Chronic Lymphocytic Leukemia, CLL
Conditions
Keywords
CLL, real-world evidence, acalabrutinib
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.
Interventions
DRUGAcalabrutinib
Acalabrutinib
Sponsors
AstraZeneca
UKCLL Forum
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-world progression free survival (rwPFS) | 12 months | rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world overall survival (rwOS) | 12 months | rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations). |
| Real-world response rate (rwRR) | 12 months | rwRR will be defined as the proportion of patients with a recorded significant anti-cancer response and will be defined here as the sum of complete response, partial response and partial response + lymphocytosis. Response will be based on the on the documented assessment of the local investigator. |
| Real-world clinical progression free survival 2 (rwPFS2) | 12 months | rwPFS2 will be defined as the time from index date to the date of the second record of real-world progression (as determined by physicians' assessment) or death due to any cause (if no progression), whichever occurs first whilst on second line treatment. If there is no second progression or the patient is lost to follow-up, PFS2 will be censored at the time of the last available tumour assessment. |
| Frequency of acalabrutinib dose interruptions | Through study completion, an average of 5 years | A treatment interruption will be defined as clinician or patient-initiated temporary treatment cessation of acalabrutinib, where treatment is known to have been recommenced at any time within the observation window (without initiation on a different systemic treatment for CLL in the intervening period). |
Countries
United Kingdom
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORToby A Eyre
Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Outcome results
None listed