MEOI and HRQoL in CLL Patients Treated With BTKis

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT04938141
• Lead Sponsor: AstraZeneca

Brief Summary

This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton's tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-24
• Study Start: 2021-10-07
• Primary Completion: 2024-09-26
• Study Completion: 2024-09-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• ≥18 years old
• Physician-confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL)
• BTKi naïve patients who initiate acalabrutinib or ibrutinib treatment alone or in combination with an anti-CD20 mAb within 7 days (before or after) study enrollment*. Both treatment naïve and relapsed/refractory CLL patients will be included.
• Provides informed consent
• Adequate English reading skills
• Able to access and use a computer, tablet, or smartphone to complete PROs

Exclusion Criteria

• Use of BTKi any time prior to study enrollment.
• Currently receiving systemic treatment for another malignancy
• Currently enrolled in a clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chart Recorded Medical Events of Interest	24 Month Follow-up	To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period
Patient Characteristics	Baseline	To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
HRQoL	24 month follow-up	To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period
Patient Reported Medical Events of Interest	24 month follow-up	To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period.

Trial Locations

Locations (1)

Research Site; 🇺🇸 York, Pennsylvania, United States