MEOI and HRQoL in CLL Patients Treated With BTKis

Medical Events of Interest and Health-Related Quality of Life in Chronic Lymphocytic Leukemia Patients Initiating Treatment With Bruton's Tyrosine Kinase Inhibitors Acalabrutinib or Ibrutinib

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04938141

Enrollment

Registered

2021-06-24

Start date

2021-10-07

Completion date

2024-09-26

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Characteristics	Baseline	To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
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 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.
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

Countries

United States

Outcome results