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A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
NCT05705531 · Children's Oncology Group
In plain English
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Official title
Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors
About this study
PRIMARY OBJECTIVES:
I. To assess the prevalence of therapy-related clonal hematopoiesis (t-CH) possessing somatic mutations associated with cardiovascular disease (CVD) in anthracycline exposed pediatric classical Hodgkin Lymphoma patients detected after front line Hodgkin Lymphoma therapy.
II. To compare rates of t-CH possessing somatic mutations associated with CVD between anthracycline exposed pediatric classical Hodgkin Lymphoma patients with versus without objective signs of CVD according to cardiac magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
I. To evaluate whether the incidence of t-CH possessing somatic mutations associated with CVD increases over time among pediatric classical Hodgkin Lymphoma patients previously treated with anthracyclines.
II. To compare rates of objective findings of CVD between groups of anthracycline exposed pediatric classical Hodgkin Lymphoma patients with versus without clinical risk factors for CVD.
EXPLORATORY OBJECTIVES:
I. To compare the prevalence of t-CH with mutations associated with CVD between anthracycline exposed pediatric classical Hodgkin Lymphoma patients who received versus did not receive mediastinal radiation as part of their initial treatment.
II. To assess whether specific patient characteristics and other treatment components (age, sex, race, dexrazoxane usage, etc.) are associated with an increased likelihood of t-CH with mutations associated with CVD.
III. To evaluate the effect of t-CH with mutations associated with CVD on objective findings of CVD, as adjusted for or mediated by other factors such as patient characteristics and clinical conditions associated with an elevated risk for CVD.
OUTLINE: This is an observational study.
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.
Eligibility 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.
Study design
Enrollment target: 190 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2023-08-18
Estimated completion: 2028-10-01
Last updated: 2026-02-24
Interventions
Procedure: Archive Sample RetrievalProcedure: Biospecimen CollectionOther: Electronic Health Record ReviewProcedure: Magnetic Resonance ImagingOther: Survey Administration
Primary outcomes
- • Therapy-related clonal hematopoiesis (t-CH) with mutations associated with cardiovascular disease (Up to 1 year)
Sponsor
Children's Oncology Group · network
Contacts & investigators
InvestigatorRobert J Hayashi · principal_investigator, Children's Oncology Group
All locations (29)
USA Health Strada Patient Care CenterRecruiting
Mobile, Alabama, United States
Phoenix Childrens HospitalRecruiting
Phoenix, Arizona, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
Alfred I duPont Hospital for ChildrenRecruiting
Wilmington, Delaware, United States
Golisano Children's Hospital of Southwest FloridaRecruiting
Fort Myers, Florida, United States
Arnold Palmer Hospital for ChildrenRecruiting
Orlando, Florida, United States
Saint Joseph's Hospital/Children's Hospital-TampaRecruiting
Tampa, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank HospitalRecruiting
Atlanta, Georgia, United States
University of Maryland/Greenebaum Cancer CenterRecruiting
Baltimore, Maryland, United States
C S Mott Children's HospitalRecruiting
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
Minneapolis, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Albany Medical CenterRecruiting
Albany, New York, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
Nationwide Children's HospitalRecruiting
Columbus, Ohio, United States
Oregon Health and Science UniversityRecruiting
Portland, Oregon, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
East Tennessee Childrens HospitalRecruiting
Knoxville, Tennessee, United States
Cook Children's Medical CenterRecruiting
Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
Houston, Texas, United States
Children's Hospital of San AntonioRecruiting
San Antonio, Texas, United States
University of Virginia Cancer CenterRecruiting
Charlottesville, Virginia, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
University of Wisconsin Carbone Cancer Center - University HospitalRecruiting
Madison, Wisconsin, United States
Hospital for Sick ChildrenSuspended
Toronto, Ontario, Canada