Study identifier:D8220R00033
ClinicalTrials.gov identifier:NCT05557695
EudraCT identifier:N/A
CTIS identifier:N/A
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).
Chronic Lymphocytic Leukemia, CLL
N/A
No
Acalabrutinib
All
350
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
UKCLL Forum
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.
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: a. To estimate real-world overall survival in patients with CLL who received acalabrutinib in the first-line. b. To describe real-world response rate to acalabrutinib in patients with CLL who received acalabrutinib in the first-line. c. To describe the healthcare resource utilisation in patients with CLL who received acalabrutinib in the first-line. d. To describe post-progression treatment patterns in patients with CLL who progressed from first-line acalabrutinib. e. To describe real-world clinical progression free survival in patients with CLL who received acalabrutinib in the first-line and progressed during acalabrutinib treatment. f. To describe acalabrutinib treatment patterns in patients with CLL who received acalabrutinib in the first-line. g. To describe baseline clinical and demographic characteristics in patients with CLL who received acalabrutinib in the first-line.
Location
Status
Location
Nottingham, United Kingdom
Status
Recruiting
Location
Oxford, United Kingdom
Status
Recruiting
Location
Middlesborough, United Kingdom
Status
Recruiting
Location
Conrnwall, United Kingdom
Status
Recruiting
Location
Aylesbury, United Kingdom
Status
Recruiting
Location
North Shields, United Kingdom
Status
Recruiting
Location
Birmingham, United Kingdom
Status
Recruiting
Location
Stoke on Trent, United Kingdom
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Group 1 Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line | - |
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