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    Summary
    EudraCT Number:2019-000742-35
    Sponsor's Protocol Code Number:RTBAIEOP018
    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:2021-05-24
    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 number2019-000742-35
    A.3Full title of the trial
    PROTOCOL FOR THE DIAGNOSIS AND THERAPY OF INTRAOCULAR RETINOBLASTOMA
    PROTOCOLLO DIAGNOSTICO E TERAPEUTICO DEL RETINOBLASTOMA INTRAOCULARE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROTOCOL FOR THE DIAGNOSIS AND THERAPY OF INTRAOCULAR RETINOBLASTOMA
    PROTOCOLLO DIAGNOSTICO E TERAPEUTICO DEL RETINOBLASTOMA INTRAOCULARE
    A.3.2Name or abbreviated title of the trial where available
    RTB AIEOP 018
    RTB AIEOP 018
    A.4.1Sponsor's protocol code numberRTBAIEOP018
    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 SponsorASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPBG- Ospedale Pediatrico Bambino Gesu'
    B.5.2Functional name of contact pointClinical trial office- Dipartimento
    B.5.3 Address:
    B.5.3.1Street AddressPiazza di Sant'Onofrio, 4
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00165
    B.5.3.4CountryItaly
    B.5.4Telephone number0668593697
    B.5.5Fax number0668592292
    B.5.6E-mailmgiuseppina.cefalo@opbg.net
    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 nameCarboplatino
    D.3.2Product code [Carbo]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarboplatino
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeCarboplatino
    D.3.9.3Other descriptive nameCarboplatin
    D.3.9.4EV Substance CodeSUB06614MIG
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 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.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.2Product code [Topotecan]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOPOTECAN
    D.3.9.1CAS number 123948-87-8
    D.3.9.2Current sponsor codeTopotecan
    D.3.9.3Other descriptive nameTopotecan
    D.3.9.4EV Substance CodeSUB11191MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameVincristina Solfato
    D.3.2Product code [Vcr]
    D.3.4Pharmaceutical form Solution 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 INNVINCRISTINA SOLFATO
    D.3.9.1CAS number 57-22-7
    D.3.9.2Current sponsor codeVcr
    D.3.9.3Other descriptive namevincristine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEtoposide
    D.3.2Product code [VP16]
    D.3.4Pharmaceutical form 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 INNETOPOSIDE
    D.3.9.1CAS number 33419-42-0
    D.3.9.2Current sponsor codeVP16
    D.3.9.3Other descriptive nameEtoposide
    D.3.9.4EV Substance CodeSUB07337MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 5
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation number-
    D.3 Description of the IMP
    D.3.1Product nameMelfalan Cloridrato
    D.3.2Product code [Melphalan]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    Intravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMELFALAN CLORIDRATO
    D.3.9.1CAS number 148-82-3
    D.3.9.2Current sponsor codeMelphalan
    D.3.9.3Other descriptive nameMelphalan
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Intraocular retinoblastoma
    Retinoblastoma intraoculare
    E.1.1.1Medical condition in easily understood language
    Intraocular retinoblastoma
    Retinoblastoma intraoculare
    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 PT
    E.1.2Classification code 10038916
    E.1.2Term Retinoblastoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10038916
    E.1.2Term Retinoblastoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10038916
    E.1.2Term Retinoblastoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10038916
    E.1.2Term Retinoblastoma
    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
    For patients with intraocular retinoblastoma, the main objective is to achieve at least 60% ocular survival, 24 months after diagnosis, through the proposed conservative treatment scheme, without recourse to TEN or secondary enucleation ( EFS). The proposed conservative treatment scheme, detailed in paragraph 5, provides for the introduction in the first line of chemotherapy by intra-arterial (Melphalan and Topotecan), intravitreal (Melphalan) and peribulbar (Carboplatin and Topotecan) routes.
    Per i pazienti affetti da retinoblastoma intraoculare, l’obiettivo principale dello studio è raggiungere una sopravvivenza oculare, a 24 mesi dalla diagnosi, di almeno il 60% mediante lo schema di trattamento conservativo proposto, senza il ricorso alla RTE o all’enucleazione secondaria (EFS). Lo schema di trattamento conservativo proposto, ben dettagliato nel paragrafo 5, prevede l’introduzione in prima linea della chemioterapia per via intra-arteriosa (Melphalan e Topotecan), intravitreale (Melphalan) e peribulbare (Carboplatino e Topotecan).
    E.2.2Secondary objectives of the trial
    TOXICITY
    The evaluate the systemic and local toxicity, short, medium and long term, of systemically or locally administered chemotherapy (intra-arterial, intravitreal and peribulbar) and focal eye treatments
    VISUAL OUTCOME
    To evaluate the residual visual function, at distance, of patients in conservative treatment.
    CLASSIFICATION SYSTEM
    To prospectively validate the 8th edition of the TNM Staging System (69) for the staging of intraocular disease, and for analysis of the histological risk factors of the enucleated eyeball d'emblée or post conservative treatment
    TOSSICITA’
    Valutare la tossicità sistemica e locale, a breve, medio e lungo termine, della chemioterapia somministrata per via sistemica o locale (intra-arteriosa, intravitreale e peribulbare) e dei trattamenti oculari focali.
    OUTCOME VISIVO
    Valutare la residua funzione visiva, a distanza, dei pazienti avviati a trattamento conservativo.
    SISTEMA DI CLASSIFICAZIONE
    Validare prospetticamente la 8° edizione del TNM Staging System (69) per la stadiazione di malattia intraoculare, e per l’analisi dei fattori di rischio istologici del bulbo oculare enucleato d’ emblée o post trattamento conservativo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinical diagnosis of single or bilateral intraocular Retinoblastoma (stage 0 according to "International Retinoblastoma Staging System-IRSS")
    • Patients <16 years old
    • No previous chemo or radiotherapy treatment
    . Ophthalmological evaluation with Fundus Cam Overview and classification of intraocular lesions according to "International Intraocular Retinolastoma Classification-IIRC" - Performance status: Lansky = 50
    • Written informed consent signed by parents or legal guardian
    - Diagnosi di retinoblastoma intraoculare monolaterale e/o bilaterale (stadio 0 secondo “International Retinoblastoma Staging System-IRSS”)
    - Età <16 anni
    -Nessun precedente trattamento radioterapico né chemioterapico sistemico e/o locale
    - Valutazione oftalmologica con Fundus Cam Panoramica e classificazione delle lesioni intraoculari secondo “International Intraocular Retinolastoma Classification-IIRC” - Performance status: Lansky = 50
    - Consenso informato scritto e firmato dai genitori o dal tutore legale del paziente
    E.4Principal exclusion criteria
    • Patients = 16 years old
    • Patients not evaluated with panormic Fundus-Cam at diagnosis
    • Patients who have received prior chemo or radiotherapy treatments
    • Ongoing pregnancy or breastfeeding
    • Hypersensitivity to any component of the study drugs
    • Vaccination with live and attenuated virus
    • Subjects with neuromuscular disorders
    • Presence of exclusion criteria for conservative treatment
    • Absence of eligibility criteria for the study
    - Pazienti di età = 16 anni
    - Pazienti non valutati con Fundus-Cam panormica alla diagnosi
    - Pazienti che hanno ricevuto precedenti trattamenti chemio o radioterapici
    - Gravidanza o allattamento in corso
    - Ipersensibilità nota a qualsiasi componente dei farmaci in studio
    - Vaccinazione con vaccini a virus vivi ed attenuati
    - Soggetti affetti da disturbi neuromuscolari
    - Presenza di criteri di esclusione al trattamento conservativo
    - Assenza dei criteri di eleggibilità allo studio
    E.5 End points
    E.5.1Primary end point(s)
    ocular EFS
    EFS oculare
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    Medium and long-term systemic and ocular toxicity; visual outcome; Validation of the 8th edition of the TNM Staging System as a staging system
    Tossicità sistemica e oculare a medio e lungo termine;; Outcome visivo; Validazione dell’8° edizione del TNM Staging System quale sistema di Stadiazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA; 4 years; NA
    ND; 4 anni; ND
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    Last follow-up visit (10 years after the end of treatment) of the last patient
    LVLS
    Ultima visita di follow-up (10 anni dopo la fine del trattamento) dell'ultimo paziente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years14
    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 years14
    E.8.9.2In all countries concerned by the trial months0
    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) 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: 34
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children
    Minori
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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)
    The subjects will be treated according to the proposed treatment for a period varying from 3 months to 6 months. At the end of the study, patients will be followed for at least 10 years to evaluate possible distant toxicity.
    I soggetti saranno trattati secondo trattamento proposto per un periodo variabile dai 3 mesi ai 6 mesi. Al termine dello studio i pazienti saranno seguiti per almeno 10 anni per valutare possibili tossicità a distanza.
    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 Decision2021-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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