Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2025-12-17 @ 4:43 AM
Study NCT ID:
NCT06205498
Status:
None
Last Update Posted:
2025-08-22 00:00:00
First Post:
2023-07-06 00:00:00
Brief Title:
Acalabrutinib Real World Italian obSErvational Study -ARISE
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Acalabrutinib Real World Italian obSErvational Secondary Data Collection Study of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia.
Status:
None
Status Verified Date:
2025-08
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:
ARISE
Brief Summary:
Study design:
This is an Italian non-interventional / observational, multicenter, longitudinal secondary data usage study based on a retrospective cohort of patients with CLL, who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 (index date), regardless of the treatment status at the time of inclusion. Each patient will be followed-up up to 5 years since the last enrolled patient index date (therefore for a maximum of 72 months). Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients' medical records and data entry into the electronic case report form (eCRFs).
Data Source(s):
Source documents (paper or electronic) are those in which patient data are recorded and documented for the first time as part of patients' path of care (e.g., patient's hospital records, pharmacy dispensing records).
A standardized, validated eCRF will be developed to capture data extracted from source documents at each participating site.
Study Population:
All consecutive adult patients with CLL who initiated treatment with acalabrutinib over the period between 1st May 2021 and 30th April 2022, according to Italian legislation dlg 219/2006 art.125.
Outcome(s):
The primary outcome is the time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment).
Secondary outcomes include: Time from diagnosis to start of acalabrutinib, immunophenotype, CLL clinical stage (Binet), FISH profile, mutations, karyotype, CLL treatments before acalabrutinib, socio-demographic characteristics at baseline, medical history, concomitant treatments, COVID-19 prophylaxis and treatments, constitutional symptoms, patient clinical status, ECG/TTE, complete blood count with differential, serum chemistry, HIV and Hepatitis serology, active haemolysis, time to acalabrutinib discontinuation, acalabrutinib treatment (dosage, relative changes, temporary interruption/permanent discontinuation).
Exploratory outcomes include: Time to progression, Time to death, CLL status (according to iwCLL), Time to Next Treatment, Time to progression on next line treatment, reasons for ending of CLL treatments following acalabrutinib discontinuation, visits and hospitalizations due to CLL or suspected ADR during acalabrutinib treatment.
This is an Italian non-interventional / observational, multicenter, longitudinal secondary data usage study based on a retrospective cohort of patients with CLL, who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 (index date), regardless of the treatment status at the time of inclusion. Each patient will be followed-up up to 5 years since the last enrolled patient index date (therefore for a maximum of 72 months). Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients' medical records and data entry into the electronic case report form (eCRFs).
Data Source(s):
Source documents (paper or electronic) are those in which patient data are recorded and documented for the first time as part of patients' path of care (e.g., patient's hospital records, pharmacy dispensing records).
A standardized, validated eCRF will be developed to capture data extracted from source documents at each participating site.
Study Population:
All consecutive adult patients with CLL who initiated treatment with acalabrutinib over the period between 1st May 2021 and 30th April 2022, according to Italian legislation dlg 219/2006 art.125.
Outcome(s):
The primary outcome is the time to acalabrutinib discontinuation (defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment).
Secondary outcomes include: Time from diagnosis to start of acalabrutinib, immunophenotype, CLL clinical stage (Binet), FISH profile, mutations, karyotype, CLL treatments before acalabrutinib, socio-demographic characteristics at baseline, medical history, concomitant treatments, COVID-19 prophylaxis and treatments, constitutional symptoms, patient clinical status, ECG/TTE, complete blood count with differential, serum chemistry, HIV and Hepatitis serology, active haemolysis, time to acalabrutinib discontinuation, acalabrutinib treatment (dosage, relative changes, temporary interruption/permanent discontinuation).
Exploratory outcomes include: Time to progression, Time to death, CLL status (according to iwCLL), Time to Next Treatment, Time to progression on next line treatment, reasons for ending of CLL treatments following acalabrutinib discontinuation, visits and hospitalizations due to CLL or suspected ADR during acalabrutinib treatment.
Detailed Description:
Study design
This is an Italian non-interventional observational multicenter longitudinal secondary data usage study based on a retrospective cohort of patients with CLL who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 index date regardless of the treatment status at the time of inclusion Each patient will be followed-up up to 5 years since the last enrolled patient index date therefore for a maximum of 72 months Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients medical records and data entry into the electronic case report form eCRFs
Data Sources
Source documents paper or electronic are those in which patient data are recorded and documented for the first time as part of patients path of care eg patients hospital records pharmacy dispensing records
A standardized validated eCRF will be developed to capture data extracted from source documents at each participating site
Study Population
All consecutive adult patients with CLL who initiated treatment with acalabrutinib over the period between 1st May 2021 and 30th April 2022 according to Italian legislation dlg 2192006 art125
Outcomes
The primary outcome is the time to acalabrutinib discontinuation defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment
Secondary outcomes include Time from diagnosis to start of acalabrutinib immunophenotype CLL clinical stage Binet FISH profile mutations karyotype CLL treatments before acalabrutinib socio-demographic characteristics at baseline medical history concomitant treatments COVID-19 prophylaxis and treatments constitutional symptoms patient clinical status ECGTTE complete blood count with differential serum chemistry HIV and Hepatitis serology active haemolysis time to acalabrutinib discontinuation acalabrutinib treatment dosage relative changes temporary interruptionpermanent discontinuation
Exploratory outcomes include Time to progression Time to death CLL status according to iwCLL Time to Next Treatment Time to progression on next line treatment reasons for ending of CLL treatments following acalabrutinib discontinuation visits and hospitalizations due to CLL or suspected ADR during acalabrutinib treatment
This is an Italian non-interventional observational multicenter longitudinal secondary data usage study based on a retrospective cohort of patients with CLL who initiated treatment with acalabrutinib between 1st May 2021 and 30th April 2022 index date regardless of the treatment status at the time of inclusion Each patient will be followed-up up to 5 years since the last enrolled patient index date therefore for a maximum of 72 months Five data extraction timepoints are planned for the investigators to proceed with secondary data extraction from patients medical records and data entry into the electronic case report form eCRFs
Data Sources
Source documents paper or electronic are those in which patient data are recorded and documented for the first time as part of patients path of care eg patients hospital records pharmacy dispensing records
A standardized validated eCRF will be developed to capture data extracted from source documents at each participating site
Study Population
All consecutive adult patients with CLL who initiated treatment with acalabrutinib over the period between 1st May 2021 and 30th April 2022 according to Italian legislation dlg 2192006 art125
Outcomes
The primary outcome is the time to acalabrutinib discontinuation defined as time in days from start date of acalabrutinib treatment to end date of acalabrutinib treatment
Secondary outcomes include Time from diagnosis to start of acalabrutinib immunophenotype CLL clinical stage Binet FISH profile mutations karyotype CLL treatments before acalabrutinib socio-demographic characteristics at baseline medical history concomitant treatments COVID-19 prophylaxis and treatments constitutional symptoms patient clinical status ECGTTE complete blood count with differential serum chemistry HIV and Hepatitis serology active haemolysis time to acalabrutinib discontinuation acalabrutinib treatment dosage relative changes temporary interruptionpermanent discontinuation
Exploratory outcomes include Time to progression Time to death CLL status according to iwCLL Time to Next Treatment Time to progression on next line treatment reasons for ending of CLL treatments following acalabrutinib discontinuation visits and hospitalizations due to CLL or suspected ADR during acalabrutinib treatment
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