CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

Study Overview
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Brief Summary
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In this observational, prospective study, patients affected by B-cell Lymphoma and candidate to chimeric antigen receptor-T (CAR-T) cell infusion will be evaluated at three timepoints to establish the rate of cardiac dysfunction, defined according to 2022 European Society of Cardiology Cardio-Oncology guidelines. Echocardiography, physical examination and cardiac/inflammatory biomarkers will be performed prior to CAR-T cell infusion and followed at 7 days and 1 month.

Detailed Description
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Patients will perform clinical evaluation, transthoracic echocardiogram with speckle tracking analysis and blood samples (including cardiac biomarkers of damage and fibrosis) prior to CART infusion, after 7 days and 1 month following CART infusion. Rate of Cytokine Release Syndrome and use of interleukin-6 inhibitors will be also registered.

Official Title
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PROSPECTIVE OBSERVATIONAL STUDY FOR THE ASSESSMENT OF CARDIAC DYSFUNCTION INDUCED BY CHIMERIC ANTIGEN RECEPTOR T (CAR-T) CELL THERAPY

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Chimeric Antigen Receptor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 years old; Patients affected by relapsed and/or refractory diffuse large B-cell lymphoma, follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma or B-cell lymphoblastic leukemia, candidate treatment with chimeric antigen receptor-T cell therapy at the Hematology division of Policlinico Universitario Agostino Gemelli, Rome; Patients with left ventricular ejection fraction >50%. Exclusion Criteria: Age<18 years old; Patients who denied to participate to the study; Patients with left ventricular ejection fraction<50%.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chimeric Antigen Receptor|This study will evaluate the incidence of cardiac dysfunction at 7 days and 1 month after chimeric antigen receptor-T cell infusion (tisagenlecleucel, axicabtagene ciloleucel e brexucabtagene autoleucel).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cancer Therapy Related Cardiac Dysfunction | Cancer Therapy Related Cardiac Dysfunction will be defined according to 2022 European Society of Cardiology guidelines, as symptomatic or asymptomatic and mild, moderate or severe. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with Inflammatory Biomarkers | Modifications of echocardiographic metrics will be related to inflammatory biomarkers (interleukin2 soluble receptor, interleukin 6, fibrinogen, C-reactive protein) changes. | 30 days | 
| Correlation with Cytokine Release Syndrome Occurrence | Incidence of cardiotoxicity will be related to occurrence and severity of Cytokine Release Syndrome | 30 days |