Lymphoma
Conditions
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.
Interventions
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).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed