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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06156774

Enrollment

130

Registered

2023-12-05

Start date

2024-04-18

Completion date

2026-07-31

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-hodgkin Lymphoma,B Cell

Keywords

Non-hodgkin Lymphoma,B Cell, CAR-T, Sarcopenia

Brief summary

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.

Interventions

OTHERChimeric Antigen Receptor T-cells (CAR-T) therapy

Patients will be treated with CAR-T cell product as per routine clinical practice.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

Primary ContactUffici Studi FIL

startup@filinf.it+390131033153

Backup ContactUffici Studi FIL

gestionestudi@filinf.it+390599769910

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026