An observational study in Chronic Lymphocytic Leukemia, CLL, sponsored by AstraZeneca. Recruiting at 29 sites in United Kingdom. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by AstraZeneca · Observational
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.
Primary Objectives:
a. To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line.
Secondary Objectives:
190 studies on the registry are indexed under Leukemia, B-Cell; 52 are open to participants now.
This study's planned enrollment of 287 is above the median of 120 across 22 observational studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
The study population will include treatment-naïve patients with chronic lymphocytic lymphoma (CLL)* who meet the following inclusion criteria:
Patients aged ≥18 years old
Exclusion Criteria:
- None listed in study protocol
Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line
Drug: Acalabrutinib
Acalabrutinib
Also known as: Calquence
Real-world progression free survival (rwPFS)
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.
Time frame: 12 months
Real-world progression free survival (rwPFS)
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.
Time frame: 24 months
Real-world progression free survival (rwPFS)
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.
Time frame: 36 months
Real-world progression free survival (rwPFS)
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.
Time frame: 48 months
Real-world progression free survival (rwPFS)
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.
Time frame: 60 months
Real-world overall survival (rwOS)
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).
Time frame: 12 months
Real-world overall survival (rwOS)
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).
Time frame: 24 months
Real-world overall survival (rwOS)
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).
Time frame: 36 months
Real-world overall survival (rwOS)
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).
Time frame: 48 months
Real-world overall survival (rwOS)
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).
Time frame: 60 months
Real-world response rate (rwRR)
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.
Time frame: 12 months
Real-world response rate (rwRR)
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.
Time frame: 24 months
Real-world response rate (rwRR)
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.
Time frame: 36 months
Real-world response rate (rwRR)
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.
Time frame: 48 months
Real-world response rate (rwRR)
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.
Time frame: 60 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Time frame: 12 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Time frame: 24 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Time frame: 36 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Time frame: 48 months
Real-world clinical progression free survival 2 (rwPFS2)
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.
Time frame: 60 months
Frequency of acalabrutinib dose interruptions
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).
Time frame: Through study completion, an average of 5 years
Started Oct 2022 (actual). Primary completion is estimated for Apr 2027, 53 months after the start.
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