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

Last updated: May 1, 2026
Sponsor: Children's Oncology Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

White Cell Disorders

Hematologic Cancer

Treatment

Magnetic Resonance Imaging

Electronic Health Record Review

Survey Administration

Clinical Study ID

NCT05705531
ALTE21C1
COG-ALTE21C1
ALTE21C1
NCI-2022-09972
UG1CA189955
  • Ages > 7
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patient must be >= 7 years of age at the time of enrollment (age to perform an MRIwithout sedation).

  • History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initiallydiagnosed when the patient was >= 2 and < 22 years of age.

  • As part of frontline therapy for cHL, the patient must have received a cumulativedoxorubicin equivalent anthracycline dose of ≥ 200 mg/m^2 as estimated indoxorubicin isotoxic equivalents dose conversion calculation.

  • Note: History of COG therapeutic trial participation is not required.Institutional records (e.g., clinic note, treatment summary, chemotherapyroadmap) can be used as reference documentation of receipt of anthracyclinedose.

  • All systemic cancer treatment must have been completed ≥ 2 years prior to studyenrollment.

  • Not known to have had a primary event (relapse/second malignancy/death).

  • Note: Subjects treated at another institution are eligible if they are nowbeing followed at the current COG institution, if the study procedures can beperformed 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 beable to complete cardiac MRI without sedation.

Exclusion

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., fordisease progression or recurrence, or subsequent malignant neoplasm).

  • History of CTCAE grade 3 or higher cardiovascular disease or condition known toexist prior to the patient's initial diagnosis of cHL.

  • Note: exceptions are made for congenital conditions considered fully resolvedby surgery and chronic conditions such as hypertension or hypercholesterolemiathat are managed with medical intervention.

  • History of an immunodeficiency that existed prior to cHL diagnosis, such as primaryimmunodeficiency syndromes, organ transplant recipients and conditions requiringsystemic immunosuppressive agents.

Study Design

Total Participants: 190
Treatment Group(s): 5
Primary Treatment: Magnetic Resonance Imaging
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
October 01, 2028

Study 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.

Connect with a study center

  • Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Suspended

  • Hospital for Sick Children

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • USA Health Strada Patient Care Center

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • USA Health Strada Patient Care Center

    Mobile 4076598, Alabama 4829764 36604
    United States

    Site Not Available

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Phoenix Childrens Hospital

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Yale University

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Site Not Available

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware 19803
    United States

    Active - Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Site Not Available

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida 32806
    United States

    Active - Recruiting

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

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers 4155995, Florida 4155751 33908
    United States

    Site Not Available

  • Arnold Palmer Hospital for Children

    Orlando 4167147, Florida 4155751 32806
    United States

    Site Not Available

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

    Tampa 4174757, Florida 4155751 33607
    United States

    Site Not Available

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

  • C S Mott Children's Hospital

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • C S Mott Children's Hospital

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis 5037649, Minnesota 5037779 55404
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Albany Medical Center

    Albany 5106834, New York 5128638 12208
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus 4509177, Ohio 5165418 43205
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh 5206379, Pennsylvania 6254927 15224
    United States

    Site Not Available

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee 37916
    United States

    Active - Recruiting

  • East Tennessee Childrens Hospital

    Knoxville 4634946, Tennessee 4662168 37916
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Children's Hospital of San Antonio

    San Antonio, Texas 78207
    United States

    Active - Recruiting

  • Cook Children's Medical Center

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Children's Hospital of San Antonio

    San Antonio 4726206, Texas 4736286 78207
    United States

    Site Not Available

  • University of Virginia Cancer Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • University of Virginia Cancer Center

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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