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| Name | Class |
|---|---|
| UKCLL Forum | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients with chronic lymphocytic leukaemia treated with acalabrutinib in first line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Real-world overall survival (rwOS) |
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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
Exclusion Criteria:
- None listed in study protocol
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| Toby A Eyre | Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Aylesbury | United Kingdom | |||
| Research Site |
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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).
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | Through study completion, an average of 5 years |
| Recruiting |
| Bath |
| United Kingdom |
| Research Site | Recruiting | Birmingham | United Kingdom |
| Research Site | Recruiting | Bournemouth | United Kingdom |
| Research Site | Recruiting | Cardiff | United Kingdom |
| Research Site | Recruiting | Cornwall | United Kingdom |
| Research Site | Recruiting | Dartford | United Kingdom |
| Research Site | Recruiting | Derby | United Kingdom |
| Research Site | Recruiting | Doncaster | United Kingdom |
| Research Site | Recruiting | Dorset | United Kingdom |
| Research Site | Recruiting | Eastbourne | United Kingdom |
| Research Site | Recruiting | Hull | United Kingdom |
| Research Site | Recruiting | Leicester | United Kingdom |
| Research Site | Recruiting | Lincoln | United Kingdom |
| Research Site | Recruiting | Liverpool | United Kingdom |
| Research Site | Recruiting | London | SE1 9RT | United Kingdom |
| Research Site | Recruiting | London | W12 OHS | United Kingdom |
| Research Site | Recruiting | Mid Yorkshire | United Kingdom |
| Research Site | Recruiting | Middlesbrough | United Kingdom |
| Research Site | Recruiting | Newcastle | United Kingdom |
| Research Site | Recruiting | North Shields | United Kingdom |
| Research Site | Recruiting | Norwich | United Kingdom |
| Research Site | Recruiting | Nottingham | United Kingdom |
| Research Site | Recruiting | Oxford | United Kingdom |
| Research Site | Recruiting | Plymouth | United Kingdom |
| Research Site | Recruiting | Southampton | United Kingdom |
| Research Site | Recruiting | Stockton-on-Tees | United Kingdom |
| Research Site | Recruiting | Stoke-on-Trent | United Kingdom |
| Research Site | Recruiting | Wigan | United Kingdom |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000604908 | acalabrutinib |
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