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    Summary
    EudraCT Number:2017-002949-30
    Sponsor's Protocol Code Number:ATA129-EBV-302
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 number2017-002949-30
    A.3Full title of the trial
    Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)
    Studio multicentrico, in aperto, di fase 3 su tabelecleucel per soggetti sottoposti a trapianto di organo solido o trapianto allogenico di cellule ematopoietiche con malattia linfoproliferativa post-trapianto associata al virus di Epstein-Barr dopo fallimento della terapia con rituximab o rituximab e chemioterapia (studio ALLELE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for subjects after organ or cell transplantation after failure of prior treatment
    Uno studio per soggetti sottoposti a trapianto di organo o cellulare dopo fallimento della precedente terapia
    A.3.2Name or abbreviated title of the trial where available
    ALLELE study
    Studio ALLELE
    A.4.1Sponsor's protocol code numberATA129-EBV-302
    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 SponsorAtara Biotherapeutics Inc.
    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 supportAtara Biotherapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAtara Biotherapeutics, Inc.
    B.5.2Functional name of contact pointLan T Hoang
    B.5.3 Address:
    B.5.3.1Street Address2380 Conejo Spectrum Street, Suite 200
    B.5.3.2Town/ cityThousands Oaks
    B.5.3.3Post code91320
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018053092965
    B.5.5Fax number0018882978163
    B.5.6E-maillhoang@atarabio.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/3/16/1627
    D.3 Description of the IMP
    D.3.1Product nametabelecleucel
    D.3.2Product code [ATA129]
    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 INNTABELECLEUCEL
    D.3.9.2Current sponsor codeATA129
    D.3.9.4EV Substance CodeSUB194902
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000000
    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 Yes
    D.3.11.3.2Gene therapy medical product No
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberSomatic cell therapy medicinal product, 30 May 2016 Doc. Ref. EMA/CAT/327742/2016
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    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
    Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease
    Malattia linfoproliferativa post-trapianto associata al visrus Epstein Barr
    E.1.1.1Medical condition in easily understood language
    Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after failure of prior treatment
    Malattia linfoproliferativa post-trapianto associata al visrus Epstein Barr dopo fallimento di un precedente trattamento
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10068349
    E.1.2Term Epstein-Barr virus associated lymphoproliferative disorder
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10075146
    E.1.2Term Post transplant Epstein-Barr virus associated lymphoproliferative disorder
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To determine the clinical benefit of tabelecleucel (ATA129; allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes [EBV-CTLs]) in subjects with EBV-associated post-transplant lymphoproliferative disease (EBV+ PTLD) following (1) solid organ transplant (SOT) and after failure of rituximab (Subgroup A) and rituximab plus chemotherapy (Subgroup B) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab, as measured by the objective response rate (ORR).
    - determinare il beneficio clinico di tabelecleucel (ATA129; linfociti T citotossici allogenici specifici per il virus di Epstein-Barr [EBV-CTL]) in soggetti con malattia linfoproliferativa post-trapianto associata al virus di Epstein-Barr (PTLD EBV+) in seguito (1) a trapianto di organo solido (SOT) e dopo fallimento della terapia con rituximab (Sottogruppo A) e rituximab più chemioterapia (Sottogruppo B) oppure (2) trapianto allogenico di cellule emopoietiche (HCT) dopo il fallimento della terapia con rituximab, misurato in base al tasso di risposta obiettiva (objective response rate, ORR).
    E.2.2Secondary objectives of the trial
    - To evaluate duration of response (DOR) in the SOT and HCT cohorts separately
    - To evaluate ORR and DOR in the SOT and HCT cohorts combined
    - To evaluate rates of complete response (CR) and partial response (PR)
    - To evaluate time to response and time to best response
    - To evaluate overall survival (OS)
    - To evaluate graft status (SOT subjects only)
    - To characterize the safety profile of tabelecleucel in this subject population
    • Valutare la durata della risposta (duration of response, DOR) nelle coorti SOT e HCT separatamente
    • Valutare l’ORR e la DOR nelle coorti SOT e HCT combinate
    • Valutare i tassi di risposta completa (CR) e risposta parziale (PR)
    • Valutare il tempo alla risposta e il tempo alla risposta migliore
    • Valutare la sopravvivenza complessiva (overall survival, OS)
    • Valutare lo stato del trapianto (solo per i soggetti sottoposti a SOT)
    • Caratterizzare il profilo di sicurezza di tabelecleucel in questa popolazione di soggetti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort); or prior allogeneic HCT (HCT cohort).
    2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD.
    3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.
    4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score = 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For subjects with treated central nervous system (CNS) disease, head diagnostic CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.
    5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (SOT subgroup A or HCT cohort) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (SOT subgroup B) for treatment of PTLD. Treatment failure is defined based on rituximab response as follows:
    a.Radiographic disease progression per Lugano Classification following a minimum cumulative dose of 1125 mg/m2 rituximab (typically, 3 weekly doses of 375 mg/m2), or
    b. Failure to achieve CR or PR, defined by Lugano radiographic criteria, after a minimum cumulative dose of 1500 mg/m2 rituximab (typically, 4 weekly doses of 375 mg/m2), or
    c. Relapse/progression of PTLD after a response to rituximab (SOT subgroup A or HCT cohort) or rituximab plus chemotherapy (SOT subgroup B), defined as radiographic and/or biopsy evidence of relapse/progression consistent with PTLD; if the underlying disease for which the subject underwent allogeneic HCT (HCT cohort) was lymphoma, biopsy confirmation of relapsed EBV+ PTLD is required.
    6. Males and females of any age.
    7. Eastern Cooperative Oncology Group performance status = 3 for subjects aged > 16 years; Lansky score = 20 for subjects from birth to 16 years.
    8. For HCT cohort only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission.
    9. Adequate organ function:
    a. Absolute neutrophil count = 1000/µL (SOT cohort) or = 500/µL (HCT cohort), with or without cytokine support
    b. Platelet count = 50,000/µL, with or without transfusion or cytokine support. For HCT cohort, platelet count < 50,000/µL but = 20,000/µL,with or without transfusion support, is permissible if the subject has not had grade = 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) each < 5 × the upper limit of normal (ULN); however, ALT, AST, and TBILI each = 10 × ULN is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction (eg, elevated prothrombin time due to liver dysfunction, signs/symptoms of liver dysfunction such as asterixis, or similar).
    10. Subject or subject's representative is willing and able to provide written informed consent.
    1. Precedente SOT di rene, fegato, cuore, polmone, pancreas, intestino tenue o qualsiasi combinazione di questi (coorte SOT); o precedente HCT allogenico (coorte HCT)
    2. Una diagnosi di PTLD EBV+ comprovata da biopsia e valutata a livello locale
    3. Disponibilità di tabelecleucel parzialmente HLA-compatibile e ristretto confermata dallo sponsor
    4. Malattia sistemica avida di 18F-desossiglucosio (FDG) (punteggio di Deauville =3) utilizzando i criteri di risposta della Classificazione di Lugano, misurabile mediante tomografia ad emissione di positroni (PET)-tomografia computerizzata (TC) diagnostica, tranne se controindicato o imposto dalla prassi locale, nel qual caso può essere eseguita una risonanza magnetica (RM). Per i soggetti con malattia a carico del sistema nervoso centrale (SNC) trattata, sarà richiesta una TC diagnostica della testa e/o una RM cerebrale/spinale, se clinicamente appropriato, al fine di monitorare la risposta della malattia del SNC secondo i criteri di risposta della Classificazione di Lugano.
    5. Fallimento della terapia con rituximab o di un biosimilare intercambiabile in monoterapia disponibile in commercio (Sottogruppo SOT A o coorte HCT) o rituximab più qualsiasi regime chemioterapico concomitante o somministrato in sequenza (Sottogruppo SOT B) per il trattamento della PTLD. Il fallimento della terapia è definito in base alla risposta a rituximab come segue:
    a. progressione radiografica della malattia in base alla Classificazione di Lugano a seguito di una dose minima cumulativa di 1.125 mg/m2 di rituximab (solitamente, 3 dosi settimanali di 375 mg/m2) o
    b. mancato raggiungimento di una CR o PR, definita secondo i criteri radiografici di Lugano, dopo una dose minima cumulativa di 1.500 mg/m2 di rituximab (solitamente, 4 dosi settimanali di 375 mg/m2) o
    c. recidiva/progressione della PTLD dopo una risposta a rituximab (Sottogruppo SOT A o coorte HCT) o rituximab più chemioterapia (Sottogruppo SOT B), definita come evidenza radiografica e/o bioptica di recidiva/progressione coerente con PTLD; se la malattia sottostante per cui il soggetto è stato sottoposto a HCT allogenico (coorte HCT) era il linfoma, è necessaria la conferma bioptica della recidiva di PTLD EBV+
    6. Soggetti ambosesso di qualsiasi età
    7. Stato di validità dell’Eastern Cooperative Oncology Group (gruppo orientale cooperativo di oncologia) = 3 per i soggetti di età >16 anni; punteggio di Lansky =20 per i soggetti dalla nascita a 16 anni
    8. Solo per la coorte HCT: se è stato eseguito un HCT allogenico come trattamento per un tumore maligno linfoide o mieloide acuto, la malattia primaria sottostante per la quale il soggetto si è sottoposto al trapianto deve essere in remissione morfologica
    9. Adeguata funzione d’organo
    a. Conta assoluta dei neutrofili =1.000/µl (coorte SOT) o = 500/µl (coorte HCT), con o senza supporto citochinico
    b. Conta piastrinica =50,000/µl, con o senza supporto trasfusionale o citochinico. Per la coorte HCT, è consentita una conta piastrinica <50,000/µl ma =20,000/µl, con o senza supporto trasfusionale purché il soggetto non abbia manifestato un’emorragia di grado =2 nelle precedenti 4 settimane (laddove l’emorragia venga classificata secondo i Criteri di terminologia comuni per gli eventi avversi [CTCAE], versione 5.0)
    c. Alanina aminotransferasi (ALT), aspartato aminotransferasi (AST) e bilirubina totale (TBILI) ciascuna <5 × il limite superiore della norma (ULN); tuttavia, sono accettabili valori di ALT, AST e TBILI =10 × ULN ciascuno se l’aumento è considerato dallo sperimentatore imputabile al coinvolgimento del fegato da parte dell’EBV e/o della PTLD, purché non vi sia alcuna evidenza nota di disfunzione epatica significativa (ad es., tempo di protrombina elevato a causa di disfunzione epatica, segni/sintomi di disfunzione epatica come asterissi o simile).
    10. Disponibilità e capacità del soggetto o del suo rappresentante di fornire il consenso informato scritto
    E.4Principal exclusion criteria
    1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T-cell lymphoma.
    2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis.
    3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment.
    NOTE: Subjects with previously treated CNS PTLD may enroll if CNSdirected therapy is complete.
    4. Suspected or confirmed grade = 2 graft-versus-host disease per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment.
    5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab,pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment.
    6. For HCT cohort only: Active adenovirus viremia.
    7. Need for vasopressor or ventilatory support.
    8. Antithymocyte globulin or similar anti-T-cell antibody therapy = 4 weeks prior to enrollment.
    9. Treatment with EBV-CTLs or chimeric antigen receptor (CAR) T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts); or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only).
    10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception.
    11. Inability to comply with study-related procedures
    1. Linfoma di Burkitt, linfoma di Hodgkin classico o qualsiasi linfoma a cellule T
    2. Dose giornaliera di steroidi >0,5 mg/kg di prednisone o glucocorticoide equivalente, terapia in corso con metotrexato o fotoferesi extracorporea
    3. PTLD del SNC non trattata o PTLD del SNC per la quale il soggetto è in trattamento attivo con una chemioterapia (sistemica o intratecale) o radioterapia mirata al SNC al momento dell’arruolamento. NOTA: i soggetti con PTLD del SNC precedentemente trattata possono essere arruolati purché sia stata completata la terapia mirata al SNC.
    4. Malattia del trapianto contro l’ospite di grado =2 sospetta o confermata secondo il sistema di classificazione consensuale del Centro per la ricerca internazionale sui trapianti di sangue e midollo osseo (CIBMTR) al momento dell’arruolamento
    5. Utilizzo in corso o recente di un agente inibitore del checkpoint (ad es., ipilimumab, pembrolizumab, nivolumab) entro 3 emivite del farmaco dalla dose più recente all’arruolamento
    6. Solo per la coorte HCT: viremia adenovirale attiva
    7. Necessità di supporto vasopressorio o ventilatorio
    8. Globulina antitimocita o analoga terapia anticorpale anti-cellule T =4 settimane prima dell’arruolamento
    9. Trattamento con EBV-CTL o cellule T esprimenti il recettore antigenico chimerico (CAR) dirette contro le cellule B entro 8 settimane dall’arruolamento (coorti SOT o HCT); o infusione di linfociti da donatore non selezionati entro 8 settimane dall’arruolamento (solo coorte HCT)
    10. Donne in fase di allattamento o in stato di gravidanza o donne in età fertile oppure uomini con una partner in età fertile che non intendono utilizzare un metodo contraccettivo altamente efficace
    11. Incapacità di attenersi alle procedure correlate allo studio
    E.5 End points
    E.5.1Primary end point(s)
    The ORR (CR or PR) obtained following administration of tabelecleucel with up to 2 different HLA restrictions in the SOT or HCT cohort
    ORR (CR o PR) ottenuto dopo la somministrazione di tabelecleucel con un massimo di 2 diverse restrizioni HLA nella coorte SOT o HCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorato durante lo studio
    E.5.2Secondary end point(s)
    - DOR in SOT and HCT cohorts separately.
    - ORR and DOR in SOT and HCT cohorts combined.
    - Rates of CR and PR
    - Time to response and time to best response
    - OS
    - Rates of allograft loss/rejection episodes (for SOT cohort only): loss is defined as allograft removal, resumption of renal replacement therapy
    (kidney), initiation of a ventricular assist device (heart), need for mechanical ventilation or extracorporeal membrane oxygenation (lung), re-transplant (any), or placement on a SOT list (any); rejection episodes will be defined according to appropriate criteria for the particular organ
    transplant.
    • DOR nelle coorti SOT e HCT separatamente
    • ORR e DOR nelle coorti SOT e HCT combinate
    • Tassi di CR e PR
    • Tempo alla risposta e tempo alla risposta migliore
    • OS
    • Tassi di episodi di perdita/rigetto dell’allotrapianto (solo per la coorte SOT): la perdita è definita come rimozione dell’allotrapianto, ripresa della terapia di sostituzione renale (rene), avvio dell’uso di un dispositivo di assistenza ventricolare (cuore), necessità di ventilazione meccanica od ossigenazione a membrana extracorporea (polmoni), nuovo trapianto (qualsiasi) o inserimento in una lista di SOT (qualsiasi); gli episodi di rigetto saranno definiti in base a criteri appropriati per lo specifico organo trapiantato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorato durante lo studio
    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 No
    E.6.12Pharmacoeconomic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 EEA18
    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
    Australia
    Austria
    Belgium
    Canada
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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
    After treatment is completed or discontinued, subjects will be assessed for disease response every 3 months, up to 24 months from cycle 1 day
    1, and every 6 months thereafter up to 5 years from cycle 1 day 1 for survival status.
    Dopo la conclusione o interruzione dello studio, i soggetti verranno valutati sulla base della risposta della malattia ogni 3 mesi, fino a 24 mesi dal ciclo 1 giorno 1, e ogni 6 mesi in avanti fino a 5 anni dal ciclo 1 giorno 1 per lo stato di sopravvivenza.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 66
    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)
    none
    nessuno
    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 Decision2020-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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