CAR T Cell Therapy Related Cardiovascular Outcomes

Cardiovascular Diseases Clinical Trial

— CARTCO  

Official title:

Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130489
• Other study ID #: 20/SC/0301
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• B-cell Lymphoma Recurrent
• B-cell Lymphoma Refractory
• Cardiotoxicity
• Cardiovascular Complication
• Cardiovascular Diseases
• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals	London

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

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