Clinical trial · Observational
Observational Study of Acalabrutinib in Patients With Chronic Lymphocytic Leukaemia in the United Kingdom
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia, CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line
- interventionNames
- Drug: Acalabrutinib
Primary outcomes (5)
- measure
- Real-world progression free survival (rwPFS)
- timeFrame
- 12 months
- description
- 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.
- measure
- Real-world progression free survival (rwPFS)
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available