NCT05705531

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

Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 190 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

This study assesses how blood cell growth patterns (clonal hematopoiesis) relate 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

PRIMARY OBJECTIVES: I. To assess the prevalence of therapy-related clonal hematopoiesis (t-CH) possessing somatic mutations associated with cardiovascular disease (CVD) in anthracycline exposed pediatric classical Hodgkin Lymphoma patients detected after front line Hodgkin Lymphoma therapy. II. To compare rates of t-CH possessing somatic mutations associated with CVD between anthracycline exposed pediatric classical Hodgkin Lymphoma patients with versus without objective signs of CVD according to cardiac magnetic resonance imaging (MRI). SECONDARY OBJECTIVES: I. To evaluate whether the incidence of t-CH possessing somatic mutations associated with CVD increases over time among pediatric classical Hodgkin Lymphoma patients previously treated with anthracyclines. II. To compare rates of objective findings of CVD between groups of anthracycline exposed pediatric classical Hodgkin Lymphoma patients with versus without clinical risk factors for CVD. EXPLORATORY OBJECTIVES: I. To compare the prevalence of t-CH with mutations associated with CVD between anthracycline exposed pediatric classical Hodgkin Lymphoma patients who received versus did not receive mediastinal radiation as part of their initial treatment. II. To assess whether specific patient characteristics and other treatment components (age, sex, race, dexrazoxane usage, etc.) are associated with an increased likelihood of t-CH with mutations associated with CVD. III. To evaluate the effect of t-CH with mutations associated with CVD on objective findings of CVD, as adjusted for or mediated by 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 and may have archived blood samples collected if available.

Conditions

• Cardiovascular Disorder
• Classic Hodgkin Lymphoma
• Clonal Hematopoiesis

Interventions

Type	Name	Description
PROCEDURE	Archive Sample Retrieval	Undergo collection of archived blood sample
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Electronic Health Record Review	Undergo medical record abstraction
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Survey Administration	Complete surveys

Timeline

• Start date: 2023-08-18
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2023-01-30
• Last updated: 2026-02-24

Locations

29 sites across 2 countries: United States, Canada