MEOI and HRQoL in CLL Patients Treated With BTKis

AstraZeneca23 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Lymphocytic Leukemia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (16)

Research Site

Fountain Valley, California, United States

Research Site

Redlands, California, United States

Research Site

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

Patient Characteristics

To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib.

Time frame: Baseline

Chart Recorded Medical Events of Interest

To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period

Time frame: 24 Month Follow-up

Patient Reported Medical Events of Interest

To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period.

Time frame: 24 month follow-up

HRQoL

To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period

Time frame: 24 month follow-up

Data from ClinicalTrials.gov

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