Examining blood cell growth patterns and heart health in Hodgkin lymphoma survivors
Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | Children's Oncology Group Research network |
| Drugs / interventions | chemotherapy, doxorubicin, radiation |
| Locations | 32 sites (Mobile, Alabama and 31 other locations) |
| Trial ID | NCT05705531 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mobile, Alabama and 31 other locations
- 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)
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (Recruiting)
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States (Recruiting)
- Arnold Palmer Hospital for Children — Orlando, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.