Recruiting NCT06156774
SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chimeric Antigen Receptor T-cells (CAR-T) therapy.
- Who it may be relevant to
- Registry conditions: Non-hodgkin Lymphoma,B Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Chimeric Antigen Receptor T-cells (CAR-T) therapy
Patients will be treated with CAR-T cell product as per routine clinical practice.
Primary outcome measures
- Best Overall Response Rates (ORR) [Time frame: up to 28 months]
Secondary outcome measures (5)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 21 centers
- A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia — Alessandria
- AOU Ospedali Riuniti - Clinica di Ematologia — Ancona
- Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico — Avellino
- IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori imm — Aviano
- ASST Spedali Civili di Brescia - S.C. Ematologia — Brescia
- Ospedale di Castelfranco Veneto - Oncoematologia IOV — Castelfranco Veneto
- Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia — Florence
- ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia — Milan
- … and 13 more centers
Identifiers
NCT: NCT06156774 · FIL_SAR-CAR