NCT05557695 Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
| NCT ID | NCT05557695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Chronic Lymphocytic Leukemia, CLL |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-10-17 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2022-10-17 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Toby A Eyre
PRINCIPAL INVESTIGATOR
Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Frequently Asked Questions
Who can join the NCT05557695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Chronic Lymphocytic Leukemia, CLL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05557695 currently recruiting?
Yes, NCT05557695 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT05557695 trial being conducted?
This trial is being conducted at Aylesbury, United Kingdom, Bath, United Kingdom, Birmingham, United Kingdom, Bournemouth, United Kingdom and 11 additional locations.
Who is sponsoring the NCT05557695 clinical trial?
NCT05557695 is sponsored by AstraZeneca. The principal investigator is Toby A Eyre at Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. The trial plans to enroll 350 participants.
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