Cardiotoxicities in Patients Receiving BTKi

Dana-Farber Cancer Institute

Overview

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.

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 Type

OBSERVATIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

ElectrocardiogramDIAGNOSTIC_TEST

ECG to monitor electrical activities of the heart on each visit

EchocardiogramDIAGNOSTIC_TEST

Echocardiogram at baseline and 6 months

Cardiac magnetic resonance imagingDIAGNOSTIC_TEST

Cardiac MRI at baseline and 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Patients with confirmed diagnosis of CLL who are planned to start either ibrutinib or acalabrutinib per standard of care, in monotherapy or in combination with an anti-CD20 antibody, venetoclax, and/or a PI3K inhibitor. Both treatment-naïve and relapsed or refractory CLL are allowed. * No known history of paroxysmal, persistent, or permanent atrial fibrillation. Exception: The study allows enrollment of up to 10 patients with a known history of paroxysmal atrial fibrillation (exploratory cohort). * No known history chronic symptomatic congestive heart failure or documented ejection fraction \< 50%. * Creatinine ≤ 1.5x institutional upper limit of normal (ULN). An adequate kidney function is necessary to ensure safety of IV contrast given before cardiac MRI. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%). Exclusion criteria * Prior exposure to ibrutinib or acalabrutinib. * Patients with a clinical contraindication to MRI. * Patients with childbearing potential who cannot or do not wish to use an effective method of contraception, during the study period and for 12 months after the final treatment used for the purposes of the study. * Patients with any medical condition, psychiatric condition, or social situation that in the opinion of the investigator would compromise compliance with study requirements.

Outcomes

Primary Outcomes

Incidence of atrial arrhythmias

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.

Time frame: During 6 months of BTK inhibitor therapy

Secondary Outcomes

Incidence of ventricular arrhythmias

Assessed by 28-day mobile telemetry

Time frame: During 6 months of BTK inhibitor therapy

Severity of ventricular arrythmia

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame: During 6 months of BTK inhibitor therapy

Data from ClinicalTrials.gov

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