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| Name | Class |
|---|---|
| Kite, A Gilead Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric Antigen Receptor T-cells (CAR-T) therapy | Other | Patients will be treated with CAR-T cell product as per routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best Complete Remission Rates (CRR) | Best Complete Remission Rates (CRR) after CAR-T therapy | up to 28 months |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) at + 12 months after CAR-T therapy |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uffici Studi FIL | Contact | +390131033153 | startup@filinf.it | |
| Uffici Studi FIL | Contact | +390599769910 | gestionestudi@filinf.it |
| Name | Affiliation | Role |
|---|---|---|
| Vittorio Ruggero Zilioli | ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia | Recruiting | Alessandria | Italy |
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| up to 28 months |
| Overall Survival (OS) | Overall Survival (OS) at + 12 months after CAR-T therapy | 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 | 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 | up to 28 months |
| AOU Ospedali Riuniti - Clinica di Ematologia | Recruiting | Ancona | Italy |
|
| Azienda Ospedaliera S .Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico | Recruiting | Avellino | Italy |
|
| IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati | Recruiting | Aviano | Italy |
|
| ASST Spedali Civili di Brescia - S.C. Ematologia | Recruiting | Brescia | Italy |
|
| Ospedale di Castelfranco Veneto - Oncoematologia IOV | Recruiting | Castelfranco Veneto | Italy |
|
| Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia | Recruiting | Florence | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia | Recruiting | Milan | Italy |
|
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia | Recruiting | Milan | Italy |
|
| Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia | Recruiting | Milan | Italy |
|
| A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia | Recruiting | Palermo | Italy |
|
| Ospedale S. Maria della Misericordia - Ematologia | Recruiting | Perugia | Italy |
|
| Ospedale Guglielmo da Saliceto - U.O. Ematologia | Recruiting | Piacenza | Italy |
|
| AOU Pisana - U.O. Ematologia | Not yet recruiting | Pisa | Italy |
|
| Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia | Recruiting | Reggio Emilia | Italy |
|
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia | Recruiting | Roma | Italy |
|
| Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione | Recruiting | Roma | Italy |
|
| A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia | Recruiting | Torino | Italy |
|
| Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Clinica di Ematologia | Recruiting | Udine | Italy |
|
| AOU Integrata di Verona - U.O. Ematologia | Recruiting | Verona | Italy |
|
| ULSS 8 Berica - Ospedale S. Bortolo - Ematologia | Recruiting | Vicenza | Italy |
|
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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