Cardiotoxicities in Patients Receiving BTKi

February 15, 2024 updated by: Inhye Ahn, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Inhye E. Ahn, MD
        • Contact:
          • Inhye E Ahn, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ibrutinib
Patients receiving ibrutinib for the treatment of CLL.
Diagnostic test: Electrocardiogram
ECG to monitor electrical activities of the heart on each visit
Other Names:
  • ECG
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 6 months
Other Names:
  • TTE
Diagnostic test: Cardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months
Other Names:
  • Cardiac MRI
Device: Mobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months
Other Names:
  • Mobile telemetry
Diagnostic test: Blood pressure monitoring
Home blood pressure monitoring three times per week
Other Names:
  • Home blood pressure monitoring
Diagnostic test: Blood draw
Blood draw at baseline, 3 and 6 months
Acalabrutinib
Patients receiving acalabrutinib for the treatment of CLL.
Diagnostic test: Electrocardiogram
ECG to monitor electrical activities of the heart on each visit
Other Names:
  • ECG
Diagnostic test: Echocardiogram
Echocardiogram at baseline and 6 months
Other Names:
  • TTE
Diagnostic test: Cardiac magnetic resonance imaging
Cardiac MRI at baseline and 6 months
Other Names:
  • Cardiac MRI
Device: Mobile cardiac telemetry
Mobile cardiac telemetry at baseline and 6 months
Other Names:
  • Mobile telemetry
Diagnostic test: Blood pressure monitoring
Home blood pressure monitoring three times per week
Other Names:
  • Home blood pressure monitoring
Diagnostic test: Blood draw
Blood draw at baseline, 3 and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of atrial arrhythmias
Time Frame: 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.
During 6 months of BTK inhibitor therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ventricular arrhythmias
Time Frame: During 6 months of BTK inhibitor therapy
Assessed by 28-day mobile telemetry
During 6 months of BTK inhibitor therapy
Severity of ventricular arrythmia
Time Frame: During 6 months of BTK inhibitor therapy
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
During 6 months of BTK inhibitor therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Inhye Ahn, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 28, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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