CAR T Cell Therapy Related Cardiovascular Outcomes

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.

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Key information

Conditions

Cardiovascular Diseases B-cell Acute Lymphoblastic Leukemia B-cell Lymphoma Recurrent B-cell Lymphoma Refractory Burkitt Lymphoma Cardiotoxicity Cardiovascular Complication Chemically-Induced Disorders DNA Virus Infections Diffuse Large B Cell Lymphoma Drug-Related Side Effects and Adverse Reactions Epstein-Barr Virus Infections Heart Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Mediastinal Large B-cell Lymphoma (PMBCL) Radiation Injuries Tumor Virus Infections Virus Diseases Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London Hospitals

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Detected abnormalities - Composite

Time frame: 3 months

The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.

Secondary outcomes

Detected abnormalities - Individual

Time frame: 3 months

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.

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Registry information

Official study title

Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes

Acronym: CARTCO

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Nov 23, 2021
Registry last updated: May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed