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

NCT ID: NCT06156774

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-18

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-hodgkin Lymphoma,B Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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

Intervention Type OTHER

Patients will be treated with CAR-T cell product as per routine clinical practice.

Interventions

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

Patients will be treated with CAR-T cell product as per routine clinical practice.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kite, A Gilead Company

INDUSTRY

Sponsor Role collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vittorio Ruggero Zilioli

Role: PRINCIPAL_INVESTIGATOR

ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy

Locations

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A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia

Alessandria, , Italy

Site Status RECRUITING

AOU Ospedali Riuniti - Clinica di Ematologia

Ancona, , Italy

Site Status RECRUITING

Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

Avellino, , Italy

Site Status RECRUITING

IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati

Aviano, , Italy

Site Status RECRUITING

ASST Spedali Civili di Brescia - S.C. Ematologia

Brescia, , Italy

Site Status RECRUITING

Ospedale di Castelfranco Veneto - Oncoematologia IOV

Castelfranco Veneto, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, , Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia

Milan, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia

Milan, , Italy

Site Status RECRUITING

Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia

Milan, , Italy

Site Status RECRUITING

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

Palermo, , Italy

Site Status RECRUITING

Ospedale S. Maria della Misericordia - Ematologia

Perugia, , Italy

Site Status RECRUITING

Ospedale Guglielmo da Saliceto - U.O. Ematologia

Piacenza, , Italy

Site Status RECRUITING

AOU Pisana - U.O. Ematologia

Pisa, , Italy

Site Status NOT_YET_RECRUITING

Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

Reggio Emilia, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia

Roma, , Italy

Site Status RECRUITING

Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

Roma, , Italy

Site Status RECRUITING

A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia

Torino, , Italy

Site Status RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia

Udine, , Italy

Site Status RECRUITING

AOU Integrata di Verona - U.O. Ematologia

Verona, , Italy

Site Status RECRUITING

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

Vicenza, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Uffici Studi FIL

Role: CONTACT

+390131033153

Uffici Studi FIL

Role: CONTACT

+390599769910

Facility Contacts

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Lucia Brunello

Role: primary

Sonya De Lorenzo

Role: primary

Michele Spina

Role: primary

Alessandra Tucci

Role: primary

Mariella Lo Schirico

Role: primary

Benedetta Puccini

Role: primary

Vittorio Ruggero Zilioli

Role: primary

Paolo Corradini

Role: primary

Andres J. M. Ferreri

Role: primary

Luca Castagna

Role: primary

Leonardo Flenghi

Role: primary

Annalisa Arcari

Role: primary

Enrico Orciuolo

Role: primary

Melissa Campanelli

Role: primary

Stefan Hohaus

Role: primary

Alice Di Rocco

Role: primary

Barbara Botto

Role: primary

Jacopo Olivieri

Role: primary

Carlo Visco

Role: primary

Marcello Riva

Role: primary

Other Identifiers

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FIL_SAR-CAR

Identifier Type: -

Identifier Source: org_study_id

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