Cardiotoxicities in Patients Receiving BTKi
- Conditions
- Small Lymphocytic LymphomaChronic Lymphocytic Leukemia
- Registration Number
- NCT05521178
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of atrial arrhythmias 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 Outcome Measures
Name Time Method Severity of ventricular arrythmia During 6 months of BTK inhibitor therapy NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of ventricular arrhythmias During 6 months of BTK inhibitor therapy Assessed by 28-day mobile telemetry
Related Research Topics
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