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

December 1, 2025 updated by: Fondazione Italiana Linfomi - ETS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
      • Ancona, Italy
      • Avellino, Italy
        • Recruiting
        • Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
        • Contact:
      • Aviano, Italy
        • Recruiting
        • IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
        • Contact:
      • Brescia, Italy
      • Castelfranco Veneto, Italy
      • Florence, Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
        • Contact:
      • Milan, Italy
        • Recruiting
        • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
        • Contact:
      • Milan, Italy
      • Palermo, Italy
        • Recruiting
        • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
        • Contact:
      • Perugia, Italy
      • Piacenza, Italy
        • Recruiting
        • Ospedale Guglielmo da Saliceto - U.O. Ematologia
        • Contact:
      • Pisa, Italy
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
        • Contact:
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
        • Contact:
      • Torino, Italy
      • Udine, Italy
      • Verona, Italy
        • Recruiting
        • AOU Integrata di Verona - U.O. Ematologia
        • Contact:
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Non-Hodgkin Lymphoma B cell
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
Patients will be treated with CAR-T cell product as per routine clinical practice.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Collaborators

Kite, A Gilead Company

Investigators

  • Principal Investigator: Vittorio Ruggero Zilioli, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_SAR-CAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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