National Acalabrutinib Observational Study

Launched by ASTRAZENECA · Jun 27, 2022

Keywords

ClinConnect Summary

The National Acalabrutinib Observational Study is looking at how well the drug acalabrutinib works in treating people with chronic lymphocytic leukemia (CLL) in real-life settings. While earlier clinical trials have shown that acalabrutinib is effective and safe, this study aims to gather more information on how patients respond to the treatment outside of a controlled trial environment. Researchers will track how long patients stay on the medication, the reasons for stopping, and overall health outcomes over three years.

To be eligible for this study, participants must be adults aged 18 or older who started treatment with acalabrutinib between January 1, 2021, and December 31, 2022. They should be alive when the study begins and must give permission for their health data to be used for research. This study will include around 350 patients across 70 different centers, and the information collected will help doctors understand the real-world effects of acalabrutinib for people living with CLL. Participants can expect to have their health records reviewed annually to help track their progress.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients aged ≥ 18 years old,
• • CLL patients initiated with acalabrutinib at their physician's discretion between January 1st 2021 and December 31st 2022,
• • Patients alive at study initiation and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician); or patient who died before study initiation and who did not object to data collection for research purpose(s) during his or her lifetime.
• Exclusion Criteria:
• • Patients participating in a clinical trial with an investigational drug within 30 days prior to acalabrutinib initiation,
• • Patients who initiated acalabrutinib treatment before January 1st 2021.