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ALTE21C1, Assessment of Clonal Hematopoiesis and its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors

Primary Investigator
Walling, Emily
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT05705531
UM Number
2023.087
Age Group
Children
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
49637
Secondary Protocol No
HUM00240948
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Hodgkin's Lymphoma
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.

Eligibility: 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.