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

RECRUITINGSponsored by Children's Oncology Group
Actively Recruiting
SponsorChildren's Oncology Group
Started2023-08-18
Est. completion2028-10-01
Eligibility
Age7 Years+
Healthy vol.Accepted
Locations28 sites

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.

Eligibility

Age: 7 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions4

Cardiovascular DisorderClassic Hodgkin LymphomaClonal HematopoiesisHeart Disease

Locations28 sites

USA Health Strada Patient Care Center
Mobile, Alabama, 36604
Site Public Contact800-388-8721
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Site Public Contact602-546-0920
Yale University
New Haven, Connecticut, 06520
Site Public Contact203-785-5702canceranswers@yale.edu
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Site Public Contact302-651-5572Allison.bruce@nemours.org
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Site Public Contact239-343-5333molly.arnstrom@leehealth.org

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