NCT05521178

Brief 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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
20mo left

Started May 2024

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
May 2024Jan 2028

First Submitted

Initial submission to the registry

August 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

August 28, 2022

Last Update Submit

October 11, 2024

Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Keywords

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of ventricular arrhythmias

    During 6 months of BTK inhibitor therapy

  • Severity of ventricular arrythmia

    During 6 months of BTK inhibitor therapy

Study Arms (2)

Ibrutinib

Patients receiving ibrutinib for the treatment of CLL.

Diagnostic Test: ElectrocardiogramDiagnostic Test: EchocardiogramDiagnostic Test: Cardiac magnetic resonance imagingDevice: Mobile cardiac telemetryDiagnostic Test: Blood pressure monitoringDiagnostic Test: Blood draw

Acalabrutinib

Patients receiving acalabrutinib for the treatment of CLL.

Diagnostic Test: ElectrocardiogramDiagnostic Test: EchocardiogramDiagnostic Test: Cardiac magnetic resonance imagingDevice: Mobile cardiac telemetryDiagnostic Test: Blood pressure monitoringDiagnostic Test: Blood draw

Interventions

ElectrocardiogramDIAGNOSTIC_TEST

ECG to monitor electrical activities of the heart on each visit

Also known as: ECG
AcalabrutinibIbrutinib
EchocardiogramDIAGNOSTIC_TEST

Echocardiogram at baseline and 6 months

Also known as: TTE
AcalabrutinibIbrutinib
Cardiac magnetic resonance imagingDIAGNOSTIC_TEST

Cardiac MRI at baseline and 6 months

Also known as: Cardiac MRI
AcalabrutinibIbrutinib
Mobile cardiac telemetryDEVICE

Mobile cardiac telemetry at baseline and 6 months

Also known as: Mobile telemetry
AcalabrutinibIbrutinib
Blood pressure monitoringDIAGNOSTIC_TEST

Home blood pressure monitoring three times per week

Also known as: Home blood pressure monitoring
AcalabrutinibIbrutinib
Blood drawDIAGNOSTIC_TEST

Blood draw at baseline, 3 and 6 months

AcalabrutinibIbrutinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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%).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples With DNA: Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood)

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ElectrocardiographyEchocardiographyBlood Pressure Monitoring, AmbulatoryBlood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyBlood Pressure DeterminationMonitoring, AmbulatoryMonitoring, PhysiologicSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Inhye Ahn, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2022

First Posted

August 30, 2022

Study Start

May 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu