SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Other: Chimeric Antigen Receptor T-cells (CAR-T) therapy
Patients will be treated with CAR-T cell product as per routine clinical practice.
|
Outcome Measures
Primary Outcome Measures
- Best Overall Response Rates (ORR) [up to 28 months]
Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status
Secondary Outcome Measures
- Best Complete Remission Rates (CRR) [up to 28 months]
Best Complete Remission Rates (CRR) after CAR-T therapy
- Progression-Free Survival (PFS) [up to 28 months]
Progression-Free Survival (PFS) at + 12 months after CAR-T therapy
- Overall Survival (OS) [up to 28 months]
Overall Survival (OS) at + 12 months after CAR-T therapy
- Incidence of CAR-T related toxicities [up to 28 months]
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
- Rate of admission to Intensive Care Units (ICU) [up to 28 months]
Rate of admission to Intensive Care Units (ICU) according to patients' sarcopenic and functional status
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia | Alessandria | Italy | ||
| 2 | AOU Ospedali Riuniti - Clinica di Ematologia | Ancona | Italy | ||
| 3 | Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico | Avellino | Italy | ||
| 4 | IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati | Aviano | Italy | ||
| 5 | ASST Spedali Civili di Brescia - S.C. Ematologia | Brescia | Italy | ||
| 6 | Ospedale di Castelfranco Veneto - Oncoematologia IOV | Castelfranco Veneto | Italy | ||
| 7 | Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia | Firenze | Italy | ||
| 8 | ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia | Milano | Italy | ||
| 9 | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia | Milano | Italy | ||
| 10 | Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia | Milano | Italy | ||
| 11 | A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia | Palermo | Italy | ||
| 12 | Ospedale S. Maria della Misericordia - Ematologia | Perugia | Italy | ||
| 13 | Ospedale Guglielmo da Saliceto - U.O. Ematologia | Piacenza | Italy | ||
| 14 | AOU Pisana - U.O. Ematologia | Pisa | Italy | ||
| 15 | Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia | Reggio Emilia | Italy | ||
| 16 | Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia | Roma | Italy | ||
| 17 | Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione | Roma | Italy | ||
| 18 | A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia | Torino | Italy | ||
| 19 | Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia | Udine | Italy | ||
| 20 | AOU Integrata di Verona - U.O. Ematologia | Verona | Italy | ||
| 21 | ULSS 8 Berica - Ospedale S. Bortolo - Ematologia | Vicenza | Italy |
Sponsors and Collaborators
- Fondazione Italiana Linfomi - ETS
- Kite, A Gilead Company
Investigators
- Principal Investigator: Vittorio Ruggero Zilioli, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FIL_SAR-CAR