Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-21
Brief Title:
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cardio CAR-T
Brief 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
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
Detailed Description:
CAR-T cells Chimeric Antigen Receptor represent a new form of immunotherapy based on the genetic modification of autologous T lymphocytes collected after apheresis allowing the recognition of a tumor antigen apart from the presentation by the major complex of histocompatibility MHC Treatment with CAR-T cells constitutes a major therapeutic advance in patients with refractory hematological malignancies
Nevertheless CAR-T cell therapy is often associated with severe complications leading them to the ICU in 25
Among the most frequent complications are the risk of infection cytokine release syndrome CRSand neurotoxicity A recent study reported serious acute cardiac events in the days following the administration of CAR-T cells in 65 of patients 12187 In this work patients did not benefit from systematic early echocardiography but only in the event of CRS grade 2 or symptoms with a risk of underdiagnosis of asymptomatic forms Since the vast majority of reported cases are contemporaneous with CRS or sepsis the imputability of CAR-Ts in this heart disease is debated
The Cardio CAR-T study aims to investigate a possible early cardiac toxicity of CAR-T cells screened by transthoracic echocardiography at the patients bedside between D3 and D5 after injection of CAR-T cells period at which the inflammatory complications of this treatment occur in the majority of cases associated with the description of routine examinations BNP Troponin and ECG and cytokine analyses
This pilot descriptive study would answer 2 questions
What are the incidence and characteristics of acute cardiac toxicity clinical and subclinical of CAR-T cells and their association with CRS
Is there a link between cardiac toxicity and the intensity of the cytokine inflammatory response This makes it possible to provide new pathophysiological elements on the existence of a heart disease directly caused by the inflammatory storm applicable to other areas such as septic shock ischemia-reperfusion or major surgery
Nevertheless CAR-T cell therapy is often associated with severe complications leading them to the ICU in 25
Among the most frequent complications are the risk of infection cytokine release syndrome CRSand neurotoxicity A recent study reported serious acute cardiac events in the days following the administration of CAR-T cells in 65 of patients 12187 In this work patients did not benefit from systematic early echocardiography but only in the event of CRS grade 2 or symptoms with a risk of underdiagnosis of asymptomatic forms Since the vast majority of reported cases are contemporaneous with CRS or sepsis the imputability of CAR-Ts in this heart disease is debated
The Cardio CAR-T study aims to investigate a possible early cardiac toxicity of CAR-T cells screened by transthoracic echocardiography at the patients bedside between D3 and D5 after injection of CAR-T cells period at which the inflammatory complications of this treatment occur in the majority of cases associated with the description of routine examinations BNP Troponin and ECG and cytokine analyses
This pilot descriptive study would answer 2 questions
What are the incidence and characteristics of acute cardiac toxicity clinical and subclinical of CAR-T cells and their association with CRS
Is there a link between cardiac toxicity and the intensity of the cytokine inflammatory response This makes it possible to provide new pathophysiological elements on the existence of a heart disease directly caused by the inflammatory storm applicable to other areas such as septic shock ischemia-reperfusion or major surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB 2023-A01957-38 | OTHER | ANSM | None |