Clinical trial Recruiting at 20 sites Observational Ages 18 and up

Evaluating sarcopenia in lymphoma patients receiving CAR-T therapy

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

Run by Fondazione Italiana Linfomi - ETS · NCT06156774 · Data updated 2026-11-12

This study is trying to see if measuring muscle loss and overall health can help predict how well CAR-T therapy works and what side effects it might cause in adults with B-cell non-Hodgkin lymphoma.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment130 (estimated)
SponsorFondazione Italiana Linfomi - ETS
Academic / other
Drugs / interventionsCAR-T, CART
Locations21 sites (Alessandria and 20 other locations)
StatusRecruiting
StartedApril 18, 2024
Main results expectedJuly 2026
Study endsJuly 2026
Registry record updatedDecember 8, 2025
Trial IDNCT06156774 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with B-cell non-Hodgkin lymphoma scheduled to receive CAR-T cell therapy.

Probably not a fit

Patients who do not meet the eligibility criteria or those with conditions unrelated to sarcopenia or lymphoma may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to assess sarcopenia and simplified geriatric assessment (sGA) as potential predictors of treatment efficacy and toxicity in adult patients with B-cell non-Hodgkin lymphoma undergoing CAR-T cell therapy. Participants will be evaluated based on their physical condition and treatment outcomes, utilizing pre-treatment imaging to gather relevant data. The study seeks to identify factors that may influence the success of CAR-T therapy in this patient population.

Why it matters

Potential benefit: If successful, this study could help identify patients at risk for poor outcomes from CAR-T therapy, allowing for tailored treatment approaches.

How similar studies have gone: While the specific approach of assessing sarcopenia in this context may be novel, similar studies have shown the importance of physical condition in treatment outcomes for cancer therapies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia
    Alessandria, Italy
    Recruiting
  • AOU Ospedali Riuniti - Clinica di Ematologia
    Ancona, Italy
    Recruiting
  • Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
    Avellino, Italy
    Recruiting
  • IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
    Aviano, Italy
    Recruiting
  • ASST Spedali Civili di Brescia - S.C. Ematologia
    Brescia, Italy
    Recruiting
  • Ospedale di Castelfranco Veneto - Oncoematologia IOV
    Castelfranco Veneto, Italy
    Recruiting
Show 15 more locations
  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
    Florence, Italy
    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
    Milan, Italy
    Recruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
    Milan, Italy
    Recruiting
  • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
    Milan, Italy
    Recruiting
  • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
    Palermo, Italy
    Recruiting
  • Ospedale S. Maria della Misericordia - Ematologia
    Perugia, Italy
    Recruiting
  • Ospedale Guglielmo da Saliceto - U.O. Ematologia
    Piacenza, Italy
    Recruiting
  • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
    Reggio Emilia, Italy
    Recruiting
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
    Roma, Italy
    Recruiting
  • Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
    Roma, Italy
    Recruiting
  • A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
    Torino, Italy
    Recruiting
  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia
    Udine, Italy
    Recruiting
  • AOU Integrata di Verona - U.O. Ematologia
    Verona, Italy
    Recruiting
  • ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
    Vicenza, Italy
    Recruiting
  • AOU Pisana - U.O. Ematologia
    Pisa, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Vittorio Ruggero Zilioli — ASST Grande Ospedale Metropolitano Niguarda
  • Study coordinator: Uffici Studi FIL
  • Email: startup@filinf.it
  • Phone: +390131033153

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.