Acalabrutinib
DrugAcalabrutinib
Other names: Calquence
NCT Number: NCT05557695
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.
Interested in participating?
Request Info18 year–130 year
All sexes
Observational
Research Site, Aylesbury, United Kingdom
a. To estimate real-world progression-free survival in patients with CLL who received acalabrutinib in the first-line.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
The study population will include treatment-naïve patients with chronic lymphocytic lymphoma (CLL)* who meet the following inclusion criteria:
Exclusion criteria
Acalabrutinib
Other names: Calquence
Time frame: 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.
Time frame: 24 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.
Time frame: 36 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.
Time frame: 48 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.
Time frame: 60 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.
Time frame: 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).
Time frame: 24 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).
Time frame: 36 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).
Time frame: 48 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).
Time frame: 60 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).
Time frame: 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.
Time frame: 24 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.
Time frame: 36 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.
Time frame: 48 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.
Time frame: 60 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.
Time frame: 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.
Time frame: 24 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.
Time frame: 36 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.
Time frame: 48 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.
Time frame: 60 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
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).
Acronym: EPIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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