MEOI and HRQoL in CLL Patients Treated With BTKis

AstraZeneca

Status: Completed

Conditions: Chronic Lymphocytic Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT04938141

D8220R00036

Details and patient eligibility

About

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)

Enrollment: 23 patients

Sex: All

Volunteers: No 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

Trial design

23 participants in 2 patient groups

Acalabrutinib

Description:

CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb

Ibrutinib

Description:

CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb