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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi - ETS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kite, A Gilead Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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