About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Opposition or consent withdrawal
Trial population
Adult patients (\>18 years old) receiving CAR-T cell therapy for hematological malignancies (acute lymphoblastic -B cell leukemia, lymphoma and multiple myeloma) hospitalized in hematology department or in intensive care unit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity
Transthoracic bedside echocardiographic evaluation of the LVEF.
Secondary outcomes
Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations
Transthoracic bedside echocardiographic evaluation of the LVEF, EKG, biologicals (troponin, BNP).
Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients
Multiplex bioassays for immune-inflammatory biomarkers.
Sponsors and contacts
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