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    EudraCT Number:2013-000390-70
    Sponsor's Protocol Code Number:DACOGENAML2004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-22
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-000390-70
    A.3Full title of the trial
    Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia.
    Estudio de fase I-II sobre la seguridad y la eficacia de DACOGEN en administración secuencial con citarabina en niños con leucemia mieloide aguda recidivante o resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia.
    Estudio de seguridad y eficacia de DACOGEN en administración secuencial con citarabina en niños con leucemia mieloide aguda recidivante o resistente al tratamiento
    A.4.1Sponsor's protocol code numberDACOGENAML2004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/225/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29-2333CM
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number34918062000
    B.5.5Fax number+31(0)715242110
    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. name DACOGEN
    D. of the Marketing Authorisation holderJanssen-Cilag International NV
    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/3/06/370
    D.3 Description of the IMP
    D.3.1Product nameDacogen
    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 INNDECITABINE
    D.3.9.1CAS number 2353-33-5
    D.3.9.4EV Substance CodeSUB06932MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 or Refractory Acute Myeloid Leukemia
    Leucemia mieloide aguda recidivante o resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Cancer of White Blood Cells
    Cancer de globulos blancos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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
    The primary objectives of the Phase 1 portion of Study DACOGENAML2004 are:
    ?to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2 per day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2 per day on Days 1-5 of a 28-day cycle.
    ?to determine PK parameters including maximum plasma concentration (Cmax), Area under the concentration x time curve (AUC), time to maximum plasma concentration (tmax), and clearance (Cl) of decitabine on Day 5 of Cycle 1.
    The primary objective of the Phase 2 portion of Study DACOGENAML2004 is to determine the response rate (CR + CRi) in children with relapsed or refractory AML when treated with DACOGEN 20 mg/m2 per day on Days 1-5 followed by cytarabine at the determined MTD on Days 8-12 for up to 4 cycles of treatment.
    Los objetivos principales de la parte de fase I del estudio DACOGENAML2004 son los siguientes:
    ? Determinar la dosis maxima tolerable (DMT) de citarabina (hasta 2 g/m2 al dia x 5) que puede administrarse en los dias 8-12, despues del tratamiento con 20 mg/m2 de DACOGEN al dia en los dias 1-5 de un ciclo de 28 dias.
    ? Determinar los parametros FC como la concentracion plasmatica maxima (Cmax), el area bajo la curva de concentracion-tiempo (ABC), el tiempo hasta alcanzar la concentración plasmatica maxima (tmax) y el aclaramiento (Acl) de decitabina el dia 5 del ciclo 1.
    El objetivo principal de la parte de fase II del estudio DACOGENAML2004 consiste en determinar la tasa de respuesta (RC + RCi) en niños con LMA recidivante o resistente al tratamiento, cuando reciben 20 mg/m2 de DACOGEN al dia en los dias 1-5, seguido de citarabina en la DMT determinada en los dias 8-12, hasta un maximo de 4 ciclos de tratamiento.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the safety profile of DACOGEN 20 mg/m2 per day administered on Days 1 to 5 allowed by cytarabine on Days 8 to 12 for up to 4 cycles of therapy and to describe the duration of CR + CRi and evaluate the overall response (CR + CRi + PR) to treatment.
    Los objetivos secundarios consisten en evaluar el perfil de seguridad de 20 mg/m2 de DACOGEN al día administrados en los dias 1 a 5, seguidos de citarabina en los dias 8 a 12 hasta un maximo de 4 ciclos de tratamiento y describir la duracion de la RC + RCi, asi como evaluar la respuesta general (RC + RCi + RP) al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histological diagnosis of acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification
    - Diagnosis of AML which has relapsed or is refractory to standard of care and no curative therapy exists
    - Karnofsky or Lansky score of at least 50
    - Must be recovered from acute toxicity of any prior treatment
    - Must have adequate organ function according to protocol-defined
    - Agrees to protocol-defined use of effective contraception
    - Female participants of childbearing potential must have a negative serum or urine pregnancy test at Day 1 of Cycle 1
    - Female participants must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
    - Male participants must not donate sperm during the study and for 3 months after receiving the last dose of study drug.
    El sujeto debe tener un diagnostico histologico de LMA de acuerdo con la clasificacion de la OMS.
    -El sujeto debe padecer LMA recidivante o resistente al tratamiento estandar, sin tratamiento curativo existente
    -El sujeto debe tener una puntuacion de Karnofsky o Lansky de como minimo 50
    -El sujeto debe estar recuperado de la toxicidad aguda de cualquier tratamiento anterior.
    -El sujeto debe tener una funcionalidad organica adecuada, definida en el protocolo
    - El sujeto esta de acuerdo en usar los metodos contraceptivos definidos en el protocolo
    -Las participantes deben comprometerse a no donar óvulos para reproducción asistida.
    - Los participantes masculinos deben comprometerse a no donar esperma durante el estudio y durante los 3 meses posteriores a la recepcion de la ultima dosis del farmaco del estudio.
    E.4Principal exclusion criteria
    - Prior treatment with decitabine or azacitidine
    - Acute promyelocytic leukemia (M3 subtype in the French-American-British [FAB] classification system)
    - Symptomatic central nervous system involvement of acute myeloid leukemia (AML)
    - AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome or Diamond-Blackfan anemia, or bone marrow failure associated with inherited syndromes
    - White blood cell count greater than 40,000 cells/mL
    - Known allergies, hypersensitivity, or intolerance to decitabine or cytarabine or their excipients
    - Contraindications to the use of cytarabine per local prescribing information or prior adverse reactions to cytarabine which would prevent further use
    - Currently enrolled in an interventional investigational study
    - Female who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study drug (however, the period after which it becomes safe to become pregnant after the last dose of treatment is not known)
    - Male who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
    - Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
    - Any social or medical condition that in the investigator?s opinion renders the participant unfit for study participation
    - History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease
    -History of human immunodeficiency virus (HIV) antibody positive
    -El sujeto ha recibido un tratamiento anterior con DACOGEN o azacitidina (Vidaza).
    -El sujeto tiene leucemia promielocitica aguda (subtipo M3 segun el sistema de clasificacion frances-americano-britanico [FAB]).
    -El sujeto presenta afectación sintomatica del sistema nervioso central en su LMA
    -El sujeto presenta LMA asociada a sindromes congenitos tales como el sindrome de Down, la anemia de Fanconi, el síndrome de Bloom, el sindrome de Kostmann o la anemia de Diamond-Blackfan, o insuficiencia medular asociada a sindromes hereditarios.
    -El sujeto presenta un recuento de leucocitos superior a 40.000 celulas/ml
    -El sujeto presenta alergia, hipersensibilidad o intolerancia a DACOGEN, citarabina o sus excipientes
    -El sujeto presenta alguna de las contraindicaciones de uso de citarabina segun la informacion de prescripción local o anteriormente ha sufrido reacciones adversas a citarabina que evitarian su uso posterior.
    - El sujeto esta inscrito actualmente en un estudio de investigación intervencionista
    -El sujeto es una mujer embarazada en periodo de lactancia o tiene previsto quedarse embarazada mientras este inscrita en el estudio, o en los 3 meses posteriores a la administracion de la última dosis del farmaco del estudio. Sin embargo, se desconoce el periodo que debe pasar despues de la ultima dosis del tratamiento antes que vuelva a ser seguro un embarazo
    -El sujeto es un hombre que tiene previsto tener hijos mientras este inscrito en este estudio o en los 3 meses posteriores a la administracion de la ultima dosis del farmaco del estudio
    -El sujeto presenta cualquier afeccion que, en opinion del investigador, hiciese que la participación no supusiese un beneficio para el sujeto o pudiera impedir, limitar o confundir las evaluaciones especificadas en el protocolo
    -El sujeto presenta una afección medica o de tipo social que, en opinion del investigador, hace que dicho sujeto no sea apto para la participacion en el estudio
    -El sujeto tiene antecedentes positivos del antigeno de superficie de la hepatitis B (HBsAg) o del anticuerpo contra la hepatitis C (anti-VHC) u otro tipo de hepatopatias activas clinicamente.
    -El sujeto presenta antecedentes de anticuerpos positivos frente al virus de la inmunodeficiencia humana (VIH).
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    For the Phase 1 portion of the study the primary endpoint will be DLT in the determination of the MTD (up to 2 g/m2 per day) of cytarabine given on Days 8 to 12 following the administration of DACOGEN at 20 mg/m2 on Days 1 to 5. DLTs are defined as the following
    ? Hematological DLT will be defined as failure to recover to an absolute neutrophil count (ANC) of 0.5 x 109/L (common terminology criteria for adverse events [CTCAE] Grade
    3) and non-transfusion dependent platelet count of 25 x 109/L (CTCAE Grade 3) due to documented bone marrow aplasia/hypoplasia (malignant infiltration or other cause excluded), by Day 42. Bone marrow aplasia/hypoplasia is defined as overall marrow cellularity less than 25%.
    ?Non-hematological DLT is defined as: any Grade ?3 toxicity possibly, probably or definitely related to study drug that persists for >5 days; any Grade 2 toxicity that persists for >7 days and that is intolerable to the patient.

    Phase 2:
    In the Phase 2 portion of this study the primary end point will be the CR +CRi rate as determined using IWG criteria. The response status of each patient will be determined prior to each cycle of DACOGEN + cytarabine after the first cycle. The best response up to 4 cycles of DACOGEN + cytarabine for each subject will be used to determine the rate of CR + CRi.

    Please refer to Page 40 & 41 of Protocol.
    Fase I:
    En la parte de fase I del estudio, el criterio de valoracion principal sera la TLD en la determinacion de la DMT (hasta 2 g/m2 al dia) de citarabina administrada en los dias 8 a 12 tras la administracion de 20 mg/m2 de DACOGEN en los dias 1 a 5. Las TLD se definen del modo siguiente:
    ?La TLD hematologica se define como la falta de recuperacion del recuento absoluto de neutrofilos (RAN) hasta un valor de 0,5 x 109/l (grado 3 de los criterios terminologicos comunes para acontecimientos adversos [CTCAA]) y un recuento de trombocitos no dependiente de transfusion de 25 x 109/l (CTCAA grado 3) a causa de aplasia o hipoplasia medular documentada (se excluye la infiltracion maligna o por otras causas) para el día 42. La aplasia o hipoplasia medular se define por una celularidad medular general inferior al 25 %.
    ?La TLD no hematologica se define por: cualquier toxicidad de grado ?3 posible, probable o definitivamente relacionada con el farmaco del estudio con una duracion >5 dias o cualquier toxicidad de grado 2 con una duración >7 dias intolerable para el paciente.

    Fase 2

    En la parte de fase II de este estudio, el criterio de valoracion principal sera la tasa de RC + RCi segun lo determinado por los criterios del GIT. El estado de respuesta de cada paciente se determinara antes de cada ciclo de DACOGEN + citarabina despues del primer ciclo. Se utilizara la mejor respuesta de hasta 4 ciclos de DACOGEN + citarabina de cada sujeto para determinar la tasa de RC + RCi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 4 cycles of treatment.
    Hasta 4 ciclos de tratamiento
    E.5.2Secondary end point(s)
    ? Safety profile of DACOGEN 20 mg/m2 per day on Days 1-5 followed by cytarabine Days 8-12 for up to 4 cycles of therapy.
    ? Duration of CR + CRi
    ? Overall response (CR + CRi + PR)
    ? Event-free survival (EFS), defined as the time from first dose of study drug to relapse from CR, death, or second malignancy for subjects who achieve CR; subjects who do not achieve CR will be considered to have an event on the day of the first dose of study drug. Other alternative EFS definitions may be considered.
    ?Overall survival
    ?To determine the PK profile of DACOGEN in children with AML

    Other Secondary Endpoints:
    ?To explore pharmacodynamic effects of DACOGEN with respect to DNA
    hypomethylation status and gene expression
    ?To explore predictive markers for response to DACOGEN.
    ? Levels of DACOGEN in the CSF if samples are collected as part of other required medical care.
    ?Perfil de seguridad de 20 mg/m2 de DACOGEN al dia los dias 1-5 seguido de citarabina los dias 8-12 durante un maximo de 4 ciclos de tratamiento.
    ?Duracion de la RC + RCi.
    ?Respuesta general (RC + RCi + RP).
    ?Supervivencia sin acontecimientos (SSA), definida como el tiempo desde la primera dosis del farmaco del estudio hasta la recaida de una RC, muerte o una segunda neoplasia en aquellos sujetos que logren la RC. En aquellos sujetos que no logren la RC se considerara que presentan un acontecimiento el dia de la primera dosis del farmaco del estudio. Podran considerarse otras definiciones alternativas de SSA.
    ?Supervivencia general.
    ?Determinar el perfil FC de DACOGEN en niños con LMA.

    Otros criterios de valoracion secundarios
    ?Explorar los efectos farmacodinamicos de DACOGEN con respecto al estado de hipometilación del ADN y la expresion genica.
    ?Explorar los marcadores predictivos de la respuesta a DACOGEN.
    ?Niveles de DACOGEN en el LCR si las muestras se recogen como parte de otra atencion medica necesaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time of progression/relapse, withdrawal, or death, for up to 3 years after last participant enrolment.
    Tiempo de progresion/recaida, retirada o muerte, para un maximo de 3 años despues de la inclusion del ultimo participante
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    Phase 1-2 Safety and Efficacy Study
    Esudio Fase 1-2 de seguridad y eficacia
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 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 EEA18
    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 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
    Ultima vista del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 33
    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. of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 12
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 33
    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 End of Treatment Visit should occur 30 days after the last dose of single agent DACOGEN after which the subjects will enter the Follow-up Phase of the study. In the event subjects continue to derive benefit at study end, DACOGEN will continue to be supplied by the Company.
    La visita de fin del tratamiento debera tener lugar 30 dias despues de la ultima dosis de DACOGEN como farmaco unico, tras la que el sujeto entrara en la fase de seguimiento del estudio. En caso de que los sujetos continuen obteniendo beneficios al final del estudio, la empresa seguira suministrando DACOGEN.
    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 Decision2014-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-28
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