Clinical trial Recruiting at 35 sites Observational Ages 7 and up

Examining blood cell growth patterns and heart health in Hodgkin lymphoma survivors

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

Run by Children's Oncology Group · NCT05705531 · Data updated 2026-11-12

This study is trying to see if certain blood cell changes in people who survived Hodgkin lymphoma can help us understand their heart health better and identify those at risk for heart problems.

More Classic Hodgkin Lymphoma trials

Quick facts

Study typeObservational
Ages7 Years and up
SexAll
Enrollment190 (estimated)
SponsorChildren's Oncology Group
Research network
Drugs / interventionschemotherapy, doxorubicin, radiation
Locations36 sites (Mobile, Alabama and 35 other locations)
StatusRecruiting
StartedAugust 18, 2023
Main results expectedOctober 1, 2028
Study endsOctober 1, 2028
Registry record updatedAugust 25, 2026
Trial IDNCT05705531 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients aged 7 years and older who have completed therapy for Hodgkin lymphoma and have access to cardiac MRI.

Probably not a fit

Patients with medical contraindications to undergoing a cardiac MRI or those who have not completed the specified treatment plan for Hodgkin lymphoma will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the relationship between blood cell growth patterns, known as therapy-related clonal hematopoiesis (t-CH), and cardiovascular health in patients who have undergone treatment for Hodgkin lymphoma. The study aims to identify the prevalence of somatic mutations associated with cardiovascular disease (CVD) in these patients and assess their heart health using cardiac magnetic resonance imaging (MRI). By understanding these patterns, the study seeks to identify individuals at higher risk for heart complications, allowing for closer monitoring and early intervention. Participants will provide blood samples, complete surveys, and undergo cardiac MRI, while their medical records will be reviewed for comprehensive analysis.

Why it matters

Potential benefit: If successful, this study could help identify Hodgkin lymphoma survivors at risk for heart complications, enabling early intervention and improved heart health outcomes.

How similar studies have gone: While this study explores a novel approach to understanding heart health in Hodgkin lymphoma survivors, similar studies have indicated the importance of monitoring cardiovascular health in cancer survivors.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • USA Health Strada Patient Care Center
    Mobile, Alabama, United States
    Recruiting
  • Phoenix Childrens Hospital
    Phoenix, Arizona, United States
    Recruiting
  • City of Hope Comprehensive Cancer Center
    Duarte, California, United States
    Recruiting
  • Valley Children's Hospital
    Madera, California, United States
    Recruiting
  • Connecticut Children's Medical Center
    Hartford, Connecticut, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
Show 30 more locations
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware, United States
    Recruiting
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida, United States
    Recruiting
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida, United States
    Recruiting
  • Arnold Palmer Hospital for Children
    Orlando, Florida, United States
    Recruiting
  • Nemours Children's Hospital
    Orlando, Florida, United States
    Recruiting
  • Nemours Children's Clinic - Pensacola
    Pensacola, Florida, United States
    Recruiting
  • Saint Joseph's Hospital/Children's Hospital-Tampa
    Tampa, Florida, United States
    Recruiting
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois, United States
    Recruiting
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland, United States
    Recruiting
  • C S Mott Children's Hospital
    Ann Arbor, Michigan, United States
    Recruiting
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
    Minneapolis, Minnesota, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Recruiting
  • Albany Medical Center
    Albany, New York, United States
    Recruiting
  • Roswell Park Cancer Institute
    Buffalo, New York, United States
    Recruiting
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio, United States
    Recruiting
  • Oregon Health and Science University
    Portland, Oregon, United States
    Recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • East Tennessee Childrens Hospital
    Knoxville, Tennessee, United States
    Recruiting
  • Cook Children's Medical Center
    Fort Worth, Texas, United States
    Recruiting
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    Houston, Texas, United States
    Recruiting
  • Children's Hospital of San Antonio
    San Antonio, Texas, United States
    Recruiting
  • University of Virginia Cancer Center
    Charlottesville, Virginia, United States
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington, United States
    Recruiting
  • University of Wisconsin Carbone Cancer Center - University Hospital
    Madison, Wisconsin, United States
    Recruiting
  • Hospital for Sick Children
    Toronto, Ontario, Canada
    Suspended

Study contacts

  • Principal investigator: Robert J Hayashi — Children's Oncology Group

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.