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Early Assessment of Cardiac Function After Treatment With CAR-T Cells

Recruitingn/aAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06350994 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications. Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease. This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells. The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5).

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📋 Eligibility rules (as published)
Inclusion Criteria: * CAR-T cells infusion received within 3 to 5 days before the echocardiography * Pre-therapeutic cardiac assessment (in accordance with the recommendations and standard care protocol in force in the hematology department of Saint-Antoine Hospital): Echocardiography and EKG before conditioning and infusion of CAR -T cells, * Not opposed to participating in research. * Patient affiliated to a social security system or beneficiary of the "state medical insurance help" (namely aide médicale d'état). Exclusion Criteria: * Opposition or consent withdrawal
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What it tests

  • Not listed
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Where

1 site
Critical care medicine department
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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