Clinical trial NCT06156774: SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
Official title: SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-hodgkin Lymphoma,B Cell
Keywords: Non-hodgkin Lymphoma,B Cell
CAR-T
Sarcopenia
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Kite, A Gilead Company
First posted: 2023-12-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility 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

Primary outcomes:
measure: Best Overall Response Rates (ORR)
timeFrame: up to 28 months
Secondary outcomes:
measure: Best Complete Remission Rates (CRR)
timeFrame: up to 28 months
measure: Progression-Free Survival (PFS)
timeFrame: up to 28 months
measure: Overall Survival (OS)
timeFrame: up to 28 months
measure: Incidence of CAR-T related toxicities
timeFrame: up to 28 months
measure: Rate of admission to Intensive Care Units (ICU)
timeFrame: up to 28 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti - Clinica di Ematologia
city: Avellino
country: Italy
facility: Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - S.C. Ematologia
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Veneto - Oncoematologia IOV
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia - Ematologia
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto - U.O. Ematologia
city: Pisa
country: Italy
facility: AOU Pisana - U.O. Ematologia
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
city: Roma
country: Italy
facility: Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia
city: Verona
country: Italy
facility: AOU Integrata di Verona - U.O. Ematologia
city: Vicenza
country: Italy
facility: ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Study officials:
affiliation: ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
name: Vittorio Ruggero Zilioli
role: PRINCIPAL_INVESTIGATOR
References: