Cardiotoxicities in Patients Receiving BTKi

Withdrawn

• Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia
• Interventions: Diagnostic Test: Electrocardiogram; Diagnostic Test: Echocardiogram; Diagnostic Test: Cardiac magnetic resonance imaging; Device: Mobile cardiac telemetry; Diagnostic Test: Blood pressure monitoring; Diagnostic Test: Blood draw

• 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

Study Timeline

• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-08-28
• Study First Posted: 2022-08-30
• Study Start: 2024-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ibrutinib	Echocardiogram	Patients receiving ibrutinib for the treatment of CLL.
Acalabrutinib	Blood draw	Patients receiving acalabrutinib for the treatment of CLL.
Acalabrutinib	Electrocardiogram	Patients receiving acalabrutinib for the treatment of CLL.
Acalabrutinib	Echocardiogram	Patients receiving acalabrutinib for the treatment of CLL.
Ibrutinib	Cardiac magnetic resonance imaging	Patients receiving ibrutinib for the treatment of CLL.
Ibrutinib	Mobile cardiac telemetry	Patients receiving ibrutinib for the treatment of CLL.
Ibrutinib	Electrocardiogram	Patients receiving ibrutinib for the treatment of CLL.
Ibrutinib	Blood pressure monitoring	Patients receiving ibrutinib for the treatment of CLL.
Ibrutinib	Blood draw	Patients receiving ibrutinib for the treatment of CLL.
Acalabrutinib	Cardiac magnetic resonance imaging	Patients receiving acalabrutinib for the treatment of CLL.
Acalabrutinib	Mobile cardiac telemetry	Patients receiving acalabrutinib for the treatment of CLL.
Acalabrutinib	Blood pressure monitoring	Patients receiving acalabrutinib for the treatment of CLL.

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