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NCT05705531Recruiting

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

Children's Oncology Group

Start Date

8/18/2023

Completion Date

10/1/2028

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.

Eligibility Criteria

Age Range: 7 years to No maximum

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.

Interventions

PROCEDURE

Archive Sample Retrieval

PROCEDURE

Biospecimen Collection

OTHER

Electronic Health Record Review

PROCEDURE

Magnetic Resonance Imaging

OTHER

Survey Administration

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Conditions

Cardiovascular DisorderClassic Hodgkin LymphomaClonal Hematopoiesis

Locations

USA Health Strada Patient Care Center

Mobile, Alabama 36604

United States

Phoenix Childrens Hospital

Phoenix, Arizona 85016

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

Valley Children's Hospital

Madera, California 93636

United States

Connecticut Children's Medical Center

Hartford, Connecticut 06106

United States

Yale University

New Haven, Connecticut 06520

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware 19803

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida 33908

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida 32207

United States

Arnold Palmer Hospital for Children

Orlando, Florida 32806

United States

Nemours Children's Hospital

Orlando, Florida 32827

United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida 32504

United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida 33607

United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia 30329

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland 21201

United States

C S Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota 55404

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Albany Medical Center

Albany, New York 12208

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania 15224

United States

East Tennessee Childrens Hospital

Knoxville, Tennessee 37916

United States

Cook Children's Medical Center

Fort Worth, Texas 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas 78207

United States

University of Virginia Cancer Center

Charlottesville, Virginia 22908

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States

Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada