MEOI and HRQoL in CLL Patients Treated With BTKis

Completed

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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)

Key facts

Study ID

NCT04938141

Run by

AstraZeneca

People needed

23

Starts

2021-10-07

Expected to finish

2024-09-26

Last updated by the study team

2025-05-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

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

Where it is running

• Research Site — Fountain Valley, California, United States
• Research Site — Redlands, California, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Tallahassee, Florida, United States
• Research Site — Tamarac, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Honolulu, Hawaii, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — Berkeley Heights, New Jersey, United States
• Research Site — Amherst, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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