E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diffuse large B-cell lymphoma |
linfoma diffuso a grandi cellule B |
|
E.1.1.1 | Medical condition in easily understood language |
Diffuse large B-cell lymphoma |
linfoma diffuso a grandi cellule B |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012818 |
E.1.2 | Term | Diffuse large B-cell lymphoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objective Response Rate |
Valutare la percentuale di risposta obiettiva (ORR) |
|
E.2.2 | Secondary objectives of the trial |
Safety Response Duration, Progression Free Survival, Overall Survival |
•Valutare l’efficacia in termini di durata della risposta (DR), sopravvivenza libera da progressione (PFS) e sopravvivenza complessiva (OS) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) based on recent (less than 3 months) or new biopsy, expressing CD19 by immunohistochemistry or flow cytometry analysis (at least or more than 30% positivity). • At least 1 and not more than 2 prior specific therapeutic regimens, one of which should have included rituximab • Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion. • Available paraffin-embedded tissue should have been collected no longer than 3 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained. • Signed written informed consent |
I 01. Diagnosi istologica del DLBCL (de novo o trasformato) sulla base di biopsia recente (risalente a non più di 3 mesi) o nuova, esprimente CD19 mediante immunoistochimica o citometria a flusso (positività > 30%). I 02. Almeno 1 e non più di 2 precedenti schemi terapeutici specifici, uno dei quali deve aver incluso rituximab I 03. Malattia recidivante dopo la terapia standard di prima linea per linfoma aggressivo – non idonea alla chemioterapia ad alte dosi con supporto di cellule staminali, oppure malattia recidivante o refrattaria dopo due linee di terapia, una delle quali potrebbe aver incluso il trapianto autologo di cellule staminali (ASCT). Si definisce malattia recidivante una progressione dopo un intervallo senza malattia di almeno 6 mesi successivamente al completamento dell’ultima terapia. Si definisce malattia refrattaria la progressione della malattia durante la terapia precedente o entro 6 mesi dal completamento di quest’ultima. I 04. Il campione disponibile di tessuto immerso in paraffina non deve essere stato raccolto più di 3 mesi prima della prima somministrazione di SAR3419. Non può essere utilizzato tessuto crioconservato. Se non è disponibile materiale d’archivio, si deve praticare un’aspirazione con ago sottile (FNA). I 05. Consenso informato scritto firmato |
|
E.4 | Principal exclusion criteria |
• Primary refractory patients • Patients with primary mediastinal DLBCL |
E 01. Pazienti refrattari primari E 02. Pazienti con DLBCL primitivo del mediastino |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Objective Response Rate |
Objective Response Rate |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Safety Response Duration, Progression Free Survival, Overall Survival |
• Sicurezza • Durata della risposta • PFS • OS |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety : treatment period Response Duration, Progression Free Survival, Overall Survival : up to 18 months after the first infusion of the last patient |
sicurezza: periodo di trattamento durata della risposta, PFS, OS: fino a 18 mesi dopo l'inclusione dell'ultimo paziente |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Israel |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
all patients, regarless they have progressed or not, will be followed ultil death or end of study to evaluate survIval for at least 18 months. |
TUTTI I PAZIENTI, INDEPENDENTEMENTE DALLA PROGRESSIONE DELLA MALATTIA, SARANNO SEGUITI FINO ALLA MORTE O ALLA FINE DELLO STUDIO PER VALUTARE LA SOPRAVVIVENZA FOR ALMENO 18 MESI. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 30 |
E.8.9.2 | In all countries concerned by the trial days | 0 |