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    Summary
    EudraCT Number:2010-022235-10
    Sponsor's Protocol Code Number:ITCC-015/EWOG-MDS-Azacytidine-2010
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-04
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-022235-10
    A.3Full title of the trial
    A Phase I/II study of Azacitidine (Vidaza®) in pediatric patients with relapsed high-grade pediatric MDS or JMML
    Een fase I/II studie met azacitidine in kinderen met recidief hooggradig MDS of JMML
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Azacitidine in children with MDS or JMML
    Azacitidine in kinderen met MDS of JMML
    A.3.2Name or abbreviated title of the trial where available
    Azacitidine in high grade MDS and JMML pediatric patients
    Azacitidine in kinderen met hooggradig MDS of JMML
    A.4.1Sponsor's protocol code numberITCC-015/EWOG-MDS-Azacytidine-2010
    A.5.4Other Identifiers
    Name:NTR 2578Number:Nederlands Trial Register
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportGo4Children Foundation
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Office
    B.5.2Functional name of contact pointR. Hoogendijk
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31107036568
    B.5.5Fax number31107036681
    B.5.6E-mailtrialmanagement@erasmusmc.nl
    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 vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA86359
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320672
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Relapsed advanced Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leukemia (JMML)
    Gerecidiveerde vergevorderde myelosyplastich syndroom (MDS) en Juveniele Myelomonocytraire leukemie (JMML)
    E.1.1.1Medical condition in easily understood language
    MDS and JMML
    preleukemie en JMML
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10054439
    E.1.2Term Juvenile chronic myelomonocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068361
    E.1.2Term MDS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The current study aims to establish the recommended dose, safety and preliminary efficacy of azacitidine administered IV or SC in children with relapsed/refractory MDS or JMML, in 2 different subgroups (strata) of patients.
    De huidige studie beoogt het vaststellen van de aanbevolen dosering, veligheid en de voorlopige effectiviteit van azacitidine (vidaza) per intraveneuze of subcutane toediening bij kinderen met vergevorderde (recidief/refractair) MDS en JMML, verdeeld over 2 subgroepen.
    E.2.2Secondary objectives of the trial
    • To determine the safety and tolerability of azacitidine per stratum.
    • To determine (preliminary) the hematological remission rate in these patients.
    • To describe the durability of response and long-term follow-up, including that of patients undergoing stem-cell transplant after treatment with azacitidine.
    • To determine the pharmacokinetics of azacitidine in plasma.
    • To study the pharmacodynamic effects of azacitidine in pediatric MDS and JMML.
    • To describe the number of patients transforming into AML
    • het vaststellen van de veiligheid en verdraagzaamheid van azacitidine per stratum.
    • het vaststellen van de(preliminaire) hematologsiche remissie verhouding.
    • het omschrijven van de responseduur en lange termijn follow-up inclusief die van patiënten die stamceltransplantatie hebben gehad na azacitidine.
    • het vaststellen van de farmacokinetiek van azacitidine in plasma
    • het bestuderen van de pharmacodynamische effecten van azacitidine in MDS bij kinderen en JMML.
    • het aantal patienten beschrijven die naar AML transformeren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of relapsed advanced primary MDS or JMML, established at initial diagnosis by the diagnostic criteria as specified in the EWOG-MDS 2006 protocol (see appendix 1), and defined as:
    o Relapsed MDS:
    After a documented CR or PR, this designation is defined as
    - a reappearance of blasts in the peripheral blood,
    - or ≥5% blasts in the bone marrow not attributable to any other cause (e.g. bone marrow regeneration after consolidation therapy), and confirmed with flowcytometry.
    o Relapsed JMML:
    After a documented CR or PR, this designation is defined as
    - reappearance of organomegaly
    - in combination with elevated WBC with peripheral blood monocytosis (greater than 1x109/l),
    - and/or the reappearance of a cytogenetic or molecular lesion indicative of prior disease.
    - In addition, clinical criteria may be used, which include objective parameters such as increase in spleen size of >50% from baseline, and/or the appearance of new skin lesions, and/or oxygen need,
    - and/or blast crises/transformation to AML.
    • 1 month to ≤ 18 years old
    • Lansky play score ≥ 60; or Karnofsky performance status ≥ 60 (appendix 2)
    • Life expectancy  3 months
    • Normal renal function defined as less than or equal to NCI-CTCAE grade 1 (max 1.5 x ULN).
    • Normal liver function defined as less than or equal to NCI-CTCAE grade 1 (max 2.5 x ULN for transaminases and bilirubin)
    • No chemotherapy within 3 weeks of start of study medication. For 6-MP or low-dose cytarabine in JMML patients 1 week wash-out time is sufficient.
    • For JMML patients: saturation >92% without additional supply of oxygen
    • For JMML patients: peripheral blood monocyte count greater than 1.0x109/l
    • For relapsed patients following HSCT: recovery of all acute toxic effects of prior chemotherapy/stem-cell transplantation.
    • Able to comply with scheduled follow-up and with management of toxicity.
    • Reproductive Function
    • Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
    • Female patients with infants must agree not to breastfeed their infants while on this study.
    • Male and female patients of child-bearing potential must agree to use an highly effective method of contraception approved by the investigator during the study and for 90 days after the last dose of azacitidine.
    • Highly effective methods of contraception include (but not exclusively) the following contraceptive methods:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
    • progestogen-only hormonal contraception associated with inhibition of ovulation
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system ( IUS)
    • sexual abstinence.
    • Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.
    Diagnose van recidiverende geavanceerde primaire MDS of JMML, vastgesteld bij de initiële diagnose door de diagnostische criteria zoals gespecificeerd in het EWOG-MDS 2006-protocol (zie bijlage 1), en gedefinieerd als:
    o recidevernde MDS:
    Na een gedocumenteerde CR of PR wordt dit gedefinieerd als
    - opnieuw verschijnen van blasten in het perifere bloed,
    - of ≥ 5% blasten in het beenmerg die niet kunnen worden toegeschreven aan een andere oorzaak (bijvoorbeeld regeneratie van het beenmerg na consolidatietherapie) en bevestigd met flowcytometrie.
    o recidiverende JMML:
    Na een gedocumenteerde CR of PR wordt dit gedefinieerd als
    - terugkeer van organomegalie
    - in combinatie met verhoogde WBC met perifere bloedmonocytose (groter dan 1x109 / l),
    - en / of het terugkeren van een cytogenetische of moleculaire laesie die een indicatie is van een eerdere ziekte.
    - Daarnaast kunnen klinische criteria worden gebruikt, waaronder objectieve parameters zoals toename van de miltgrootte> 50% ten opzichte van de uitgangswaarde en / of het verschijnen van nieuwe huidlaesies en / of zuurstofbehoefte,
    - en / of blastcrises / transformatie naar AML.
    • 1 maand tot ≤ 18 jaar oud
    • Lansky-playscore ≥ 60; of Karnofsky-performance status ≥ 60 (bijlage 2)
    • Levensverwachting  3 maanden
    • Normale nierfunctie gedefinieerd als kleiner dan of gelijk aan NCI-CTCAE graad 1 (max. 1,5 x ULN).
    • Normale leverfunctie gedefinieerd als kleiner dan of gelijk aan NCI-CTCAE graad 1 (max. 2,5 x ULN voor transaminasen en bilirubine)
    • Geen chemotherapie binnen 3 weken na aanvang van de studiemedicatie. Voor 6-MP of lage dosis cytarabine bij JMML-patiënten is 1 week wash-outtijd voldoende.
    • Voor JMML-patiënten: verzadiging> 92% zonder extra toevoer van zuurstof
    • Voor JMML-patiënten: perifeer bloedmonocytenaantal groter dan 1,0x109 / l
    • Voor recidiverende patiënten na HSCT: herstel van alle acute toxische effecten van eerdere chemotherapie / stamceltransplantatie.
    • In staat om te voldoen aan geplande follow-up en het onder controle houden van toxiciteit.
    • Reproductieve functie
    • Vrouwelijke patiënten in de vruchtbare leeftijd moeten vóór inclusie een negatieve urine- of serumzwangerschapstest hebben bevestigd.
    • Vrouwelijke patiënten met baby's moeten ermee instemmen om hun baby's geen borstvoeding te geven tijdens deze studie.
    • Mannelijke en vrouwelijke patiënten in de vruchtbare leeftijd moeten ermee akkoord gaan dat tijdens de studie en gedurende 90 dagen na de laatste dosis azacitidine een door de onderzoeker aanbevolen en zeer effectieve anticonceptiemethode wordt gebruikt.
    • Zeer effectieve anticonceptiemethoden omvatten (maar niet uitsluitend) de volgende anticonceptiemethoden:
    • gecombineerde (oestrogeen en progestageen bevattende) hormonale anticonceptie geassocieerd met remming van de eisprong
    • progestageen-alleen hormonale anticonceptie geassocieerd met remming van de eisprong
    • intra-uterine apparaat (IUD)
    • intra-uterien hormoonafgiftesysteem (IUS)
    • seksuele onthouding.
    • Schriftelijke geïnformeerde toestemming van patiënten of van ouders of wettelijke voogden voor minderjarige patiënten, volgens de lokale wet- en regelgeving.
    E.4Principal exclusion criteria
    • Other serious illnesses or medical conditions
    • Genetic abnormalities indicative of AML
    • JMML patients in whom a diagnosis of Noonan syndrome is suspected based on clinical history and/or presenting symptoms
    • Patients with secondary MDS with underlying bone-marrow failure syndromes or with familial MDS
    • Isolated extramedullary disease
    • Symptomatic CNS-involvement
    • Current uncontrolled infection
    • Cardiac toxicity (shortening fraction below 28%)
    • Concurrent treatment with any other anti-cancer therapy is not allowed
    • Pregnant or lactating patients
    • Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons
    • Patient with expected non-compliance to toxicity management guidelines
    • Prior treatment with a demethylating agent
    • Allergy to azacitidine or mannitol.
    - Ernstige onderliggende ziekte
    • Andere ernstige ziekten of medische aandoeningen
    • Genetische afwijkingen die wijzen op AML
    • JMML-patiënten bij wie de diagnose van het Noonan-syndroom wordt vermoed op basis van de klinische geschiedenis en / of de presentatie van symptomen
    • Patiënten met secundaire MDS met onderliggend beenmergfalen of met familiale MDS
    • Geïsoleerde extramedullaire ziekte
    • Symptomatische CNS-betrokkenheid
    • Actuele ongecontroleerde infectie
    • Cardiale toxiciteit (verkortingsfractie lager dan 28%)
    • Gelijktijdige behandeling met andere antikankertherapie is niet toegestaan
    • Zwangere of borstvoedende patiënten
    • Patiënten die niet regelmatig gevolgd kunnen worden om psychologische, sociale, familiale of geografische redenen
    • Patiënt waarvan verwacht wordt dat zij de richtlijnen voor toxiciteit niet naleven.
    • Voorafgaande behandeling met een demethylerend middel
    • Allergie voor azacitidine of mannitol.
    E.5 End points
    E.5.1Primary end point(s)
    The current study aims to establish the recommended dose, safety and preliminary efficacy of azacitidine administered IV or SC in children with relapsed/refractory primairy or secondary MDS or JMML, in 2 different subgroups (strata) of patients.
    De huidige studie beoogt het vaststellen van de aanbevolen dosering, veligheid en de voorlopige effectiviteit van azacitidine (vidaza) per intraveneuze of subcutane toediening bij kinderen met vergevorderde (recidief/refractair) MDS en JMML, verdeeld over 2 subgroepen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint may be limited by Dose Limiting toxicities in cycle 1 but otherwise full evaluation of the primary endpoint is possible after of treatment and after end of study.
    Het primair eindpunt kan bij veel voorkomende DLT's al mogelijk worden vastgesteld. Bij normale inclusie en verloop is het primair eindpunt volledig evalueerbaar na inlusie van alle patiënten.
    E.5.2Secondary end point(s)
    Other objectives concern:
    • To determine the safety and tolerability of azacitidine per stratum.
    • To determine (preliminary) the hematological remission rate in these patients.
    • To describe the durability of response and long-term follow-up, including that of patients undergoing stem-cell transplant after treatment with azacitidine.
    • To determine the pharmacokinetics of azacitidine in plasma.
    • To study the pharmacodynamic effects of azacitidine in pediatric MDS and JMML.
    • To describe the number of patients transforming into AML
    • het vaststellen van de veiligheid en verdraagzaamheid van azacitidine per stratum.
    • het vaststellen van de(preliminaire) hematologsiche remissie verhouding.
    • het omschrijven van de responseduur en lange termijn follow-up inclusief die van patiënten die stamceltransplantatie hebben gehad na azacitidine.
    • het vaststellen van de farmacokinetiek van azacitidine in plasma
    • het bestuderen van de pharmacodynamische effecten van azacitidine in MDS bij kinderen en JMML.
    • het aantal patienten beschrijven die naar AML transformeren
    E.5.2.1Timepoint(s) of evaluation of this end point
    For most endpoints after 3 cycles, and others after 1 year after HSCT or 1 year after last treatment with azacitidine when no HSCT is given
    Voor de meeste eindpunten na 3 cycli, andere na 1 jaar na de de stamceltransplantatie of 1 jaar na laatste azacitidine in geval er geen stamceltransplantatie is gegeven.
    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 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 Yes
    E.7.1.3.1Other trial type description
    Phase I-II
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    historische data betreffende tijd tot transplantatie indien niet overbrugd met chemotherapie
    historical data when time to transplant was not bridged with chemotherapy
    E.8.2.4Number of treatment arms in the trial4
    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 EEA15
    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 No
    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
    Last patient last visit
    Laatste patiënt laatste visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    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.1.1Number of subjects for this age range: 12
    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: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    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) 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 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
    children 1 month of age until children 12 years of age
    Kinderen vanaf 1 maand tot 12 jaar
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    follow up (safety, survival, and new therapy) until 1 year after HSCT or last treatment in case HSCT did not take place.
    Follow up (veligheid, overleving en nieuwe therapy) tot 1 jaar na stamceltransplantatie of laatste gift indien er geen stamceltransplantatie is gegeven.
    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 ITCC
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation DCOG-ECTC
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation EWOG-MDS
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-12
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