An observational study in Cardiovascular Diseases, B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoma Refractory, sponsored by University College London Hospitals. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by University College London Hospitals · Observational
This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.
CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.
This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up.
The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 150 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →University College London Hospitals is the lead sponsor of 61 studies on the registry; 9 are open to participants now.
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All patients receiving CD19-specific CAR T cell therapy for the management of relapsing or refractory haematological malignancy at the MacMillan Cancer Centre within the University College London Hospital will be considered for participation.
Exclusion Criteria:
Detected abnormalities - Composite
The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.
Time frame: 3 months
Detected abnormalities - Individual
The secondary outcome measures includes a composite of detected abnormalities of factors on cardiac biomarkers (troponin and N-terminal pro B-type natriuretic peptide) , electrocardiogram (ECG) changes and acute heart failure.
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University College London Hospitals