Cardiotoxicities in Patients Receiving BTKi

Dana-Farber Cancer Institute

Status: Withdrawn

Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Diagnostic Test: Echocardiogram; Diagnostic Test: Electrocardiogram; Diagnostic Test: Blood pressure monitoring; Diagnostic Test: Blood draw; Device: Mobile cardiac telemetry; Diagnostic Test: Cardiac magnetic resonance imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05521178

22-301

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

0 participants in 2 patient groups

Ibrutinib

Description:

Patients receiving ibrutinib for the treatment of CLL.

Treatment:

Diagnostic Test: Cardiac magnetic resonance imaging

Diagnostic Test: Blood draw

Device: Mobile cardiac telemetry

Diagnostic Test: Blood pressure monitoring

Diagnostic Test: Electrocardiogram

Diagnostic Test: Echocardiogram

Acalabrutinib

Description:

Patients receiving acalabrutinib for the treatment of CLL.

Treatment:

Diagnostic Test: Cardiac magnetic resonance imaging

Diagnostic Test: Blood draw

Device: Mobile cardiac telemetry

Diagnostic Test: Blood pressure monitoring

Diagnostic Test: Electrocardiogram

Diagnostic Test: Echocardiogram