CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

NCT06106776 | Unknown

• 1 other identifier: 6000
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation with Inflammatory Biomarkers

  30 days

• Correlation with Cytokine Release Syndrome Occurrence

  30 days

Interventions

Chimeric Antigen Receptor DRUG

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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, scheduled to receive treatment with chimeric antigen receptor-T cell therapy at the Hematology division of Policlinico Universitario Agostino Gemelli, Rome will be firstly evaluated. If they exclusion criteria are not present, the will be included in the study protocol and evaluated by the Cardio-Oncology outpatient service.

You may qualify if:

• 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%.

You may not qualify if:

• Age\<18 years old;
• Patients who denied to participate to the study;
• Patients with left ventricular ejection fraction\<50%.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Lymphoma

Interventions

Receptors, Chimeric Antigen

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Receptors, Artificial; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Antigen, T-Cell; Receptors, Antigen; Receptors, Immunologic; Receptors, Cytoplasmic and Nuclear

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 2, 2023
• Primary Completion: November 2, 2024
• Study Completion: January 31, 2026
• Last Updated: October 30, 2023

Record last verified: 2023-10