Status:

NOT_YET_RECRUITING

CAR-T Cell Induced Cardiac Dysfunction: A Prospective Study

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

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...

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, a...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

November 2 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT06106776

Start Date

November 2 2023

End Date

January 31 2026

Last Update

October 30 2023

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