Condition: Car T- Cell · Hematologic Malignancy · Acute Lymphoblastic Leukemia · Sponsor: Assistance Publique - Hôpitaux de Paris
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).
This description comes directly from the study's public registry record.
Jérémie JOFFRE, MD, PhD · +33 1 49 28 21 45 · Jeremie.joffre@aphp.fr
Hafid AIT-OUFELLA, Professor · +33 1 49 28 21 45 · hafid.ait-oufella@aphp.fr
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| Critical care medicine department | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06350994