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    Summary
    EudraCT Number:2006-001489-17
    Sponsor's Protocol Code Number:SIOPENRNET003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-05-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2006-001489-17
    A.3Full title of the trial
    High risk neuroblastoma study 1.8 of SIOP-Europe - SIOPEN – (HR-NB-L1.8/SIOPEN)
    Europejski Program Leczenia Dzieci z Neuroblastoma Wysokiego Ryzyka, wersja 1.8 (High risk neuroblastoma study 1.8 of SIOP-Europe - SIOPEN) – (HR-NB-L1.8/SIOPEN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to optimise the treatment for high risk neuroblastoma patients
    Optymalizacja leczenia pacjentów z nowotworem neuroblastoma wysokiego ryzyka.
    A.3.2Name or abbreviated title of the trial where available
    HR-NBL-1.8
    A.4.1Sponsor's protocol code numberSIOPENRNET003
    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 SponsorJagiellonian University Medical College
    B.1.3.4CountryPoland
    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 supportJagiellonian University Collegium Medicum
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinika Onkologii i Hematologii Dziecięcej
    B.5.2Functional name of contact pointprof. Walentyna Balwierz
    B.5.3 Address:
    B.5.3.1Street Addressul Wielicka 265
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code30-663
    B.5.3.4CountryPoland
    B.5.4Telephone number+4812333 92 20
    B.5.5Fax number+4812658 76 51
    B.5.6E-mailwalentyna.balwierz@uj.edu.pl
    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.2.1.1.1Trade name Dinutuximab beta
    D.2.1.1.2Name of the Marketing Authorisation holderEUSA Pharma (UK) Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/12/1062
    D.3 Description of the IMP
    D.3.1Product nameDinutuximab beta
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNdinutuximab beta
    D.3.9.3Other descriptive namech14.18/CHO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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 Yes
    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 AuthorisationEuropean Union
    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 Powder for injection
    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.3.9.1CAS number 110942-02-4
    D.3.9.2Current sponsor codeProleukin
    D.3.9.3Other descriptive nameALDESLEUKIN
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Yes
    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
    High Risk Neuroblastoma
    Neuroblastoma Wysokiego Ryzyka (nerwiak zarodkowy współczulny)
    E.1.1.1Medical condition in easily understood language
    Neuroblastoma is the most common extracranial solid cancer in childhood and the most common cancer in infancy
    Neuroblastoma jest najczęstszym guzem litym występującym poza OUN u dzieci i najczęstszym nowotworem występującym u niemowlat
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To test the hypothesis that the addition of subcutaneous aldesleukin
    (IL-2, (Proleukin®)) to immunotherapy with Dinutuximab beta EUSA
    given as continuous infusion in addition to differentiation therapy with
    isotretinoin (13-cis-RA) following myeloablative therapy (MAT) and
    autologous stem cell rescue, will improve EFS in patients with high-risk
    neuroblastoma (stage 4 disease or stages 2 and 3 with MYCN
    amplification, all over the age of one, or infants with MYCN
    amplification) (R4 randomisation).
    - To correlate molecular biological features with metastatic and primary
    tumour response, event free and overall survival (EFS, OS) as well as
    with respective treatment elements and phases.
    - przetestowanie hipotezy że dodanie podskórnej aldesleukiny (IL-2, Proleukin) do immunoterapii z zastosowaniem Dinutuximabu beta EUSA podawanego w infuzji ciągłej razem z terapią różnicująca z zastosowaniem isotretinoiny (13-cis-RA) po terapii mieloablacyjnej (MAT) i autologicznym przeszczepieniu macierzystych komórek krwiotwórczych poprawi EFS u Pacjentów z neuroblastoma wysokiego ryzyka ( stopień 4, stopień 2 lub 3 z amplifikacją MYCN u Pacjentów powyżej 1 r.ż lub u niemowląt z amplifikacją MYCN)
    - korelacja obecnych w komórkach guza zaburzeń molekularnych z odpowiedzią na leczenie guza pierwotnego i przerzutów, czasem wolnym od niekorzystnych zdarzeń (EFS) i czasem przeżycia całkowitego w odniesieniu do odpowiedniego etapu leczenia
    E.2.2Secondary objectives of the trial
    •To test the molecular - biological profile of disseminating tumour cells
    (DTCs) obtained via liquid biopsies in comparison with molecular -
    biological profiles in BM and primary tumour at diagnosis and respective
    specified response and follow up time points to validate the value of
    liquid biopsies for future follow up and to correlate above parameters
    with EFS and OS.
    •To evaluate BM response to Rapid COJEC (after the fourth and eight
    cycles with ICH-GD2, AIPF and QRT-PCR.
    •To determine the effect of response of metastatic disease to induction therapy
    therapy on EFS and overall survival (OS) with mIBG/SPECT SIOPEN
    stand scoring of skeletal response
    •To investigate the relationship between complete surgical resection of
    the primary tumour on EFS and OS within the scope of established
    standard treatments.
    • ocena molekularno-biologicznego profilu rozprzestrzeniania się komórek nowotworowych (DTC) uzyskane za pomocą biopsji płynnych w porównaniu z molekularno-biologicznym profilem w BM i guzie pierwotnym w momencie rozpoznania i odpowiednie określona odpowiedź i dalsze punkty czasowe w celu potwierdzenia wartości biopsje płynne do przyszłych obserwacji i do skorelowania powyższych parametrów z EFS i OS.
    • ocena odpowiedzi BM na Rapid COJEC (po czwartym i ósmym cyklu z ICH-GD2, AIPF i QRT-PCR.
    - ocena wpływu odpowiedzi przerzutów na terapię indukcyjną na EFS i przeżycia całkowite (OS)
    • Zbadanie związku między całkowitą chirurgiczną resekcją guza pierwotnego na EFS i OS w ramach leczenia standardowego.
    - zgromadzenie danych dotyczących wyselekcjonowanych i walidowanych danych biologicznych i ocena ich wpływu na EFS, odsetek wznów/progresji oraz OS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS)
    - Age below 21 years.
    - High-risk neuroblastoma, defined as either:
    a) INSS stages 2, 3, 4 and 4s with MYCN amplification, or
    b) INSS stage 4 without MYCN amplification aged ≥ 12 months
    - Patients who have received no previous chemotherapy except for 1 cycle of etoposide and carboplatin (Vp/Carbo). In this situation patients will receive Rapid COJEC induction and the first COJEC cycle may be replaced by the first cycle of Vp/Carbo.
    - Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met.
    - Tumour cell material available for determination of biological prognostic factors.
    - Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis.
    - Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
    - Provisional follow up of 5 years.
    - National and local ethical committee approval.
    - ustalona diagnoza neuroblastoma zgodnie z międzynarodowymi kryteriami International Neuroblastoma Staging System (INSS)
    - wiek poniżej 18 r. ż.
    - neuroblastoma wysokiego ryzyka definiowana jako jedno z poniższych
    a) Stopień 2,3,4 i 4s wg. INSS z amplifikacją MYCN lub
    b) Stopień 4 wg INSS bez amplifikacji MYCN w wieku ≥ 12 miesięcy
    - Pacjenci nie otrzymujacy wczesniej chemioterapii z wyjątkiem 1 cyklu etopozydu z karboplatyną (Vp/Carbo). W takiej sytuacji Pacjenci otrzymuja indukcję Rapid-COJEC, a 1 cykl COJEC może być zamieniony na 1 cykl Vp/Carbo
    - uzyskanie świadomej pisemnej zgody, w tym zgody rodziców lub przedstawicieli ustawowych dla małoletnich na udział w badaniu randomizowanym o ile spełnione sa kryteria randomizacji
    - materiał guza zachowany do oceny biologicznych czynników prognostycznych
    - rejestracja wszystkich informacji dotyczących kryteriów włączenia do badania w bazie danych w ciągu 6 tygodni od diagnozy
    - kobiety w wieku rozrodczym musza mieć ujemny test ciążowy. Pacjenci w wieku rozrodczym muszą zgodzić się na stosowanie skutecznych metod antykoncepcyjnych. Kobiety karmiące piersią muszą zgodzić się na zakończenie karmienia.
    - przewidywany czas obserwacji Pacjentów: 5 lat
    - zgoda Komisji Bioetycznej
    E.4Principal exclusion criteria
    Any negative answer concerning the inclusion criteria of the study and R4 will render the patient ineligible for the corresponding therapy phase.
    Niewypełnienie dowolnego z kryteriów włączenia do badania i randomizacji R4, dyskwalifikuje Pacjenta z odpowiedniej fazy terapii.
    E.5 End points
    E.5.1Primary end point(s)
    Randomisation 4:
    The primary endpoint is Event Free Survival calculated from the date of the R4- randomisation. The following will be considered as events:
    - disease progression or relapse,
    - death from any cause
    - second neoplasm.

    Patients lost to follow-up without event will be censored at the date of their last follow-up evaluation.
    Pierwszorzędowe punkty końcowe
    Pierwszorzędowym punktem końcowym jest przeżycie wolne od niekorzystnych wydarzeń (EFS) obliczane od daty randomizacji R4. Jako zdarzenie definiowane będzie wystąpienie jednego z poniższych punktów:
    - progresja lub wznowa choroby,
    - zgon z dowolnej przyczyny,
    - drugi nowotwór.
    Jeżeli pacjenci zostaną utraceni z badania, obserwacja będzie zakończona z datą ostatniej kontroli
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will be performed 1 year for R4 after the inclusion of the last patient.
    Analiza końcowa dla randomizacji R4 zostanie wykonana 1 rok po włączeniu ostatniego pacjenta.
    E.5.2Secondary end point(s)
    Secondary endpoints of the main trial
    - Overall survival
    Calculated from date of randomisation to death from any cause. Patients lost to follow-up without an event will be censored at the date of their last follow-up evaluation.
    - Cumulative incidence of relapse/progression and deaths without relapse/progression
    - The cumulative incidence of treatment related mortality and of disease related mortality
    - Response
    Overall response (incl. primary tumour after induction), skeletal response on MIBG, BM-response,
    - Toxicity
    in particular comparison of the frequency of episodes of febrile neutropenia and grade 3-4 infections during induction (modified N7 vs. Cojec)
    - Response rates, survival, EFS and the cumulative incidence of relapse/progressions will be related to potential prognostic factors including:
    - Biological factors (MYCN amplification, SCAs, expression signature) of neuroblastoma cells in the bone marrow and/or the primary tumour.
    - Serological factors (serum concentrations at diagnosis of LDH, ferritin, neuron specific enolase).
    - Urinary catecholamines at diagnosis (VMA, HVA, Dopamine)
    - przeżycie całkowite liczone od daty randomizacji do zgonu z dowolnej przyczyny. U pacjentów utraconych z obserwacji bez zdarzenia dane zostaną ucięte z datą ostatniej obserwacji.
    - kumulacyjna częstość występowania wznów/progresji choroby i zgonów bez wznowy/progresji
    - kumulacyjna częstość śmiertelności związanej z leczeniem i śmiertelności związanej z chorobą
    - Odpowiedź na leczenie
    Odpowiedź całkowita (w tym odpowiedź guza pierwotnego po indukcji), odpowiedź przerzutów w układzie kostnym po MIBG i odpowiedź przerzutów w szpiku kostnym
    - Toksyczności
    Porównywana będzie w szczególności częstość epizodów gorączki neutropenicznej i infekcji w stopniu 3 i 4 po indukcji
    - Odsetek pacjentów, którzy nie ukończyli leczenia (zwłaszcza dla randomizacji R4)
    Odsetek odpowiedzi, przeżycie, EFS i kumulacyjna częstość wznów/progresji będzie oceniana w korelacji z potencjalnymi czynnikami prognostycznymi, w tym:
    - czynnikami biologicznymi (amplifikacja MYCN, SCA, profil ekspresji) komórek neuroblastoma w szpiku kostnym i/lub w guzie pierwotnym
    - czynnikami serologicznymi (stężenie w surowicy w momencie diagnozy LDH, ferrytyny, enolazy neurospecyficznej).
    - stężeniem katecholamin w moczu w momencie diagnozy (VMA, HVA, Dopaminy)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analysis will be performed after the inclusion of the last patient.
    Analiza końcowa zostanie wykonana 1 rok po włączeniu ostatniego pacjenta
    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 No
    E.6.10Pharmacogenetic Yes
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Indukacja Rapid COJEC
    Rapid Cojec Induction
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Austria
    Belgium
    China
    Czech Republic
    Denmark
    Finland
    France
    Greece
    Hong Kong
    Hungary
    Ireland
    Israel
    Italy
    Norway
    Poland
    Portugal
    Serbia
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years15
    E.8.9.2In all countries concerned by the trial months3
    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: 3300
    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: 653
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2558
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 77
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-05-22. Yes
    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
    infants, toddlers, children
    dzieci
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2300
    F.4.2.2In the whole clinical trial 3300
    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)
    patients are enrolled in a 5-year follow-up period, no further treatment planned
    pacjenci będą włączani z 5-letnim okresem obserwacji, nie planuje się dalszego leczenia
    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 Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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