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

Recruiting now

Conditions studied: Cardiovascular Disorder, Classic Hodgkin Lymphoma, Clonal Hematopoiesis

In brief

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.

Key facts

Study ID

NCT05705531

Run by

Children's Oncology Group

People needed

190

Starts

2023-08-18

Expected to finish

2028-10-01

Last updated by the study team

2026-07-30

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be >= 7 years of age at the time of enrollment (age to perform an MRI without sedation).
• History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was >= 2 and < 22 years of age.
• As part of frontline therapy for cHL, the patient must have received a cumulative doxorubicin equivalent anthracycline dose of ≥ 200 mg/m\^2 as estimated in doxorubicin isotoxic equivalents dose conversion calculation.
• Note: History of COG therapeutic trial participation is not required. Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used as reference documentation of receipt of anthracycline dose.
• All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment.
• Not known to have had a primary event (relapse/second malignancy/death).
• Note: Subjects treated at another institution are eligible if they are now being followed at the current COG institution, if the study procedures can be performed and the data accessible by a COG institution where the study is open.
• Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation.

You may not qualify if…

• Medical contraindication to undergoing a non-contrast cardiac MRI.
• Patients with nodular lymphocyte-predominant HL.
• Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).
• History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL.
• Note: exceptions are made for congenital conditions considered fully resolved by surgery and chronic conditions such as hypertension or hypercholesterolemia that are managed with medical intervention.
• History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents.

Where it is running

• USA Health Strada Patient Care Center — Mobile, Alabama, United States (enrolling)
• Phoenix Childrens Hospital — Phoenix, Arizona, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Valley Children's Hospital — Madera, California, United States (enrolling)
• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States (enrolling)
• Arnold Palmer Hospital for Children — Orlando, Florida, United States (enrolling)
• Nemours Children's Hospital — Orlando, Florida, United States (enrolling)
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States (enrolling)
• Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States (enrolling)
• Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States (enrolling)
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States (enrolling)
• Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Albany Medical Center — Albany, New York, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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