Non-hodgkin Lymphoma,B CellNCT06156774
SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
An observational study of Non-hodgkin Lymphoma,B Cell, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hodgkin Lymphoma,B Cell
- What is being tested?
- Chimeric Antigen Receptor T-cells (CAR-T) therapy
- How many people
- 130 participants
- Where
- 21 sitesItaly
- Study dates
- 18 Apr 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients not fulfilling the eligibility criteria
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Italy21 sites, 21 recruiting
- Recruiting
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia
Alessandria
Lucia Brunello, lucia.brunello@ospedale.al.it
- Recruiting
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona
Guido Gini, guido.gini@ospedaliriuniti.marche.itguido.gini@ospedaliriuniti.marche.it
- Recruiting
Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino
Sonya De Lorenzo, sonya.delorenzo@tin.it
- Recruiting
IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano
Michele Spina, mspina@cro.it
- Recruiting
ASST Spedali Civili di Brescia - S.C. Ematologia
Brescia
Alessandra Tucci, alessandra.tucci@asst-spedalicivili.it
- Recruiting
Ospedale di Castelfranco Veneto - Oncoematologia IOV
Castelfranco Veneto
Mariella Lo Schirico, mariella.loschirico@iov.veneto.it
- Recruiting
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence
Benedetta Puccini, puccinib@aou-careggi.toscana.it
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan
Vittorio Ruggero Zilioli, vittorioruggero.zilioli@ospedaleniguarda.it
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan
Paolo Corradini, paolo.corradini@unimi.it
- Recruiting
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan
Andres J. M. Ferreri, andres.ferreri@hsr.it
- Recruiting
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo
Luca Castagna, l.castagna@villasofia.it
- Recruiting
Ospedale S. Maria della Misericordia - Ematologia
Perugia
Leonardo Flenghi, leonardo.flenghi@ospedale.perugia.it
- Recruiting
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza
Annalisa Arcari, a.arcari@ausl.pc.it
- Not yet recruiting
AOU Pisana - U.O. Ematologia
Pisa
Enrico Orciuolo, e.orciuolo@alumni.sssup.it
- Recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia
Melissa Campanelli, Melissa.Campanelli@ausl.re.it
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
Roma
Stefan Hohaus, stefan.hohaus@Unicatt.it
- Recruiting
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma
Alice Di Rocco, dirocco@bce.uniroma1.it
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
Torino
Barbara Botto, bbotto@cittadellasalute.to.it
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia
Udine
Jacopo Olivieri, jacopo.olivieri@asufc.sanita.fvg.it
- Recruiting
AOU Integrata di Verona - U.O. Ematologia
Verona
Carlo Visco, carlo.visco@univr.it
- Recruiting
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza
Marcello Riva, marcello.riva@aulss8.veneto.it
About this study
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.
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Being tested
- Chimeric Antigen Receptor T-cells (CAR-T) therapy
- Keywords
- Non-hodgkin Lymphoma,B Cell, CAR-T, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric Antigen Receptor T-cells (CAR-T) therapyOther
Patients will be treated with CAR-T cell product as per routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rates (ORR)
Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status
Measured: up to 28 months
Secondary outcomes (5)
Best Complete Remission Rates (CRR)
Best Complete Remission Rates (CRR) after CAR-T therapy
Measured: up to 28 months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) at + 12 months after CAR-T therapy
Measured: up to 28 months
Overall Survival (OS)
Overall Survival (OS) at + 12 months after CAR-T therapy
Measured: up to 28 months
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
Measured: up to 28 months
Rate of admission to Intensive Care Units (ICU)
Rate of admission to Intensive Care Units (ICU) according to patients' sarcopenic and functional status
Measured: up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start18 Apr 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin Lymphoma,B CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Kite, A Gilead Company
- Responsible party
- Sponsor
- Investigators
- Vittorio Ruggero Zilioli, Principal investigator, ASST Grande Ospedale Metropolitano Niguarda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156774
- Sponsor's protocol ID
- FIL_SAR-CAR
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
- ClinicalTrials.gov ID
- NCT06156774
- Acronym / sponsor ID
- FIL_SAR-CAR
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Keywords
- Non-hodgkin Lymphoma,B Cell, CAR-T, Sarcopenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Kite, A Gilead Company
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Non-Hodgkin Lymphoma B cell | – | Other: Chimeric Antigen Receptor T-cells (CAR-T) therapyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not fulfilling the eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chimeric Antigen Receptor T-cells (CAR-T) therapyPatients will be treated with CAR-T cell product as per routine clinical practice. | Other | Patients with Non-Hodgkin Lymphoma B cell |
Primary outcome
Best Overall Response Rates (ORR)
Time frame: up to 28 months
Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status
5 secondary outcomes
Best Complete Remission Rates (CRR)
Time frame: up to 28 months
Progression-Free Survival (PFS)
Time frame: up to 28 months
Overall Survival (OS)
Time frame: up to 28 months
Incidence of CAR-T related toxicities
Time frame: up to 28 months
Rate of admission to Intensive Care Units (ICU)
Time frame: up to 28 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vittorio Ruggero Zilioli principal investigator
ASST Grande Ospedale Metropolitano Niguarda
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-hodgkin Lymphoma,B Cell, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rates (ORR) (time frame: up to 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.