Acalabrutinib Real World Italian obSErvational Study -ARISE - Trial NCT06205498

Timeline & Enrollment

Primary Outcome

time to acalabrutinib discontinuation

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.
 
 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 R/R (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.

ICD-10 Classifications