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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | CAR-T, CART |
| Locations | 21 sites (Alessandria and 20 other locations) |
| Status | Recruiting |
| Started | April 18, 2024 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT06156774 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
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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
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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.
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In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma
This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.
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Universal CAR-T therapy for CD19-positive B‑cell non-Hodgkin lymphoma
This study will try an off‑the‑shelf CAR‑T product called BRL‑301 in adults with CD19‑positive B‑cell non‑Hodgkin lymphoma to see if a single 5×10^6/kg dose is safe and shows anti‑tumor activity.
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CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma
This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.
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Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T
This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.
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CD7 CAR T-Cell Therapy for T-Cell Lymphomas
This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.
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This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.