AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study.
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Study Overview: The Acalabrutinib Real World Italian obSErvational Study (ARISE) aims to evaluate the time to treatment discontinuation and reasons for discontinuation of acalabrutinib in patients with chronic lymphocytic leukemia (CLL) in Italy. This study is significant as it provides the first real-world data on acalabrutinib’s use in Italy, following its EMA approval and AIFA reimbursement.
Intervention/Treatment: The study focuses on acalabrutinib, a selective second-generation Bruton Tyrosine Kinase (BTK) inhibitor, used for treating CLL. It aims to assess its effectiveness and safety in real-world settings.
Study Design: ARISE is an observational, multicenter, longitudinal study using a retrospective cohort of CLL patients who began acalabrutinib treatment between May 2021 and April 2022. The study will follow patients for up to five years, collecting data from medical records.
Study Timeline: The study started on August 8, 2023, with its primary completion and estimated completion dates not specified. The last update was submitted on August 21, 2025, indicating ongoing data collection and analysis.
Market Implications: This study could influence AstraZeneca’s stock performance by providing insights into acalabrutinib’s real-world efficacy and safety, potentially affecting investor sentiment. Competitors in the CLL treatment market may also be impacted as real-world data becomes available.
The ARISE study is ongoing, with further details accessible on the ClinicalTrials portal.