MEOI and HRQoL in CLL Patients Treated With BTKis

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)

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Fountain Valley, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Patient Characteristics

Time frame: Baseline

To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.
Chart Recorded Medical Events of Interest

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jun 24, 2021
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed