Clinical trial NCT05557695: Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia, CLL
Keywords: CLL, real-world evidence, acalabrutinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: UKCLL Forum
First posted: 2022-09-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

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

Primary outcomes:
measure: Real-world progression free survival (rwPFS)
timeFrame: 12 months
measure: Real-world progression free survival (rwPFS)
timeFrame: 24 months
measure: Real-world progression free survival (rwPFS)
timeFrame: 36 months
measure: Real-world progression free survival (rwPFS)
timeFrame: 48 months
measure: Real-world progression free survival (rwPFS)
timeFrame: 60 months
Secondary outcomes:
measure: Real-world overall survival (rwOS)
timeFrame: 12 months
measure: Real-world overall survival (rwOS)
timeFrame: 24 months
measure: Real-world overall survival (rwOS)
timeFrame: 36 months
measure: Real-world overall survival (rwOS)
timeFrame: 48 months
measure: Real-world overall survival (rwOS)
timeFrame: 60 months
measure: Real-world response rate (rwRR)
timeFrame: 12 months
measure: Real-world response rate (rwRR)
timeFrame: 24 months
measure: Real-world response rate (rwRR)
timeFrame: 36 months
measure: Real-world response rate (rwRR)
timeFrame: 48 months
measure: Real-world response rate (rwRR)
timeFrame: 60 months
measure: Real-world clinical progression free survival 2 (rwPFS2)
timeFrame: 12 months
measure: Real-world clinical progression free survival 2 (rwPFS2)
timeFrame: 24 months
measure: Real-world clinical progression free survival 2 (rwPFS2)
timeFrame: 36 months
measure: Real-world clinical progression free survival 2 (rwPFS2)
timeFrame: 48 months
measure: Real-world clinical progression free survival 2 (rwPFS2)
timeFrame: 60 months
measure: Frequency of acalabrutinib dose interruptions
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Conrnwall
country: United Kingdom
facility: Research Site
city: Dartford
country: United Kingdom
facility: Research Site
city: Derby
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Dorset
country: United Kingdom
facility: Research Site
city: Eastbourne
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Lincoln
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Mid Yorkshire
country: United Kingdom
facility: Research Site
city: Middlesborough
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: North Shields
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Stockton on Tees
country: United Kingdom
facility: Research Site
city: Stoke on Trent
country: United Kingdom
facility: Research Site
city: Wigan
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
name: Toby A Eyre
role: PRINCIPAL_INVESTIGATOR
References: