Cardiovascular Diseases Clinical Trial
— CARTCOOfficial title:
Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes
NCT number | NCT05130489 |
Other study ID # | 20/SC/0301 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 18, 2021 |
Est. completion date | May 1, 2023 |
Verified date | May 2023 |
Source | University College London Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Patients with capacity, (aged 16 and older) - Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies Exclusion Criteria: - Patients under 16 years |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospitals | London |
Lead Sponsor | Collaborator |
---|---|
University College London Hospitals |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Secondary | 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. | 3 months |
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