This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.
Adult patients (≥ 18 years old).
Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
Availability of a 18F-FDG PET/CT scan or a full dose CT scan (without contrast media) pre-treatment with CART
Written informed consent voluntarily provided
Patients not fulfilling the eligibility criteria
Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
Cohort
Prospective
Chimeric Antigen Receptor T-cells (CAR-T) therapy
Other interventionPatients will be treated with CAR-T cell product as per routine clinical practice.
Best Overall Response Rates (ORR)
Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status
Best Complete Remission Rates (CRR)
Best Complete Remission Rates (CRR) after CAR-T therapy
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) at + 12 months after CAR-T therapy
Overall Survival (OS)
Overall Survival (OS) at + 12 months after CAR-T therapy
Incidence of CAR-T related toxicities
Incidence of CAR-T related toxicities (specifically: CRS, ICANS, cytopenias) in the different sarcopenic subgroups and, for patients ≥65 years old, according to their functional status
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Fondazione Italiana Linfomi - ETS
Lead sponsor
Kite, A Gilead Company
Collaborator
