A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma

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

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-18

Study Completion Date

2028-10-01

Brief Summary

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This study assesses how blood cell growth patterns (clonal hematopoiesis), relates to heart health or cardiovascular disease (CVD) after treatment in patients with Hodgkin lymphoma. In some patients, cancer treatment at a young age may lead to later complications, including problems with heart health. Checking for blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) can help predict who might be at risk for heart health problems after Hodgkin lymphoma treatment. If doctors know who may be at greater risk for developing later heart complications, then they can more closely monitor those patients to prevent or detect heart complications early.

Detailed Description

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PRIMARY OBJECTIVES:

I. To assess the prevalence of participants in AHOD1331 with therapy-related clonal hematopoiesis (t-CH) possessing somatic mutations associated with cardiovascular disease (CVD) which are detected after Hodgkin Lymphoma therapy.

II. To assess participants of AHOD1331 with t-CH for the presence or absence of objective signs of CVD using cardiac magnetic resonance imaging (MRI).

SECONDARY OBJECTIVES:

I. To assess whether participants in AHOD1331 with t-CH expand this population over time and possess objective findings of CVD.

II. To assess whether patients both with and without objective findings of CVD using cardiac MRI possess clinical risk factors for CVD.

EXPLORATORY OBJECTIVES:

I. To assess the prevalence of patients receiving mediastinal radiation who have objective findings of CVD using cardiac MRI, that also possess t-CH with mutations associated with CVD.

II. To assess whether specific patient characteristics and treatment (age, sex, race, dexrazoxane usage, etc.) correlate with a higher incidence of t-CH with mutations associated with CVD.

III. To assess the effects of t-CH on CVD by considering other factors such as patient characteristics and clinical conditions associated with an elevated risk for CVD.

OUTLINE: This is an observational study.

Patients undergo collection of blood samples, complete surveys, and undergo cardiac MRI on study. Patients also have their medical records reviewed.

Conditions

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Cardiovascular Disorder Clonal Hematopoiesis Hodgkin Lymphoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Observational (blood samples, surveys, MRI, record review)

Patients undergo collection of blood samples, complete surveys, and undergo cardiac MRI on study. Patients also have their medical records reviewed.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood specimen collection

Electronic Health Record Review

Intervention Type OTHER

Undergo medical record abstraction

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Biospecimen Collection

Undergo blood specimen collection

Intervention Type PROCEDURE

Electronic Health Record Review

Undergo medical record abstraction

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI

Eligibility Criteria

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Inclusion Criteria

* Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).
* Enrolled and completed therapy on AHOD1331.
* Not known to have had a primary event (relapse/second malignancy/death). Note: Subjects enrolled and/or treated on AHOD1331 at another institution are eligible if they are now being followed at the current Children's Oncology Group (COG) institution.
* Patient must have access to cardiac MRI at institution where receiving follow-up care and must be able to complete cardiac MRI without sedation.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

* Medical contraindication to undergoing a cardiac MRI.
* Removed from AHOD1331 therapy prior to completing the AHOD1331 protocol specified treatment plan.
* Received cancer therapy in addition to that of AHOD1331 (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).
* History of cardiovascular disease prior to enrollment on AHOD1331.

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert J Hayashi

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

PMID: 37505794 (View on PubMed)