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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Cardio CAR-T

Trial outcomes

Primary outcomes

1

Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity

Transthoracic bedside echocardiographic evaluation of the LVEF.

Time frame
5 days and 3 months

Secondary outcomes

1

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).

Time frame
5 days and 3 months
2

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.

Time frame
5 days and 3 months

Other outcomes

Sponsors and contacts

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