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NCT04938141 Clinical Trial

MEOI and HRQoL in CLL Patients Treated With BTKis

Chronic Lymphocytic Leukemia Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04938141
Other study ID # D8220R00036
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 7, 2021
Est. completion date September 5, 2024

Study information
Verified date April 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 23
Est. completion date September 5, 2024
Est. primary completion date September 5, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Research Site Amherst New York
United States Research Site Berkeley Heights New Jersey
United States Research Site Boca Raton Florida
United States Research Site Charlotte North Carolina
United States Research Site Fort Lauderdale Florida
United States Research Site Fountain Valley California
United States Research Site Honolulu Hawaii
United States Research Site Jackson Mississippi
United States Research Site Philadelphia Pennsylvania
United States Research Site Redlands California
United States Research Site Saint Petersburg Florida
United States Research Site Savannah Georgia
United States Research Site Tallahassee Florida
United States Research Site Tamarac Florida
United States Research Site Tampa Florida
United States Research Site York Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Characteristics To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib. Baseline
Primary 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 24 Month Follow-up
Primary 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. 24 month follow-up
Primary HRQoL To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period 24 month follow-up
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