SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project

Study Overview
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Brief Summary
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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.

Official Title
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SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project

Conditions
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Non-hodgkin Lymphoma,B Cell

Intervention / Treatment
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* Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients not fulfilling the eligibility criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Non-Hodgkin Lymphoma B cell<br>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 | Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy<br>* Patients will be treated with CAR-T cell product as per routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response Rates (ORR) | Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status | up to 28 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Complete Remission Rates (CRR) | Best Complete Remission Rates (CRR) after CAR-T therapy | up to 28 months | 
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) at + 12 months after CAR-T therapy | up to 28 months | 
| Overall Survival (OS) | Overall Survival (OS) at + 12 months after CAR-T therapy | up to 28 months | 
| 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 | up to 28 months | 
| Rate of admission to Intensive Care Units (ICU) | Rate of admission to Intensive Care Units (ICU) according to patients' sarcopenic and functional status | up to 28 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-hodgkin Lymphoma,B Cell, CAR-T, Sarcopenia