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

Non-hodgkin Lymphoma,B Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06156774
• Other study ID #: FIL_SAR-CAR
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: July 2026

Study information

• Verified date: November 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: Uffici Studi FIL
• Phone: +390131033153
• Email: startup[@]filinf.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma,B Cell
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Italy	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

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS	Kite, A Gilead Company

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response Rates (ORR)	Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status	up to 28 months
Secondary	Best Complete Remission Rates (CRR)	Best Complete Remission Rates (CRR) after CAR-T therapy	up to 28 months
Secondary	Progression-Free Survival (PFS)	Progression-Free Survival (PFS) at + 12 months after CAR-T therapy	up to 28 months
Secondary	Overall Survival (OS)	Overall Survival (OS) at + 12 months after CAR-T therapy	up to 28 months
Secondary	Incidence of CAR-T related toxicities	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	up to 28 months
Secondary	Rate of admission to Intensive Care Units (ICU)	Rate of admission to Intensive Care Units (ICU) according to patients' sarcopenic and functional status	up to 28 months