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

Recruiting

• Conditions: Non-hodgkin Lymphoma,B Cell
• Interventions: Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy

• Registration Number: NCT06156774
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-05
• Study Start: 2024-04-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Non-Hodgkin Lymphoma B cell	Chimeric Antigen Receptor T-cells (CAR-T) therapy	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	up to 28 months	Overall Survival (OS) at + 12 months after CAR-T therapy
Progression-Free Survival (PFS)	up to 28 months	Progression-Free Survival (PFS) at + 12 months after CAR-T therapy
Best Complete Remission Rates (CRR)	up to 28 months	Best Complete Remission Rates (CRR) after CAR-T therapy
Incidence of CAR-T related toxicities	up to 28 months	Incidence of CAR-T related toxicities (specifically: CRS, ICANS, cytopenias) in the different sarcopenic subgroups and, for patients ≥65 years old, according to their functional status
Rate of admission to Intensive Care Units (ICU)	up to 28 months	Rate of admission to Intensive Care Units (ICU) according to patients' sarcopenic and functional status

Trial Locations

Locations (21)

A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia; 🇮🇹 Alessandria, Italy

AOU Ospedali Riuniti - Clinica di Ematologia; 🇮🇹 Ancona, Italy

Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico; 🇮🇹 Avellino, Italy

IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati; 🇮🇹 Aviano, Italy

ASST Spedali Civili di Brescia - S.C. Ematologia; 🇮🇹 Brescia, Italy

Ospedale di Castelfranco Veneto - Oncoematologia IOV; 🇮🇹 Castelfranco Veneto, Italy

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia; 🇮🇹 Firenze, Italy

ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia; 🇮🇹 Milano, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia; 🇮🇹 Milano, Italy

Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia; 🇮🇹 Milano, Italy

A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia; 🇮🇹 Palermo, Italy

Ospedale S. Maria della Misericordia - Ematologia; 🇮🇹 Perugia, Italy

Ospedale Guglielmo da Saliceto - U.O. Ematologia; 🇮🇹 Piacenza, Italy

AOU Pisana - U.O. Ematologia; 🇮🇹 Pisa, Italy

Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia; 🇮🇹 Reggio Emilia, Italy

Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia; 🇮🇹 Roma, Italy

Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione; 🇮🇹 Roma, Italy

A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia; 🇮🇹 Torino, Italy

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia; 🇮🇹 Udine, Italy

AOU Integrata di Verona - U.O. Ematologia; 🇮🇹 Verona, Italy

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia; 🇮🇹 Vicenza, Italy