how acalabrutinib worked for UK CLL patients.
It uses existing medical records from an Early Access Programme, so no patient involvement is needed.
The aim is to understand real-world treatment outcomes for CLL in the UK.
Data includes how long treatment worked and overall patient survival.
Information gathered will help improve future CLL patient care in the UK.

Who may be eligible?

This study is looking at information from people who previously received acalabrutinib. To be included, individuals must have been diagnosed with Chronic Lymphocytic Leukaemia (CLL) and started acalabrutinib as their very first treatment for CLL, through the UK Early Access Programme.

They must have received their first dose of acalabrutinib between 1st April 2020 and 1st April 2021, and have been 18 years old or older at that time. Even if someone later found out they had a similar condition called Small Lymphocytic Lymphoma (SLL), their information might still be included if they met the other criteria.

There were no specific reasons to exclude patients from this review, meaning the study intends to include all suitable patient records from the Early Access Programme that met the starting criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Were you diagnosed with Chronic Lymphocytic Leukaemia (CLL)?
Did you take acalabrutinib as your very first treatment for CLL?
Did you start acalabrutinib between 1st April 2020 and 1st April 2021?
Were you aged 18 or older when you started acalabrutinib?

Answer every question to see your result.

What does participation involve?

As this is an observational study looking at existing medical records, there will be no direct involvement required from patients. You will not need to attend any extra appointments, take new medication, or undergo any additional tests. Your doctor or clinic will be invited to share depersonalised information from your medical records, and this will be done in line with all local privacy laws. The study duration involves reviewing past records, so there are no ongoing requirements for individuals.

Potential risks and benefits

Because this study only reviews existing, anonymised medical records, there are no direct risks to patients involved. Your personal identifiable information will be protected. The main benefit is that the information gathered will help doctors and researchers in the UK better understand how acalabrutinib works for people with CLL in a real-world setting. This knowledge can improve future treatment decisions and patient care. As an observational study, you will not be able to withdraw your data once it has been included and anonymised.

Locations (29)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
Verified postcode
Aylesbury, United Kingdom· Recruiting
Research Site
Verified postcode
Bath, United Kingdom· Recruiting
Research Site
Verified postcode
Birmingham, United Kingdom· Recruiting
Research Site
Verified postcode
Bournemouth, United Kingdom· Recruiting
Research Site
Verified postcode
Cardiff, United Kingdom· Recruiting
Research Site
Unverified
Cornwall, United Kingdom· Recruiting
Research Site
Verified postcode
Dartford, United Kingdom· Recruiting
Research Site
Verified postcode
Derby, United Kingdom· Recruiting
Research Site
Verified postcode
Doncaster, United Kingdom· Recruiting
Research Site
Unverified
Dorset, United Kingdom· Recruiting
Research Site
Verified postcode
Eastbourne, United Kingdom· Recruiting
Research Site
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is Chronic Lymphocytic Leukaemia (CLL)?

CLL is a slow-growing type of cancer that affects white blood cells, specifically lymphocytes, in the blood and bone marrow.

What is acalabrutinib?

Acalabrutinib is a medicine used to treat certain types of blood cancer, including CLL.

What does 'Early Access Programme' mean?

It means patients were able to get this medication before it was widely available to everyone in the UK, often for serious conditions where there's a high medical need.

Will I have to do anything if my data is used?

No, this study only reviews existing medical records. You won't need to do anything or attend extra appointments.

How will my privacy be protected?

Researchers will only use information from your records that does not directly identify you, and all data handling will follow strict privacy laws.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.