Cardiotoxicities in Patients Receiving BTKi

NCT ID: NCT05521178

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2028-01-01

Brief Summary

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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

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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

Conditions

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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ibrutinib

Patients receiving ibrutinib for the treatment of CLL.

Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

ECG to monitor electrical activities of the heart on each visit

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

Echocardiogram at baseline and 6 months

Cardiac magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Cardiac MRI at baseline and 6 months

Mobile cardiac telemetry

Intervention Type DEVICE

Mobile cardiac telemetry at baseline and 6 months

Blood pressure monitoring

Intervention Type DIAGNOSTIC_TEST

Home blood pressure monitoring three times per week

Blood draw

Intervention Type DIAGNOSTIC_TEST

Blood draw at baseline, 3 and 6 months

Acalabrutinib

Patients receiving acalabrutinib for the treatment of CLL.

Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

ECG to monitor electrical activities of the heart on each visit

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

Echocardiogram at baseline and 6 months

Cardiac magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Cardiac MRI at baseline and 6 months

Mobile cardiac telemetry

Intervention Type DEVICE

Mobile cardiac telemetry at baseline and 6 months

Blood pressure monitoring

Intervention Type DIAGNOSTIC_TEST

Home blood pressure monitoring three times per week

Blood draw

Intervention Type DIAGNOSTIC_TEST

Blood draw at baseline, 3 and 6 months

Interventions

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Electrocardiogram

ECG to monitor electrical activities of the heart on each visit

Intervention Type DIAGNOSTIC_TEST

Echocardiogram

Echocardiogram at baseline and 6 months

Intervention Type DIAGNOSTIC_TEST

Cardiac magnetic resonance imaging

Cardiac MRI at baseline and 6 months

Intervention Type DIAGNOSTIC_TEST

Mobile cardiac telemetry

Mobile cardiac telemetry at baseline and 6 months

Intervention Type DEVICE

Blood pressure monitoring

Home blood pressure monitoring three times per week

Intervention Type DIAGNOSTIC_TEST

Blood draw

Blood draw at baseline, 3 and 6 months

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ECG TTE Cardiac MRI Mobile telemetry Home blood pressure monitoring

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Inhye Ahn

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inhye Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Other Identifiers

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22-301

Identifier Type: -

Identifier Source: org_study_id

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