Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205498
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-07-06
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:
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:
ARISE
Brief Summary:
Chronic lymphocytic leukemia CLL is the most common form of leukemia in the adults in the Western world with an annual incidence of approximately 5 cases per 100000 inhabitants in Italy
Acalabrutinib CalquenceTM a selective second-generation Bruton Tyrosine Kinase BTK inhibitor developed by AstraZeneca has been assessed for the treatment of CLL in three phase III clinical trials ELEVATE-TN treatment-naïve CLL ASCEND and ELEVATE RR relapsed and refractory CLL These pivotal randomized clinical trials established the efficacy and safety of acalabrutinib in patients with CLL and based on these data CalquenceTM received EMA approval in November 2020 for the treatment of CLL in adult patients and received AIFA Agenzia Italiana del Farmaco reimbursement as monotherapy in December 2021 However further data are still required to evaluate the use of acalabrutinib in the real-life conditions of post-marketing authorization
The primary aim of ARISE study is to evaluate the time to treatment discontinuation and reasons for discontinuation for acalabrutinib in a real world setting of patients with CLL This study will provide the first real-world data on the use of acalabrutinib in the treatment of CLL in Italy
Acalabrutinib CalquenceTM a selective second-generation Bruton Tyrosine Kinase BTK inhibitor developed by AstraZeneca has been assessed for the treatment of CLL in three phase III clinical trials ELEVATE-TN treatment-naïve CLL ASCEND and ELEVATE RR relapsed and refractory CLL These pivotal randomized clinical trials established the efficacy and safety of acalabrutinib in patients with CLL and based on these data CalquenceTM received EMA approval in November 2020 for the treatment of CLL in adult patients and received AIFA Agenzia Italiana del Farmaco reimbursement as monotherapy in December 2021 However further data are still required to evaluate the use of acalabrutinib in the real-life conditions of post-marketing authorization
The primary aim of ARISE study is to evaluate the time to treatment discontinuation and reasons for discontinuation for acalabrutinib in a real world setting of patients with CLL This study will provide the first real-world data on the use of acalabrutinib in the treatment of CLL in Italy
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