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    Summary
    EudraCT Number:2009-018077-31
    Sponsor's Protocol Code Number:012010
    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:2012-03-20
    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 number2009-018077-31
    A.3Full title of the trial
    A PHASE I/II DOSE SCHEDULE FINDING STUDY OF CH14.18/CHO CONTINUOUS INFUSION COMBINED WITH SUBCUTANEOUS ALDESLEUKIN (IL-2) IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSED NEUROBLASTOMA A SIOPEN Study
    Studio di fase I/II per dose e schedula dell'anticorpo monoclonale anti GD2 ch 14.18/CHO in infusione continua associato a Aldesleuchina (IL2) in pazienti con neuroblastoma refrattario o recidivato.
    A.3.2Name or abbreviated title of the trial where available
    Long term continuous infusion ch.14.18/CHO plus s.c IL2
    Infusione prolungata anticorpo ch.14.18/CHO e IL2
    A.4.1Sponsor's protocol code number012010
    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 SponsorSt. Anna Kinderkrebsforchung Children's Cancer Research Institute
    B.1.3.4CountryAustria
    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 supportSt. Anna Kinderkrebsforchung Children's Cancer
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Anna Kinderkrebsforchung Children's Cancer
    B.5.2Functional name of contact pointpromotore sperimentazione
    B.5.3 Address:
    B.5.3.1Street AddressZimmermannplaz 10 A-1090
    B.5.3.2Town/ cityVienna
    B.5.3.3Post codeA-1090
    B.5.3.4CountryItaly
    B.5.4Telephone number+43 (1) 40470-0
    B.5.5Fax number+43 (1) 40470-7150
    B.5.6E-mailladenstein@ccri.at
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namech.14.18/CHO
    D.3.2Product code N.A.
    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 INNAntineoplatics Agents
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codech.14.18/CHO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number4.6
    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) Yes
    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) Yes
    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.2.1.1.1Trade name PROLEUKIN
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAldesleukin
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.3Concentration number18
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeprodotto ricombinante
    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
    Advanced refractory or relapsed neuroblatoma
    Pazienti affetti da neuroblastoma refrattario o in ricaduta
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10066595
    E.1.2Term Neuroblastoma recurrent
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary :____ find a treatment plan that reduces the pain as tolerable profile tossicita'dell'anticorpo ch.14 18/CHO maintaining efficiency immunomodulation in patients (1 to 21 years) with refractory neuroblastoma (≥ 1 line of treatment conventional) or relapse using a 'prolonged and continuous infusion in combination with interleukin 2 (IL-2) sc
    Primario:____ trovare un piano di cura tollerabile che riduca il dolore quale profilo di tossicita’dell’anticorpo ch.14 18/CHO mantenendo l’efficienza immunomodulatoria in pazienti (da 1 a 21 anni) con Neuroblastoma refrattario (≥ 1 linee di trattamenti convenzionali) o in ricaduta usando un’ infusione prolungata e continua in combinazione con Interleukina 2 (IL-2) s.c.
    E.2.2Secondary objectives of the trial
    Assess pain intensity and relief with appropriate treatment with a validated instrument for self-documentation. • valid, during the first cycle of treatment, the correlations of activated NK cells and the level of ADCC using ch.14 18/CHO with MNC (mononucleoidi cell counts) and serum from patients on the fifteenth day. • Determine immune modulation resulting from the combined treatment of CH14. 18/CHO and sc Interleukin 2 (IL-2) by repeated analysis of NK cells, IL-2 soluble receptor, ADCC, CDC and antiidiotipo response (HAMA and HACA) • Obtain and increase the absolute count of lymphocytes and the absolute number of NK cells after each cycle as a measure of their response to IL-2 sc . • Determine the pharmacokinetics of ch.14 18/CHO. • Consider anti-tumor response resulting from this treatment plan using clinical findings in patients with measurable disease. • Confirm the results of the type of fixed-term infusion ch.14 18/CHO further 20 counts in patients.
    •Valut. l’intensita' del dolore e il sollievo con l’opportuno trattamento con uno strumento di auto-documentazione validato.•Validare,durante il primo ciclo di trattamento,le correlazioni di cellule NK attivate e il livello di ch.14 18/CHO con ADCC usando MNC(conta cellule mononucleoidi)e siero dai paz al quindicesimo giorno.•Det. immuno modulazione risultante dal trattamento combinato di ch14.18/CHO and s.c.Interleukina 2(IL-2)mediante analisi ripetute di cellule NK,IL-2 recettore solubile,ADCC,CDC e risposta antiidiotipo(HAMA and HACA)•Ottenere e aumentare la conta assoluta di linfociti e il numero assoluto di cellule NK dopo ogni ciclo rispettivo come misura della risposta all’IL-2 s.c..•Det. la farmacocinetica di ch.14 18/CHO.•Valut. risposta anti-tumorale risultante da questo piano di trattamento usando accertamenti clinici in paz con malattia misurabile.•Confermare i risultati del tipo di durata di infusione determinato di ch.14 18/CHO in una conta ulteriore 20 paz.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Neuroblastoma patients with> 1 and ≤ 21 years, we have received at least one prior treatment with high doses followed by reinfusion of hematopoietic stem cells after conventional therapy to reduce tumor burden and meet any of the following criteria: • Refractory Neuroblastoma stage 4 with at least 2 lines of treatment before further doses resulting in an interval between diagnosis and transplantation of more than 9 months. Relapse res.in stage 4 • responsive metastatic recurrence after diagnosis of localized neuroblastoma
    Pazienti con neuroblastoma con &gt;1 e ≤ 21 anni , che abbiamo ricevuto almeno un precedente trattamento ad alte dosi seguito da reinfusione di cellule staminali emopoietiche dopo terapia convenzionale per ridurre il carico tumorale e che soddisfino uno dei seguenti criteri: • Neuroblastoma refrattario in stadio 4 con almeno 2 linee di trattamento prima di altre dosi causando un intervallo tra diagnosi e trapianto di piu' di 9 mesi. Ricaduta res.in stadio 4 • Recidiva metastatica responsiva dopo diagnosi di Neuroblastoma localizzato
    E.4Principal exclusion criteria
    Progressive disease and / or previous treatment with ch.14.18/SP2/0 and / or ch14.18CHO
    Malattia progressiva e/o trattamento precedente con ch.14.18/SP2/0 e/o ch14.18CHO
    E.5 End points
    E.5.1Primary end point(s)
    To find a tolerable treatment schedule which reduces the pain-toxicity profile of ch14.18/CHO whilst maintaining immunomodulatory efficacy in patients (1-21 years old) with either primary refractory (≥ 2 lines of conventional treatment) or relapsed neuroblastoma by using a prolonged continuous infusion in combination with s.c aldesleukin (IL-2).
    riduzione del dolore quale tossicita' dell'anticorpo ch.14.18/CHO e IL2 s.c. mantenendone l' efficenza immunomodulatoria in pazienti con neuroblastoma refrattaria o in ricaduta.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Australia
    Israel
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    18 months
    È prevedibile che il reclutamento duri fino a 18 mesi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.1Number of subjects for this age range: 0
    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.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    minori
    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 58
    F.4.2.2In the whole clinical trial 60
    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 Decision2011-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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