SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
1 other identifier
observational
130
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 5, 2023
CompletedStudy Start
First participant enrolled
April 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
December 8, 2025
December 1, 2025
2.2 years
November 27, 2023
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Best Complete Remission Rates (CRR)
up to 28 months
Progression-Free Survival (PFS)
up to 28 months
Overall Survival (OS)
up to 28 months
Incidence of CAR-T related toxicities
up to 28 months
Rate of admission to Intensive Care Units (ICU)
up to 28 months
Study Arms (1)
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
Interventions
Patients will be treated with CAR-T cell product as per routine clinical practice.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients not fulfilling the eligibility criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- Kite, A Gilead Companycollaborator
Study Sites (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
Florence, Italy
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan, Italy
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vittorio Ruggero Zilioli
ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 5, 2023
Study Start
April 18, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
December 8, 2025
Record last verified: 2025-12