RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-18
Study Completion:2028-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05705531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).
  2. * History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \>= 2 and \< 22 years of age.
  3. * 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.
  4. * 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.
  5. * All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment.
  6. * Not known to have had a primary event (relapse/second malignancy/death).
  7. * 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.
  8. * Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation.
  1. * Medical contraindication to undergoing a non-contrast cardiac MRI.
  2. * Patients with nodular lymphocyte-predominant HL.
  3. * Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).
  4. * History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL.
  5. * 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.
  6. * History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents.

Contacts and Locations

Principal Investigator

Robert J Hayashi
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

USA Health Strada Patient Care Center
Mobile, Alabama, 36604
United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
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
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
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
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

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Robert J Hayashi, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-18
Study Completion Date2028-10-01

Study Record Updates

Study Start Date2023-08-18
Study Completion Date2028-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiovascular Disorder
  • Classic Hodgkin Lymphoma
  • Clonal Hematopoiesis