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    Summary
    EudraCT Number:2017-000106-38
    Sponsor's Protocol Code Number:JCAR017-BCM-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2021-01-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-000106-38
    A.3Full title of the trial
    A Phase 2, single-arm, multi-cohort, multi-center trial to determine the efficacy and safety of JCAR017 in adult subjects with aggressive B-cell Non-Hodgkin Lymphoma
    Studio di fase 2, multicentrico, a singolo braccio e coorti multiple, per determinare l¿efficacia e la sicurezza di JCAR017 in soggetti adulti con Linfoma Non-Hodgkin a cellule B aggressivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of JCAR017, a CAR-T cell therapy, in adults with aggressive B-Cell Non-Hodgkin Lymphoma
    Studio per determinare l¿efficacia e la sicurezza di JCAR017, una terapia con cellule CAR-T, in adulti con Linfoma Non- Hodgkin a cellule B aggressivo
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    n.a.
    A.4.1Sponsor's protocol code numberJCAR017-BCM-001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN12345678
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT12345678
    A.5.3WHO Universal Trial Reference Number (UTRN)U1234-1234-1234
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCELGENE CORPORATION
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225, Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018882601599
    B.5.5Fax number0019132660394
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1890 EU/3/18/2018 EU/3/18/2099
    D.3 Description of the IMP
    D.3.1Product nameJCAR017
    D.3.2Product code JCAR017
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCellule T autologhe CD4+ e CD8+ che esprimono un recettore chimerico di antigene (CAR) specifico per CD19
    D.3.9.2Current sponsor codeJCAR017
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Aggressive B-cell Non Hodgkin Lymphoma (B-NHL)
    Linfoma non Hodgkin a cellule B aggressivo (B-NHL)
    E.1.1.1Medical condition in easily understood language
    A cancer of B-cells, a type of white blood cell responsible for producing Antibodies
    Un cancro delle cellule B, un tipo di globuli bianchi responsabili della produzione di anticorpi
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10029593
    E.1.2Term Non-Hodgkin's lymphoma NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the efficacy, defined as overall response rate (ORR), of JCAR017 in subjects with aggressive B-cell non-Hodgkin lymphoma.
    L'obiettivo principale dello studio è determinare l'efficacia, definita come tasso di risposta complessiva (ORR, overall response rate) di JCAR017 in soggetti con linfoma non Hodgkin a cellule B aggressivo.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and feasibility of administering JCAR017
    - To evaluate ORR of JCAR017 in underlying chronic lymphocytic leukemia (CLL) in subjects with Richter's transformation (Cohort 6)
    - To evaluate other measures of efficacy of JCAR017 (e.g., complete response rate [CRR], event-free survival [EFS], progression-free survival [PFS], overall survival [OS], duration of response [DOR])
    - To characterize the pharmacokinetic (PK) profile of JCAR017 in the peripheral blood measured using qPCR detection for the JCAR017 vector sequence
    - Describe changes in health-related quality of life using the European Organisation for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30), the European Quality of Life-5 Dimensions health state classifier to 5 Levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) "Additional concerns" scale
    - Valutare sicurezza e fattibilità della somministr.di JCAR017
    - Valutare la ORR di JCAR017 nella leucemia linfatica cronica(LLC)sottostante nei soggetti con trasformaz.di Richter(Coorte 6)
    - Valutare altre misure di efficacia di JCAR017(ad es.tasso di risposta completa[CRR],sopravviv.libera da evento[EFS],sopravviv.libera da progressione (PFS],sopravviv.globale[OS],durata della risposta (DOR])
    - Caratterizzare il profilo farmacocinetico (PK) di JCAR017 nel sangue periferico misurato utilizzando il rilevamento qPCR per la sequenza del vettore JCAR017
    - Descrivere i cambiamenti della qualit¿ della vita correlata alla salute utilizzando questionario C30 sulla qualità della vita della European Organisation for Research and Treatment of Cancer(EORTC QLQ-C30),questionario europeo sulla qualit¿ della vita a 5 dimens.per la classificaz.dello stato di salute in 5 livelli(EQ-5D-5L)e la Valutaz.funz.della terapia antitumorale-Linfoma(FACT-Lym)nella scala Additional Concerns
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is = 18 years of age at the time of signing the informed consent form (ICF).
    2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
    3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
    4. Investigator considers the subject is appropriate for adoptive T cell therapy.
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Cohort 1, 4, 5 or 6). Subjects not eligible for transplant (TNE) with ECOG performance status 0, 1 or 2 may be enrolled in Cohort 2 or 3 only, if they meet all other inclusion/exclusion criteria.
    6. Subjects with one of the following:
    • Cohort 1: Subjects with DLBCL NOS (de novo or tFL), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B per WHO 2016 classification (Swerdlow, 2016), after >= 2 lines of therapy*, including an anthracycline and rituximab (or other CD20-targeted agent).
    • Cohort 2: Transplant not eligible subjects with DLBCL NOS (de novo or tFL), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B per WHO 2016 classification (Swerdlow, 2016), who failed first line therapy including an anthracycline and rituximab (or other CD-20-targeted agent).
    - Transplant not eligible subjects will include those who are deemed ineligible for high-dose chemotherapy and HSCT due to age, performance status or comorbidity. At the very least, subjects have to meet one of the following criteria:
    age = 70 years, ECOG performance status = 2, impaired pulmonary function (DLCO = 60%), impaired cardiac function (LVEF < 50%), impaired renal function (CrCl < 60 mL/min) or impaired hepatic function (AST/ALT > 2x ULN, bilirubin > 2 mg/dL or cirrhosis Child-Pugh B or C).
    - Subjects must fulfil all other in- and exclusion criteria
    • Cohort 3: (Japan only): Subjects meeting eligibility criteria for either Cohort 1 or 2.
    • Cohort 4: Subjects with high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) who failed first line therapy*. Subjects may be screened at time of initial diagnosis and leukapheresis may be performed prior to initiation of first line therapy.
    • Cohort 5: Subjects with PCNSL after = 1 line of therapy, including high-dose methotrexate.
    • Cohort 6: Subjects with Richter's transformation after = 1 line of therapy for Richter's transformation.
    *For subjects with transformed disease, the subject should have had at least 2 lines of systemic therapy for his/her transformed disease (i.e. DLBCL) for Cohort 1 and 1 line for Cohort 2 to be eligible. Lines of therapy do not include those given for a previously indolent condition (i.e. follicular lymphoma). Subjects do NOT have to have anthracycline for their DLBCL if received for indolent disease.
    Note: Subjects with secondary CNS lymphoma involvement may enroll in Cohorts 1 to 4 and 6; subjects with PCNSL are eligible for Cohort 5.
    Subject selection must consider clinical risk factors for severe adverse events (AEs) and alternative treatment options. Subjects should only be enrolled if the Investigator considers the potential benefit outweighs the risk for the subject.
    7. Histological confirmation of diagnosis at last relapse. Enough tumor material must be available for central confirmation of diagnosis, otherwise a new tumor biopsy is mandated.
    Note: If the subject did not experience CR since last biopsy, the most recent biopsy will be considered adequate to participate in the trial. For subjects with PCNSL, at a minimum, corresponding pathology report is required if archival tumor material is not available and repeated biopsy not feasible.

    Please refer to protocol section 4.2 for inclusion criteria 08 -14
    1. Il sogg ha almeno 18 anni di età al momento della firma dell'ICF.
    2. Il sogg deve capire e firmare volontariam.un ICF prima che siano condotte valutazioni/procedure connesse allo studio.
    3. Il sogg è disposto ed in grado di attenersi al progr.di visite dello studio e agli altri requisiti del protocollo.
    4. Lo sperimentatore considera il sogg appropriato per il trasferim.adottivo di cellule T.
    5. Performance status ECOG tra 0 e 1 (Coorte 1,4,5 o 6).I sogg non idonei a trapianti (TNE) con ECOG 0,1 o 2 possono essere arruol solo nella Coorte 2 o 3, se soddisfano tutti gli altri crit d incl/escl.
    6. Sogg con 1 dei seguenti:
    • Coorte 1:Soggetti con DLBCL NAS(de novo o tFL), linfoma a cellule B di grado elevato con riarrangiam.di MYC e BCL2 e/o BCL6 con istologia DLBCL(DHL/THL)e FL3B secondo la classificaz.dell’OMS del 2016(Swerdlow, 2016), dopo >= 2 linee di terapia*, comprensive di un’antraciclina e rituximab(o altro agente mirato sul CD20)
    • Coorte 2:Sogg non idonei al trapianto con DLBCL NAS(de novo o tFL),linfoma a cellule B di grado elevato con riarrangiam.di MYC e BCL2 e/o BCL6 con istologia DLBCL(DHL/THL)e FL3B secondo la classificazione dell’OMS del 2016 (Swerdlow, 2016),che non hanno risposto alla terapia di prima linea, comprens.di un’antraciclina e rituximab(o altro agente mirato sul CD20).
    - Soggetti non idonei al trapianto comprenderanno quelli ritenuti non idonei alla chemioterapia ad alte dosi e al HSCT a causa dell’età,performance status o comorbilità.I soggetti devono soddisfare almeno uno dei seguenti criteri:
    - età = 70 anni, performance status ECOG >= 2, funz.polmonare compromessa(DLCO = 60%),funz.cardiaca compromessa (LVEF < 50%), funz.renale compromessa(CrCl < 60 mL/min)o funz.epatica compromessa (AST/ALT > 2x ULN, bilirubina > 2 mg/dL o cirrosi di grado B o C secondo Child-Pugh).
    - I sogg devono soddisfare tutti gli altri criteri di inclusione ed esclusione
    • Coorte 3(Solo Giappone):Sogg che soddisfano i criteri di idoneità per la Coorte 1 o 2.
    • Coorte 4:Sogg con linfoma a cellule B di grado elevato con riarrangiam.di MYC e BCL2 e/o BCL6 con istologia DLBCL(DHL/THL)che non abbiano risposto alla terapia di prima linea*.I sogg possono essere sottoposti allo screening al momento della diagnosi iniziale ed è possibile eseguire la leucaferesi prima dell'inizio della terapia di prima linea.
    • Coorte 5:Soggetti con PCNSL dopo >= 1 linee di terapia,comprens.di metotrexato ad alto dosaggio.
    • Coorte 6:Sogg con trasformaz.di Richter dopo >= 1 linea di terapia per la trasformaz.di Richter.
    *Per i sogg con malattia trasformata, per essere eleggibili, i sogg devono aver avuto almeno 2linee di terapia sistemica per la malattia trasformata (es. DLBCL) per la Coorte1 e 1 linea per la Coorte2. Le linee di terapia non includono quelle date per una condiz precedentemente indolente (es. linfoma follicolare). I sogg NON devono avere ricevuto antracicline per il loro DLBCL se ricevuto per malattia indolente.
    Nota: i sogg con coinvolgimento second del linfoma del SNC possono essere arruolati nelle Coorti da 1 a 4 e 6; i sogg con PCNSL sono idonei per la Coorte 5.
    La selez dei sogg deve considerare i fattori di rischio clinici per eventi avversi gravi (AE) e opzioni di trattam alternative. I sogg dovrebbero essere arruolati solo se lo sperimentatore ritiene che il potenziale beneficio superi il rischio per il sogg.
    7. Conferma istologica della diagnosi all’ultima recidiva.Deve essere disponibile materiale tumorale sufficiente per la conferma centrale della diagnosi, altrimenti è necessaria una nuova biopsia tumorale. NOTA:Se il soggetto non ha avuto esperienza di CR dall'ultima biopsia, la biopsia più recente sarà considerata adeguata per partecipare allo studio. Per i soggetti con PCNSL, è necessario almeno un referto patologico corrispondente se il materiale del tumore archiviato non è disponibile e non è fattibile ripetere la biopsia.

    Si prega di fare riferimento alla Sezione 4.2 del protocollo per crit. incl. 08 -14
    E.4Principal exclusion criteria
    1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
    2. Subject has any condition including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if participating in the study.
    3. Subject has any condition that confounds the ability to interpret data from the study.
    4. Subjects with T cell rich/histiocyte rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV positive DLBCL of the elderly and Burkitt lymphoma.
    5. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been in remission for 2 years with the exception of the following non-invasive malignancies:
    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative
    •Other completely resected stage 1 solid tumor with low risk for recurrence
    6. Treatment with any prior gene therapy product.
    7. Subjects who have received previous CD19-targeted therapy.
    8. Previous history of or active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
    9. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment at the time of leukapheresis or JCAR017 infusion.
    10. Presence of acute or chronic graft-versus-host disease (GVHD).
    11. Active autoimmune disease requiring immunosuppressive therapy.
    12. History of any one of the following cardiovascular conditions within the past 6 months:
    • Heart failure class III or IV as defined by the New York Heart Association (NYHA)
    • Cardiac angioplasty or stenting
    • Myocardial infarction
    • Unstable angina
    • Other clinically significant cardiac disease
    13. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
    14. Pregnant or nursing women.
    15. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis

    Please refer to protocol section 4.3 for inclusion criteria 16-18
    1. Il soggetto ha una qualsiasi patologia medica significativa, anomalia di test di laboratorio o malattia psichiatrica che gli/le impedirebbe di partecipare allo studio.
    2. Il soggetto presenta qualsiasi condizione, compresa la presenza di anomalie dei test di laboratorio, che lo/la esporrebbe a un rischio inaccettabile nel caso in cui partecipasse allo studio.
    3. Il soggetto presenta qualsiasi condizione che confonda la capacità di interpretare i dati provenienti dallo studio.
    4. Soggetti con linfoma a grandi cellule B ricco di cellule T/ ricco di istiociti (THRBCL), linfoma primario percutaneo a grandi cellule B, linfoma primario mediastinico a cellule B (PMBCL), DLBCL positivo per EBV dell’anziano e linfoma di Burkitt.
    5. Soggetti con storia pregressa di neoplasie maligne, diverse da R/R NHL aggressivo, a meno che il soggetto non sia stato in remissione per 2 anni, ad eccezione delle seguenti neoplasie non invasive:
    • Carcinoma basocellulare della pelle
    • Carcinoma della pelle a cellule squamose
    • Carcinoma in situ della cervice
    • Carcinoma in situ del seno
    • Rilevazione istologica incidentale del carcinoma della prostata (T1a o T1b usando il sistema di stadiazione clinica TNM [tumore, nodi, metastasi]) o cancro prostata che è curativo
    • Altro tumore solido allo stadio 1 completamente resecato a basso rischio per ricorrenza
    6. Trattamento con qualsiasi terapia genica precedente.
    7. Soggetti che hanno ricevuto precedente terapia anti CD19.
    8. Anamnesi precedente di epatite B, epatite C attive, o infezione da virus immunodeficienza umana (HIV).
    9. Soggetti con infezioni sistemiche non controllate fungine, batteriche, virali o di altro tipo (compresa tubercolosi) nonostante antibiotici appropriati o altro trattamento al momento della leucoferesi o dell’infusione di JCAR017.
    10. Presenza di malattia del trapianto contro l’ospite (GvHD) acuta o cronica.
    11. Malattia autoimmune attiva che richieda terapia immunosoppressiva.
    12. Anamnesi di una qualsiasi delle seguenti condizioni cardiovascolari negli ultimi 6 mesi:
    • Insufficienza cardiaca di classe III o IV della New York Heart Association (NYHA)
    • Angioplastica cardiaca o stent
    • Infarto miocardico
    • Angina instabile
    • Altra malattia cardiaca clinicamente significativa
    13. Anamnesi o presenza di patologia del SNC clinicamente rilevante come epilessia, convulsioni, afasia, ictus, edema cerebrale, gravi lesioni cerebrali, demenza, malattia di Parkinson, malattia cerebellare, sindrome cerebrale organica o psicosi.
    14. Donne in gravidanza o che allattano.
    15. Trattamento con alemtuzumab entro 6 mesi dalla leucaferesi o trattamento con fludarabina o cladribina entro 3 mesi dalla leucaferesi

    Per i criteri di esclusione 16-18, fare riferimento alla sezione 4.3 del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    - Non-Hodgkin lymphoma (NHL; including secondary central nervous system [CNS] involvement): Overall Response Rate (ORR)
    Cohorts 1, 2, 3, 4 and 6
    - Relapsed/refractory (r/r) primary central nervous system lymphoma (PCNSL): ORR
    Cohort 5
    -Linfoma non Hodgkin (NHL, compresi coinvolgimento secondario del sistema nervoso centrale [SNC]): Tasso Di Risposta Complessivo (ORR)
    Coorti 1, 2, 3, 4 e 6
    -Linfoma primario del sistema nervoso centrale (PCNSL) recidivo/refrattario (r/r): ORR
    Coorte 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 2 years after JCAR017 infusion
    Fino a 2 anni dopo l’infusione di JCAR017
    E.5.2Secondary end point(s)
    - Safety
    - Underlying chronic lymphocytic leukemia (CLL) in subjects with Richter¿s transformation: ORR Cohort 6
    - Complete response rate (CRR)
    - Event-free survival (EFS)
    - Progression-free survival (PFS)
    - Overall survival (OS)
    - Duration of response (DOR)
    - PK
    - Patient-Reported Outcomes
    - Sicurezza
    - Leucemia linfatica cronica (LLC) sottostante nei soggetti con trasformazione di Richter: ORR Coorte 6
    - Tasso di risposta completa (CRR)
    - Sopravvivenza libera da evento (EFS)
    - Sopravvivenza libera da progressione (PFS)
    - Sopravvivenza globale (OS)
    - Durata della risposta (DoR)
    - PK
    - Esiti segnalati dal paziente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 2 years after JCAR017 infusion
    For overall survival (OS) - up to last subject last visit
    Fino a 2 anni dopo l'infusione di JCAR017
    Per la sopravvivenza globale (OS) - fino all'ultima visita dell'ultimo paziente
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    Austria
    Belgium
    Finland
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    The End of Trial is defined as either the date of the last visit of the last subject completing the post-treatment follow-up of this study or the date when the last subject enters the LTFU study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    La fine dello studio ¿ definita come la data dell¿ultima visita dell¿ultimo soggetto che completa il follow-up post-trattamento dello studio o la data in cui l'ultimo soggetto accede allo studio di LTFU, oppure la data di ricezione dell¿ultimo data point dall¿ultimo soggetto, necessario per l¿analisi primaria, secondaria e/o esplorativa, come specificato a priori nel protocollo (l'ultima tra le date suddette).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 124
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Because this protocol involves gene transfer, long-term follow-up for lentiviral vector safety, disease status, and survival will continue on this protocol until 24 months after last infusion of JCAR017, regardless of disease status, and rolled over to a separate LTFU protocol thereafter for up to 15 years after JCAR017 infusion.
    Poich¿ questo protocollo comprende il trasferimento genico, il follow-up a lungo termine per la sicurezza del vettore lentivirale, dello stato della malattia e della sopravvivenza continueranno su questo protocollo fino a 24 mesi dopo l¿ultima infusione di JCAR017, indipendentemente dallo stato della malattia, e sar¿ poi trasferito ad un protocollo LTFU separato fino a 15 anni dopo l¿infusione di JCAR017.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-07
    P. End of Trial
    P.End of Trial StatusRestarted
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