NCT05557695

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

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).

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Lymphocytic Leukemia, CLL

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib

Timeline

• Start date: 2022-10-17
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-09-28
• Last updated: 2026-03-10

Locations

29 sites across 1 country: United Kingdom