A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors
4 other identifiers
observational
190
2 countries
32
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
May 5, 2026
February 1, 2026
5.1 years
January 11, 2023
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Therapy-related clonal hematopoiesis (t-CH) with mutations associated with cardiovascular disease
Measured in the blood of eligible participants who were previously treated with anthracycline-containing therapy for pediatric classical Hodgkin lymphoma.
Up to 1 year
Secondary Outcomes (2)
Expansion of CH
Up to 1 year
Association between the presence of CVD and individual variables
Up to 1 year
Other Outcomes (3)
Prevalence and nature of CVD, CH and CH with mutations associated with cardiovascular disease
Up to 1 year
Patient characteristics and treatments
Up to 1 year
Effect of therapy-related clonal hematopoiesis on cardiovascular disease
Up to 1 year
Study Arms (1)
Observational (blood samples, surveys, MRI, record review)
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.
Interventions
Undergo collection of archived blood sample
Undergo blood sample collection
Undergo medical record abstraction
Undergo MRI
Complete surveys
Eligibility Criteria
Patients with pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \>= 2 and \< 22 years of age
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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
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
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
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
Related Publications (1)
Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
PMID: 37505794DERIVED
Biospecimen
Blood
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Hayashi
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 30, 2023
Study Start
August 18, 2023
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-02