Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2020-12-23
Brief Title:
ALICIA Acalabrutinib in CLL Therapy
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
ALICIA Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALICIA
Brief Summary:
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data In this study commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physicians best clinical judgement No additional procedures besides those already used in the routine clinical practice will be applied to the patients Treatment assignment will be done according to the current practice
A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database rather than limiting the data to a single institution This will be critical for
increasing database sample size
reducing bias single institution bias
increasing results generalizability to the whole Russian population Being an observational study only data available from routine clinical practice and standard of care SoC in line with national and international laws and regulations will be recorded
Patients will be treated according to prescribing information with visit frequency and assessments performed according to routine medical practice and SoC Only data corresponding to these visits and assessments will be collected as part of the study
Data for the study will be transcribed and entered into an electronic Case Report Form eCRF from the patients medical records The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization
A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database rather than limiting the data to a single institution This will be critical for
increasing database sample size
reducing bias single institution bias
increasing results generalizability to the whole Russian population Being an observational study only data available from routine clinical practice and standard of care SoC in line with national and international laws and regulations will be recorded
Patients will be treated according to prescribing information with visit frequency and assessments performed according to routine medical practice and SoC Only data corresponding to these visits and assessments will be collected as part of the study
Data for the study will be transcribed and entered into an electronic Case Report Form eCRF from the patients medical records The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None