CARdio-Tox: CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06106776

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Chimeric Antigen Receptor

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

48 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Nov 2, 2024

Anticipated Study Completion Date :

Jan 31, 2026

Outcome Measures

Primary Outcome Measures

Incidence of Cancer Therapy Related Cardiac Dysfunction [30 days]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT06106776

Other Study ID Numbers:

6000

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 30, 2023