Trial Title:
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
NCT ID:
NCT05557695
Condition:
Chronic Lymphocytic Leukemia, CLL
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Acalabrutinib
Conditions: Keywords:
CLL, real-world evidence, acalabrutinib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Acalabrutinib
Description:
Acalabrutinib
Arm group label:
Group 1
Other name:
Calquence
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Aylesbury
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bath
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Birmingham
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bournemouth
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cardiff
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Conrnwall
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dartford
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Derby
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Doncaster
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dorset
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Eastbourne
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hull
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Leicester
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lincoln
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Liverpool
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mid Yorkshire
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Middlesborough
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Newcastle
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
North Shields
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Norwich
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nottingham
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oxford
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Plymouth
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Southampton
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stockton on Tees
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stoke on Trent
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wigan
Country:
United Kingdom
Status:
Recruiting
Start date:
October 17, 2022
Completion date:
April 1, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
UKCLL Forum
Agency class:
Other
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557695
