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

AstraZeneca

Status: Enrolling

Conditions: Chronic Lymphocytic Leukemia, CLL

Treatments: Drug: Acalabrutinib

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05557695

D8220R00033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

350 participants in 1 patient group

Group 1

Description:

Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line

Treatment:

Drug: Acalabrutinib