Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with Inflammatory Biomarkers | Modifications of echocardiographic metrics will be related to inflammatory biomarkers (interleukin2 soluble receptor, interleukin 6, fibrinogen, C-reactive protein) changes. | 30 days |
| Correlation with Cytokine Release Syndrome Occurrence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000076962 | Receptors, Chimeric Antigen |
| ID | Term |
|---|---|
| D062165 | Receptors, Artificial |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Incidence of cardiotoxicity will be related to occurrence and severity of Cytokine Release Syndrome |
| 30 days |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011948 | Receptors, Antigen, T-Cell |
| D011946 | Receptors, Antigen |
| D011971 | Receptors, Immunologic |
| D018160 | Receptors, Cytoplasmic and Nuclear |