NCT05645172

Retention Rate of Acalabrutinib in a Non-interventional Setting

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 137 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Retention rate of acalabrutinib in a non-interventional setting. This is a prospective, multicentre, non-interventional study to collect real-world data on retention rates of CLL patients prescribed with acalabrutinib in Germany.

Detailed description

This observational study will prospectively assess acalabrutinib therapy retention of CLL patients one year and 2 years after treatment initiation with acalabrutinib in routine clinical practice. Furthermore, therapy adherence, treatment efficacy, overall survival, and QoL to analyse the possible influence of psychological aspects of the patient-based disease perception, a four-group-segmentation for acceptance and perceived control of the health state will be conducted. Finally, disease-, treatment-, and patient-specific factors possibly affecting therapy retention will be analysed: sociodemographic factors, disease and treatment characteristics, comorbidities, therapy adherence, treatment effectiveness, safety, QoL, and psychological segmentation.

Conditions

• Chronic Lymphocytic Leukaemia (CLL)

Timeline

• Start date: 2022-12-12
• Primary completion: 2026-10-15
• Completion: 2026-10-15
• First posted: 2022-12-09
• Last updated: 2025-12-01

Locations

61 sites across 1 country: Germany