Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170671
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-12-06
Brief Title:
REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Observational Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania
Status:
RECRUITING
Status Verified Date:
2024-10
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:
REACH
Brief Summary:
Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients either as monotherapy or in combination with obinutuzumab in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023 In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives reasons for discontinuation effectiveness of acalabrutinib in real-life practice baseline clinical and demographic characteristics treatment patterns and major determinants of treatment discontinuation The study will retrospectively collect longitudinal data from 250 patients at national levelat pre-defined timepoints for 3 years from 2 sequential cohorts1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year
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