A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorChildren's Oncology Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m² 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.
Disqualifiers
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.
Trial population
Patients with pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \>= 2 and \< 22 years of age
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Archive Sample Retrieval
Procedure/SurgeryUndergo collection of archived blood sample
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Electronic Health Record Review
Other interventionUndergo medical record abstraction
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Survey Administration
Other interventionComplete surveys
Treatment groups
190 Participants
are divided into 1 treatment groupGroup A: Observational (blood samples, surveys, MRI, record review)5 interventions
Trial outcomes
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.
Time frame
Up to 1 yearSecondary outcomes
1
Expansion of CH
The outcome is the expansion of the CH, which will be expressed as the variant allele fraction (VAF) (CH verses the total normal DNA in the sample). Graphic analysis to reveal the time varying trend in the association between the expansion of CH over time and the presence/worsening of CVD signs and apply generalized estimating equation method (with each patient as cluster unit) to quantify this association while controlling for the potential correlation of repeated measurements within each patient.
Time frame
Up to 1 year2
Association between the presence of CVD and individual variables
The outcome is the presence of CVD. This aim is to determine if there is an association between the presence of CVD and the individual variables constituting the clinical profile, either parametric (e.g., independent t-test, Chi\^2-test, Pearson correlation coefficients) or nonparametric (e.g., Wilcoxon rank sum tests, Spearman's rank correlation coefficients) methods will be applied. Bootstrapping techniques might be used as a method of inference which does not rely on a specific underlying distribution. The statistical significance level will be set to 0.05 and all data analysis will be done using SAS statistical software (version 9.4).
Time frame
Up to 1 yearOther outcomes
1
Prevalence and nature of CVD, CH and CH with mutations associated with cardiovascular disease
The outcome is the expansion of the CH, which will be expressed as the variant allele fraction (VAF) (CH verses the total normal DNA in the sample). The VAFs and their exact 90% (Clopper-Pearson) confidence intervals are used to summarize the prevalence and nature of CVD, CH and CH with mutations associated with CVD for patients receiving mediastinal radiation.
Time frame
Up to 1 year2
Patient characteristics and treatments
The outcome here is the incidence of t-CH with mutation. The specific patient characteristic and treatments (age, sex, race, dexrazoxane usage etc.) will be used to predict the incidence of t-CH with mutation rate. Regression model will be constructed to evaluate the effect of these patient characteristics and treatments on the incidence of t-CH with mutation rate, which will be presented by p-values, coefficients and their confidence intervals.
Time frame
Up to 1 year3
Effect of therapy-related clonal hematopoiesis on cardiovascular disease
The outcome is the cardiovascular disease defined by cMRI. This aim is to evaluate the effect of other covariates such as patient characteristics (age, sex, race, etc.) and clinical conditions (radiation treatment with cardiac dosimetry, follow-up duration, etc.) on cardiovascular disease.
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov