Ireland
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Latest
Recruiting Observational

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

NCT06156774 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-04-18
Last updated
2025-12-08

Condition(s) studied

Non-hodgkin Lymphoma,B Cell

Investigational drug(s) / intervention(s)

Chimeric Antigen Receptor T-cells (CAR-T) therapy

Chimeric Antigen Receptor T-cells (CAR-T) therapy: Patients will be treated with CAR-T cell product as per routine clinical practice.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Best Overall Response Rates (ORR) — up to 28 months
    Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status

Trial sites (21)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06156774 on ClinicalTrials.gov ↗ ← All trials in Italy