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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Years and up |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Children's Oncology Group Research network |
| Drugs / interventions | chemotherapy, doxorubicin, radiation |
| Locations | 36 sites (Mobile, Alabama and 35 other locations) |
| Status | Recruiting |
| Started | August 18, 2023 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT05705531 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
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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
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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.
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High-Fiber Plant-Based Diet in People with Clonal Hematopoiesis
This study tests whether a high-fiber plant-based diet can improve quality of life for adults with clonal hematopoiesis.
-
Bone density changes with anti-PD-1 immunotherapy
This pilot will test if anti-PD-1 immunotherapy changes bone density in adults starting approved anti-PD-1 treatment for certain early-stage cancers.
-
Clonal haematopoiesis assessment and long-term monitoring for prevention and care
This project will follow people aged 55 and older who have clonal haematopoiesis or unexplained low blood counts to see how their blood changes over time and whether they develop heart disease or blood cancers.
-
Pembrolizumab plus chemotherapy for frail adults with classical Hodgkin lymphoma who can't get standard treatment
This phase II trial tests whether adding pembrolizumab to gemcitabine-based chemotherapy (with possible brentuximab vedotin and dacarbazine) helps frail adults newly diagnosed with classical Hodgkin lymphoma who are ineligible for standard anthracycline-based therapy.
-
ctDNA-guided therapy for relapsed or refractory Hodgkin lymphoma using pembrolizumab with GVD
This study tests a pembrolizumab-based regimen plus chemotherapy in adults with relapsed or refractory classic Hodgkin lymphoma to see if ctDNA can guide treatment response and consolidation choices.
-
Personalized chemotherapy reduction for advanced Hodgkin lymphoma
This study is testing if people with advanced Hodgkin lymphoma can safely get fewer rounds of personalized chemotherapy based on their tumor DNA levels while still effectively treating their cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.