CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

NCT ID: NCT06106776

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2026-01-31

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.

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.

Conditions

Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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%.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

6000

Identifier Type: -

Identifier Source: org_study_id