Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acalabrutinib.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, CLL. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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).
Overview
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.
Interventions
- Drug Acalabrutinib
Acalabrutinib
Primary outcome measures
- Real-world progression free survival (rwPFS) [Time frame: 12 months]
- Real-world progression free survival (rwPFS) [Time frame: 24 months]
- Real-world progression free survival (rwPFS) [Time frame: 36 months]
- Real-world progression free survival (rwPFS) [Time frame: 48 months]
- Real-world progression free survival (rwPFS) [Time frame: 60 months]
Secondary outcome measures (12)
- Real-world overall survival (rwOS) [Time frame: 12 months]
- Real-world overall survival (rwOS) [Time frame: 24 months]
- Real-world overall survival (rwOS) [Time frame: 36 months]
- Real-world overall survival (rwOS) [Time frame: 48 months]
- Real-world overall survival (rwOS) [Time frame: 60 months]
- Real-world response rate (rwRR) [Time frame: 12 months]
- Real-world response rate (rwRR) [Time frame: 24 months]
- Real-world response rate (rwRR) [Time frame: 36 months]
- Real-world response rate (rwRR) [Time frame: 48 months]
- Real-world response rate (rwRR) [Time frame: 60 months]
- Real-world clinical progression free survival 2 (rwPFS2) [Time frame: 12 months]
- Real-world clinical progression free survival 2 (rwPFS2) [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 29 centers
- Research Site — Aylesbury
- Research Site — Bath
- Research Site — Birmingham
- Research Site — Bournemouth
- Research Site — Cardiff
- Research Site — Cornwall
- Research Site — Dartford
- Research Site — Derby
- … and 21 more centers
Identifiers
NCT: NCT05557695 · D8220R00033