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Clinical Trials in France / NCT06350994
Recruiting Observational

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

NCT06350994 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2024-11-07
Last updated
2025-09-02

Condition(s) studied

Car T- CellHematologic MalignancyAcute Lymphoblastic LeukemiaLymphoma, B-CellMultiple Myeloma

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity — 5 days and 3 months
    Transthoracic bedside echocardiographic evaluation of the LVEF.

Trial sites (1)

FacilityCityRegionStatus
Critical care medicine department Paris France Recruiting

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An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Active, not recruiting
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Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06350994 on ClinicalTrials.gov ↗ ← All trials in France