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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Critical care medicine department
RECRUITING
Paris
Contact Information
Primary
Jérémie JOFFRE, MD, PhD
Jeremie.joffre@aphp.fr
+33 1 49 28 21 45
Backup
Hafid AIT-OUFELLA, Professor
hafid.ait-oufella@aphp.fr
+33 1 49 28 21 45
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2027-03
Participants
Target number of participants: 60
Treatments
Cardio CAR-T
Transthoracic bedside echocardiography
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

Similar Clinical Trials