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    Summary
    EudraCT Number:2015-003130-27
    Sponsor's Protocol Code Number:2015/2294
    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:2018-08-29
    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 number2015-003130-27
    A.3Full title of the trial
    An international multicenter phase II randomized trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy
    Studio multicentrico internazionale randomizzato di fase 2 che valuta e confronta 2 strategie di trattamento per i pazienti affetti da Neuroblastoma metastatico con risposta insufficiente alla chemioterapia di induzione
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised trial of two treatment strategies for metastatic neuroblastoma responding poorly to induction chemotherapy:
    Temozolomide and Irinotecan chemotherapy followed by either
    a)high administered activity 131I-mIBG and Topotecan, or
    b)high dose Thiotepa
    followed by Busulfan and Melphalan high dose chemotherapy
    Studio multicentrico internazionale randomizzato di fase 2 che valuta e confronta 2 strategie di trattamento per i pazienti affetti da Neuroblastoma metastatico con risposta insufficiente alla chemioterapia di induzione
    A.3.2Name or abbreviated title of the trial where available
    VERITAS
    VERITAS
    A.4.1Sponsor's protocol code number2015/2294
    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 SponsorGustave Roussy
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointSponsor CRA
    B.5.3 Address:
    B.5.3.1Street Address114, rue Edouard Vaillant
    B.5.3.2Town/ cityvillejuif
    B.5.3.3Post code94800
    B.5.3.4CountryFrance
    B.5.6E-mailjonathan.rubino@gustaveroussy.fr
    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 Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemeta-iodobenzylguanidine(131I)
    D.3.4Pharmaceutical form Solution for infusion
    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 INNmeta-iodobenzylguanidine(131I)
    D.3.9.3Other descriptive nameIOBENGUANE 131I INJECTION FOR THERAPEUTIC USE
    D.3.9.4EV Substance CodeSUB127284
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number185 to 740
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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.IMP: 2
    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 Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTopotecan
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNTopotecan
    D.3.9.1CAS number 119413-54-6
    D.3.9.3Other descriptive nameTOPOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 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 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.IMP: 3
    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 Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameThiotepa
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNTHIOTEPA
    D.3.9.1CAS number 52-24-4
    D.3.9.4EV Substance CodeSUB10985MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    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 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 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
    Very High Risk neuroblastoma
    Bambini e adolescenti con neuroblastoma ad altissimo rischio
    E.1.1.1Medical condition in easily understood language
    Neuroblastoma
    Neuroblastoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008126
    E.1.2Term Cerebral neuroblastoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.
    Valutare l’efficacia di due tipi di strategia di consolidamento intensificata in pazienti con neuroblastoma ad altissimo rischio (VHR-NBL) in termini di risultati di Sopravvivenza libera da progressione (PFS) dalla data della randomizzazione.
    E.2.2Secondary objectives of the trial
    •To estimate and compare the overall survival (OS) of patients treated in the two treatment strategies
    •To evaluate and compare the safety of the two treatment strategies in terms of toxic death and non-fatal toxicities rates.
    •To estimate and compare the disease response after BuMel and at the end of treatment of the two treatment strategies
    •To evaluate the between-treatment differences in Quality adjusted Time WIthout Symptoms and Toxicity (Q-TWiST approach)
    •To evaluate the feasibility and document the logistical issues raised by 131I-mIBG and topotecan therapy in a multicenter setting
    •To estimate and compare the Event-Free Survival of the two treatment strategies from the start of the intensified consolidation chemotherapy
    •To estimate and compare the Event-Free Survival of the two treatment strategies from the date of the neuroblastoma diagnosis

    •Valutare e comparare la sopravvivenza globale (OS) dei pazienti trattati con le due strategie
    •Valutare e comparare la sicurezza delle due strategie di trattamento in termini di percentuale tossicità letale e tossicità non letali
    •Valutare e stimare la risposta di malattia dopo trattamento con busulfano e melphalan con entrambe le strategie terapeutiche
    •Valutare le differenze tra i trattamenti in termini di Quality adjusted Time Without Symptoms and Toxicity (Q-TWiST approach)
    •Valutare la fattibilità e documentare gli aspetti logistici legati alla somministrazione di radioterapia metabolica e chemioterapia concomitante in un setting multicentrico
    •Valutazione della combinazione di 131I-mIBG e topotecan in un setting multicentrico
    •Valutare e comparare la sopravvivenza libera da eventi delle due strategie di trattamento dall’inizio della terapia di consolidamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 - Metastatic neuroblastoma (NBL)
    2 - Patient previously treated within the ongoing High Risk Neuroblastoma SIOPEN study
    3 - mIBG scintigraphy positive at diagnosis and after induction chemotherapy (pre BuMel evaluation).
    4 - Metastatic response after induction chemotherapy lower than the ongoing High Risk Neuroblastoma SIOPEN trial criteria to be eligible for High Dose Chemotherapy (metastatic response worse than partial response (< PR) or SIOPEN score ≥ 3)
    5 - Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on study drug and for one year after stopping the study drug.
    6 -Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
    7 - Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
    1.Neuroblastoma metastatico
    2.Pazienti in trattamento secondo il protocollo High Risk Neuroblastoma SIOPEN study
    3.Scintigrafia mIBG positiva alla diagnosi e dopo la chemioterapia di induzione
    4.Risposta metastatica dopo la chemioterapia di induzione minore rispetto ai criteri del protocollo High Risk Neuroblastoma SIOPEN trial per essere eligibile alla chemioterapia mieloablativa con busulfano + melphalan (cioè risposta metastatica inferiore a Remissione Parziale, o score scintigrafico SIOPEN score ≥ 3)
    5.Le femmine in età fertile devono avere un test di gravidanza negativo nella settimana precedente la inclusione nel protocollo. I partner sessualmente attivi devono accettare di utilizzare metodi contraccettivi appropriati ed accettabili durante la fase dello studio e per 1 anno dopo la conclusione del trattamento. I metodi appropriati ed accettabili sono indicati nelle CTFG Guidelines “Recommendations related to contraception and pregnancy testing in clinical trials”. Le femmine che sono in fase di allattamento devono accettare di interrompere l’allattamento.
    6.Consenso informato del paziente se maggiorenne, altrimenti consenso informato dei genitori/tutore legale. Assenso del paziente minorenne in accordo con le regole locali, regionali o nazionali prima delle procedure di screening
    7.Paziente affiliato ad un regime di previdenza sociale o beneficiario dello stesso secondo i requisiti locali.
    E.4Principal exclusion criteria
    1 - Parenchymal brain metastasis (even one)
    2 - Progressive disease at study entry
    3 - Previous high-dose therapy and PBSCT
    4 - Performance status (Karnofsky, Lansky) <70%
    5 - Patient having received other therapy for cancer treatment than those allowed as per the ongoing High Risk Neuroblastoma SIOPEN trial or as defined in the future frontlines protocol (for HRNBL1 trial : after induction + 2 TVD)
    6 - Impaired organ function (liver, kidney, heart, lungs)
    7 - Any uncontrolled intercurrent illness or infection that in the investigator’s opinion would impair study participation
    8 - Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
    9 - Patient allergic to peanut or soya
    10 - Chronic inflammatory bowel disease and/or bowel obstruction
    11 - Pregnant or breastfeeding women
    12 - Known hypersensitivity to the active substance or to any of the excipients of study drugs
    13 - Known hypersensitivity to dacarbazine
    14 - Concomitant use with St John's Wort
    1.Presenza di metastasi al sistema nervosa centrale
    2.Malattia in progressione al momento di ingresso nello studio
    3.Precedente terapia mieloablativa
    4.Performance status (Karnofsky o Lansky) <70%
    5.Trattamento precedente secondo programmi differenti dallo studio SIOPEN per neuroblastoma ad alto rischio
    6.Funzione d’organo alterata (epatica, renale, cardiaca, polmonare)
    7.Frazione di eiezione <28%, o <55% se accompagnata da segni di insufficienza cardiaca congestizia, o alterazioni del ritmo non controllate
    8.Dispnea a riposo o saturazione O2 <95% in aria ambiente
    9.Qualsiasi malattia incontrollata che potrebbe pregiudicare la aderenza al protocollo a giudizio dello sperimentatore
    10.Ipersensibilità nota ad uno o più medicinali o eccipienti in sperimentazione.
    E.5 End points
    E.5.1Primary end point(s)
    Event Free Survival (EFS) from the date of randomisation into the VERITAS trial
    Valutazione dell’event Free Survival (EFS) nei 3 anni successivi dalla data di randomizzazione
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 anni
    E.5.2Secondary end point(s)
    •Overall survival
    •Adverse events, evaluated using NCI-CTCAE v4.0 toxicity grading system, reported by treatment phase and overall over the whole treatment duration (maximum grade).
    •Disease response after BuMel and at the end of treatment
    •For the Q-TWiST analysis: time spent with severe toxicity after randomization and before progression/relapse (duration of hospitalisation will be used as a surrogate of time with toxicity); time spent without progression/relapse and without toxicity; and time from progression until death.
    •Feasibility of each strategy of intensified consolidation chemotherapy
    •Event-Free Survival from the date of start of the consolidation phase
    •Event-Free Survival from the date of the neuroblastoma diagnosis

    Valutazione della sopravvivenza globale
    • Valutazione dell’insorgenza degli eventi avversi valutati attraverso il NCI-CTCAE v4.0 system. La stopping rule per tossicità sarà basata sugli effetti collaterali che portano a ventilazione assistita in UTI e su eventi con tossicità letale. Questi eventi verranno monitorati nei 6 mesi successivi alla randomizzazione
    •Risposta della malattia al ciclo BuMel e alla fine delle cure
    •Per la Q-TWiST analysis: tempo intercorso tra tossicità severa dopo la randomizzazione e prima della progressione/ricaduta (con durata della ospedalizzazione come surrogate di tempo di tossicità); tempo trascorso in assenza di progressione/recidiva e senza tossicità; e tempo tra la progressione/ricaduta e il decesso.
    •Event-Free Survival dalla data di inizio della fase di consolidamento
    •Event-Free Survival dalla data di diagnosi di neuroblastoma
    E.5.2.1Timepoint(s) of evaluation of this end point
    *By treatment phase and on the whole treatment duration
    *At disease progression / relapse
    *At death
    8 anni
    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 No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Israel
    Italy
    Spain
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 150
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 28
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 111
    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: 5
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Written informed consent will be obtained from the patient or an approved guardian prior to performing any trial related procedure.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SIOPEN
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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