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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

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