A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Dana-Farber Cancer Institute
- Primary Endpoint
- Incidence of atrial arrhythmias
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
This is a multicenter, prospective, observational cohort study to comprehensively and longitudinally evaluate and characterizes the cardiovascular events with CLL patients who are initiating treatment with a Bruton's tyrosine kinase (BTK) inhibitor ibrutinib or acalabrutinib.
Detailed Description
This research study includes three visits for research blood, physical exam, and cardiac testing at baseline, 3 months, and 6 months. The study will collect the following data during the 6-month study period: * Blood sample collection * Electrocardiogram (ECG) * Echocardiogram * Cardiac magnetic resonance imaging (MRI) * Mobile cardiac telemetry * Blood pressure measurement
Investigators
Inhye Ahn
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of atrial arrhythmias
Time Frame: During 6 months of BTK inhibitor therapy
Any documented evidence of atrial arrhythmia including symptomatic and asymptomatic events captured by EKG, 28-day mini cardiac telemetry, or monitoring of cardiac rhythm during echocardiogram or cardiac MRI.
Secondary Outcomes
- Severity of ventricular arrythmia(During 6 months of BTK inhibitor therapy)
- Incidence of ventricular arrhythmias(During 6 months of BTK inhibitor therapy)