National Acalabrutinib Observational Study - Trial NCT05437250

Timeline & Enrollment

Primary Outcome

Time to Discontinuation

Summary

The efficacy and safety of acalabrutinib in the treatment of patients with chronic
 lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials
 (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November
 2020. The aim of this French longitudinal, non-interventional/observational, multicenter
 study is to describe the efficacy and safety of acalabrutinib treatment for CLL patients in
 real life.
 
 The primary objective is then to estimate the time to discontinuation of acalabrutinib
 therapy and the reasons for discontinuation, overall and by treatment line.
 
 The secondary objectives are to describe the baseline clinical and demographic
 characteristics of patients with CLL treated with acalabrutinib, to assess the efficacy of
 acalabrutinib through progression-free survival, overall survival, time to next treatment or
 death, describe acalabrutinib treatment patterns in CLL patients and reasons, identify key
 determinants of acalabrutinib discontinuation in CLL patients, estimate healthcare resource
 utilization. The overall response rate will be estimated as an exploratory objective.
 
 Patients included in this study will be CLL patients treated with acalabrutinib at the
 discretion of their physician between January 1, 2021 and December 31, 2022, who have been
 informed of the study and do not object to electronic processing of their data for research
 purposes (or do not object during their lifetime in the event of the patient's death prior to
 study initiation).
 
 Secondary data will be extracted from the hospital's patient records once a year. The
 protocol calls for the recruitment of 350 patients at 70 centres with a 3-year follow-up.
 Interim analyses will be performed annually until the end of the study.

ICD-10 Classifications