Clinical trial NCT05705531: A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
Official title: Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Disorder
Clonal Hematopoiesis
Hodgkin Lymphoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
First posted: 2023-01-30
Enrollment: 230
Sex: ALL
Minimum age (years): 7
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prior to enrollment on this study, patients must have been enrolled on AHOD1331.

Brief summary: This study assesses how blood cell growth patterns (clonal hematopoiesis), relates 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.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the prevalence of participants in AHOD1331 with therapy-related clonal hematopoiesis (t-CH) possessing somatic mutations associated with cardiovascular disease (CVD) which are detected after Hodgkin Lymphoma therapy.

II. To assess participants of AHOD1331 with t-CH for the presence or absence of objective signs of CVD using cardiac magnetic resonance imaging (MRI).

SECONDARY OBJECTIVES:

I. To assess whether participants in AHOD1331 with t-CH expand this population over time and possess objective findings of CVD.

II. To assess whether patients both with and without objective findings of CVD using cardiac MRI possess clinical risk factors for CVD.

EXPLORATORY OBJECTIVES:

I. To assess the prevalence of patients receiving mediastinal radiation who have objective findings of CVD using cardiac MRI, that also possess t-CH with mutations associated with CVD.

II. To assess whether specific patient characteristics and treatment (age, gender, race, dexrazoxane usage, etc.) correlate with a higher incidence of t-CH with mutations associated with CVD.

III. To assess the effects of t-CH on CVD by considering 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.

Eligibility criteria: Inclusion Criteria:

* Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).
* Enrolled and completed therapy on AHOD1331.
* Not known to have had a primary event (relapse/second malignancy/death). Note: Subjects enrolled and/or treated on AHOD1331 at another institution are eligible if they are now being followed at the current Children's Oncology Group (COG) institution.
* Patient must have access to cardiac MRI at institution where receiving follow-up care and must be able to complete cardiac MRI without sedation.
* All patients and/or their parents or legal guardians must sign a written informed consent.
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Medical contraindication to undergoing a cardiac MRI.
* Removed from AHOD1331 therapy prior to completing the AHOD1331 protocol specified treatment plan.
* Received cancer therapy in addition to that of AHOD1331 (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).
* History of cardiovascular disease prior to enrollment on AHOD1331.

Primary outcomes:
measure: Proportion of therapy-related clonal hematopoiesis (t-CH) for patients with cardiovascular disease (CVD) after Hodgkin Lymphoma therapy
timeFrame: Up to 1 year
measure: Proportion of t-CH with mutations for patients with CVD after Hodgkin Lymphoma therapy
timeFrame: Up to 1 year
measure: Proportion of t-CH for patients without CVD after Hodgkin Lymphoma therapy
timeFrame: Up to 1 year
measure: Proportion of t-CH with mutations for patients without CVD after Hodgkin Lymphoma therapy
timeFrame: Up to 1 year
measure: Objective signs of CVD
timeFrame: Up to 1 year
measure: Objective signs of CVD
timeFrame: Up to 1 year
measure: Objective signs of CVD
timeFrame: Up to 1 year
Secondary outcomes:
measure: Expansion of CH
timeFrame: Up to 1 year
measure: Association between the presence of CVD and individual variables
timeFrame: Up to 1 year
Other outcomes:
measure: Prevalence and nature of CVD, CH and CH with mutations associated with cardiovascular disease
timeFrame: Up to 1 year
measure: Patient characteristics and treatments
timeFrame: Up to 1 year
measure: Effect of therapy-related clonal hematopoiesis on cardiovascular disease
timeFrame: Up to 1 year
Locations:
city: Mobile
country: United States
facility: USA Health Strada Patient Care Center
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Childrens Hospital
state: Arizona
city: Wilmington
country: United States
facility: Alfred I duPont Hospital for Children
state: Delaware
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Tampa
country: United States
facility: Saint Joseph's Hospital/Children's Hospital-Tampa
state: Florida
city: Ann Arbor
country: United States
facility: C S Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota - Minneapolis
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Knoxville
country: United States
facility: East Tennessee Childrens Hospital
state: Tennessee
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Children's Hospital of San Antonio
state: Texas
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Children's Oncology Group
name: Robert J Hayashi
role: PRINCIPAL_INVESTIGATOR
References: