Status:
COMPLETED
Acalabrutinib Real World Italian obSErvational Study -ARISE
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Yghea
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
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 100,000 inhabitants in Italy. Acalabru...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria All consecutive patients with CLL who received acalabrutinib according to Italian legislation dlg 219/2006 art.125 will be eligible for inclusion in the study, subject to site agreement and patient consent to participate.
- Patients must meet the following criteria for study entry:
- Age ≥ 18 years old at the date of consent subscription.
- Diagnosis of CLL.
- Treatment of CLL with acalabrutinib at physician's discretion initiated between 1st May 2021 and 30th April 2022.
- Informed consent to participate in the study and privacy form signed by the patient (or their legal representative).
- Exclusion Criteria
- Patients who meet any of the following criteria will be excluded:
- 1\. Acalabrutinib treatment initiation before 1st May 2021 or after 30th April 2022.
Exclusion
Key Trial Info
Start Date :
August 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 8 2025
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT06205498
Start Date
August 8 2023
End Date
January 8 2025
Last Update
August 22 2025
Active Locations (41)
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1
Research Site
Alessandria, Italy, 15121
2
Research Site
Ancona, Italy, 60126
3
Research Site
Bari, Italy, 70124
4
Research Site
Barletta, Italy, 76121