Evaluating sarcopenia in lymphoma patients receiving CAR-T therapy
SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
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 |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | CAR-T, CART |
| Locations | 21 sites (Alessandria and 20 other locations) |
| Trial ID | NCT06156774 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with B-cell non-Hodgkin lymphoma scheduled to receive CAR-T cell therapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alessandria and 20 other locations
- 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)
- 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)
- AOU Pisana - U.O. Ematologia — Pisa, Italy (Not_yet_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)
Study contacts
- Principal investigator: Vittorio Ruggero Zilioli — ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
- Study coordinator: Uffici Studi FIL
- Email: startup@filinf.it
- Phone: +390131033153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.