Cardiotoxicities in Patients Receiving BTKi

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Multicenter, Prospective Cohort Study for Detection of Cardiotoxicities in Patients Receiving Ibrutinib or Acalabrutinib for CLL

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05521178
• Other study ID #: 22-301
• Status: Withdrawn
• Start date: May 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: May 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiotoxicity
• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Lymphoma

Intervention

Diagnostic Test:
• Electrocardiogram
ECG to monitor electrical activities of the heart on each visit
• Echocardiogram
Echocardiogram at baseline and 6 months
• Cardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months

Device:
• Mobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months

Diagnostic Test:
• Blood pressure monitoring
Home blood pressure monitoring three times per week
• Blood draw
Blood draw at baseline, 3 and 6 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During 6 months of BTK inhibitor therapy
Secondary	Incidence of ventricular arrhythmias	Assessed by 28-day mobile telemetry	During 6 months of BTK inhibitor therapy
Secondary	Severity of ventricular arrythmia	NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	During 6 months of BTK inhibitor therapy