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    EudraCT Number:2016-001061-83
    Sponsor's Protocol Code Number:2215-CL-0304
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-001061-83
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML
    Ensayo de fase III, multicéntrico, aleatorizado, en doble ciego y controlado con placebo de gilteritinib, un inhibidor de FLT3, administrado como tratamiento de mantenimiento después de un alotrasplante, en pacientes con leucemia mieloide aguda con FLT3/ITD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This multi center Phase III clinical trial will evaluate impact of maintenance therapy (maintain the response achieved during the first course of treatment) with the FLT3 (FMS-like tyrosine kinase 3) inhibitor gilteritinib on the RFS (Relapse free survival) of participants with FLT3/ITD AML (FMS-like tyrosine kinase 3 / Internal tandem duplication Acute myeloid leukemia) who have successfully undergone allogeneic transplant.
    Este ensayo clínico de Fase III, multicéntrico, va a evaluar el impacto del tratamiento de mantenimiento (para mantener la respuesta alcanzada durante el primer ciclo de tratamiento) con gilterinib, un inhibidor de la FLT3 (FMS-like tyrosine kinase 3), sobre la RFS (relapse free survival) de participantes con leucemia mieloide aguda con FLT3/ITD (FMS-like tyrosine kinase 3 / Internal tandem duplication) que han sido sometidos con éxito a un alotrasplante en este estudio.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number2215-CL-0304
    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 SponsorAstellas Pharma Global Development, Inc.
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.4Telephone number+31715455878
    B.5.5Fax number+31715455224
    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 namegilteritinib
    D.3.2Product code ASP2215
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgilteritinib
    D.3.9.1CAS number ASP2215
    D.3.9.4EV Substance CodeSUB177203
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) (FLT3/ITD) acute myeloid leukemia (AML) in first morphologic complete remission (CR1) that has been treated with allogeneic hematopoietic stem cell transplant (HCT)
    Tirosina-cinasa similar a FMS 3(FLT3) /Duplicación en tándem interna(ITD), (FLT3/ITD) Leucemia mieloide aguda (AML) Primera remisión morfológica complete (CR1) que ha sido tratada con Hematopoietic stem cell transplant(HCT)
    E.1.1.1Medical condition in easily understood language
    AML is cancer of myeloid line of blood cells characterized by rapid growth of abnormal white blood cells that accumulate in bone marrow and interfere with production of normal blood cells
    AML es un cáncer mieloide de las cel sanguineas con un rápido crecimiento de leucocitos anormales que se acumulan en la médula ósea e interfieren en la producción de células sanguineas normales
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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 objective is to compare relapse-free survival (RFS) between participants with FLT3/ITD AML in CR1 who undergo HCT and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period
    El objetivo principal es comparar la supervivencia sin recidiva entre los participantes con leucemia mieloide aguda y FLT3/ITD en primera remisión morfológica completa sometidos a un alotrasplante de progenitores hematopoyéticos y aleatorizados a recibir gilteritinib o placebo después del prendimiento del injerto durante un periodo de dos años.
    E.2.2Secondary objectives of the trial
    1.To determine the safety and tolerability of gilteritinib after HCT.
    2.To compare overall survival (OS), non-relapse mortality (NRM) and event-free survival (EFS) (where events include relapse, death, stopping therapy and administration of donor lymphocyte infusion (DLI) or new therapy for suspicion of disease) in participants treated with gilteritinib as maintenance therapy after HCT compared to those treated with placebo.
    3.To compare 6-month cumulative incidence of grades II-IV and III-IV acute graft-versus host disease (GVHD) and 12-month and 24-month cumulative incidence of mild, moderate, and severe GVHD in participants treated with gilteritinib as maintenance therapy after HCT compared to those treated with placebo.
    4.To examine the effect of pre- and post-transplant MRD on RFS and OS.
    1.Determinar la seguridad y la tolerabilidad del gilteritinib después del trasplante de progenitores hematopoyéticos.
    2.Comparar la supervivencia global, la mortalidad sin recidiva y la supervivencia sin acontecimientos (los acontecimientos incluyen recidiva, muerte, suspensión del tratamiento y administración de una infusión de linfocitos de donante o un nuevo tratamiento por sospecha de enfermedad) en participantes tratados con gilteritinib como tratamiento de mantenimiento después del trasplante, frente a los tratados con placebo.
    3.Comparar la incidencia acumulada a los 6 meses de enfermedad de injerto contra huésped aguda de grados II-IV y III-IV, y la incidencia acumulada a los 12 y a los 24 meses de enfermedad de injerto contra huésped leve, moderada y severa, en los participantes tratados con gilteritinib como tratamiento de mantenimiento después del trasplante, frente a los tratados con placebo.
    4.Vease synopsis del protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is suitable candidate for HCT and has an acceptable source of allogeneic donor stem cells, as defined per institutional practice (allogeneic HCT for any donor source [matched sibling, unrelated donor (URD), mismatched URD, related haploidentical, or umbilical cord blood] and any graft source [umbilical cord, BM, peripheral blood (PB)], and any conditioning [myeloablative conditioning (MAC), reduced intensity conditioning (RIC), or non-myeloablative conditioning (NMA)] will be permitted).
    2.IRB/IEC approved written ICF and privacy language obtained from the participant or legally authorized representative prior to any study-related procedures
    3.Subject is legal adult by local regulation at the time of signing ICF
    4.Subject consents to allow access to his or her diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available.
    5.Subject has confirmed, morphologically documented AML in CR1. For the purposes of registration, CR1 will be defined as < 5% blasts in the BM with no morphologic characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
    a.Subject has not received more than 2 cycles of induction chemotherapy to achieve CR1.
    b.Subjects with CR with incomplete count recovery (CRp or CRi) are allowed. Incomplete platelet recovery (CRp) is defined as CR with platelet count < 100 x 109/L. Incomplete hematologic recovery (CRi) is defined as CR with residual neutropenia < 1 x 109/L with or without complete platelet recovery. RBC and platelet transfusion independence is not required.
    c.The maximum time allowed from establishment of CR1 to registration is 12 months.
    6.Subject has presence of the FLT3/ITD activating mutation in the BM or PB as determined by the local institution at diagnosis.
    7.Subject must meet the following criteria as indicated on the clinical laboratory tests:
    a.Serum creatinine within normal range, or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125% of ideal body weight.
    b.Total bilirubin (TBL) ≤ 2.5 mg/dL, except for participants with Gilbert’s syndrome.
    c.Serum AST and/or alanine aminotransferase (ALT) < 3 x institutional upper limit of normal (ULN).
    d.Serum potassium and magnesium greater than the institutional lower limit of normal (LLN).
    8.Subject has left ventricular ejection fraction at rest ≥ 40%.
    9.Subject has diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC) > 50% predicted.

    For all Registration Inclusion Criteria, see protocol.
    For a list of Randomization Eligibility Criteria and Randomization Inclusion Criteria, see protocol.
    1. El sujeto es un candidato adecuado para un HCT y posee una fuente aceptable de células progenitoras de un donante alogénico, según su definición por el centro (se permite lo siguiente: HCT de cualquier tipo de donante [hermano/hermanastro compatible, donante no emparentado (unrelated donor, URD), URD no compatible, haploidéntico emparentado o sangre de cordón umbilical] y cualquier tipo de origen del trasplante [cordón umbilical, médula ósea, sangre periférica] y cualquier tipo de tratamiento acondicionante mieloablativo [(myeloablative conditioning, MAC), acondicionante de intensidad reducida (reduced intensity conditioning, RIC) o acondicionante no mieloablativo (non-myeloablative conditioning, NMA)].
    2. Obtención del DCI por escrito aprobado por el CEIm (y con un texto acerca de la privacidad), otorgado por el participante o su representante legalmente autorizado antes de la práctica de cualquier procedimiento del estudio
    3. En el momento de la firma del DCI, el sujeto es mayor de edad de acuerdo a la legislación local
    4. El sujeto otorga su consentimiento para permitir el acceso a su aspirado de médula ósea o muestra de sangre periférica y/o DNA procedente de dicha muestra mediante los que se formuló el diagnóstico (si se dispone de dicha muestra).
    5. El sujeto presenta una leucemia mieloide aguda morfológicamente documentada y confirmada, en CR1. A fines del registro, la CR1 se define como <5% de blastos en médula ósea, sin características morfológicas de leucemia aguda (esto es, cuerpos de Auer) en médula ósea y sin signos de enfermedad extramedular, como afectación de sistema nervioso central o sarcoma granulocítico.
    a. El sujeto ha recibido un máximo de dos números ciclos de quimioterapia de inducción para alcanzar la CR1.
    b. Se permiten los sujetos en CR con recuperación incompleta de los recuentos hematológicos (CRp o CRi). La recuperación incompleta de las plaquetas (CRp) se define como una CR con una cifra de plaquetas < 100 x 109/L. La recuperación hematológica incompleta (CRi) se define como una CR con neutropenia residual < 1 x 109/L, con o sin recuperación completa de las plaquetas. No se precisa la independencia de transfusiones de hematíes y plaquetas.
    c. El plazo máximo de tiempo permitido desde el establecimiento de la CR1 al registro es de 12 meses.
    6. El sujeto muestra la presencia de la mutación activadora FLT3/ITD en médula ósea o sangre periférica, de acuerdo al centro local en el momento del diagnóstico.
    7. El sujeto debe cumplir los siguientes criterios en las determinaciones de laboratorio:
    a. Creatinina sérica dentro de la normalidad o, en caso contrario, una tasa de filtración glomerular (glomerular filtration rate, GFR) > 40 mL/min/1,73m2 según la ecuación de Cockcroft-Gault, con ajuste en caso de peso corporal ≥ 125% del peso ideal.
    b. Bilirrubina total ≤ 2,5 mg/dL, excepto en los participantes con síndrome de Gilbert.
    c. Valores séricos de AST y/o ALT < 3 x límite superior de la normalidad del centro (upper limit of normal, ULN).
    d. Potasio y magnesio séricos por encima del límite inferior de la normalidad (lower limit of normal, LLN) del centro.
    8. Fracción de eyección de ventrículo izquierdo en reposo ≥ 40%.
    9. Capacidad de difusión del monóxido de carbono (DLCO) (corregida según la hemoglobina), volumen espiratorio forzado en 1 segundo (forced expiratory volume in 1 second, FEV1) y capacidad vital forzada (forced vital capacity, FVC) > 50% del teórico.

    Para un listado completo de los criterios de inclusión para el Registro, véase el protocolo.
    Para un listado completo de los criterios de elegibilidad para la Aleatorización y de los criterios de inclusión para la Aleatorización, véase el protocolo.
    E.4Principal exclusion criteria
    1.Participant has had a prior allogeneic transplant.
    2.Participant has Karnofsky performance status score < 70% (APPENDIX F).
    3.Participant requires treatment with concomitant drugs that are strong inducers of CYP3A4.
    4.Participant requires treatment with concomitant drugs that target serotonin 5 hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.
    5.Participant has a Fridericia-corrected QT interval (QTcF) > 450 msec (average of triplicate determinations).
    6.Participant has long QT Syndrome at screening.
    7.Participant has a known infection with human immunodeficiency virus (HIV) as determined by serology or nucleic acid amplification test (NAAT).
    8.Participant has active hepatitis B infection as determined by NAAT or surface antigen assay. Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible.
    9.Participant has active hepatitis C infection as determined by NAAT. Participants who have had past exposure and have no detectable virus either through spontaneous clearance or treatment are eligible.
    10.Participant with uncontrolled infections will be excluded. If a bacterial or viral infection is present, the participant must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to registration. If a fungal infection is present, the participant must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to registration.
    •Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection.
    •Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
    11.Participant has had a myocardial infarction within 6 months prior to registration or New York Heart Association (NYHA) Class III or IV heart failure (APPENDIX D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.

    For all Registration Exclusion Criteria, see protocol.
    For a list of Randomization Exclusion Criteria, see protocol
    1. El participante ha recibido un alotrasplante previo.
    2. El participante posee una puntuación del estado funcional de Karnofsky < 70% (Apéndice F).
    3. El participante precisa tratamiento concomitante con fármacos que son potentes inductores de la isoenzima CYP3A4.
    4. El participante precisa tratamiento concomitante con fármacos cuyo objetivo es el receptor serotoninérgico 1 de la 5-hidroxitriptamina (5HT1R) o el receptor serotoninérgico 2B de la 5-hidroxotriptamina (5HT2BR) o el receptor sigma inespecífico, con la excepción de aquellos fármacos que se consideren absolutamente esenciales para la atención médica del paciente.
    5. El participante tiene un intervalo QT con corrección de Fridericia (QTcF) > 450 mseg (como media de tres determinaciones).
    6. El participante muestra un síndrome de QT largo en la selección.
    7. El participante presenta infección por el virus de la inmunodeficiencia humana, determinada por serología o prueba de amplificación de ácido nucleico (nucleic acid amplification test, NAAT).
    8. El participante presenta una hepatitis B activa, determinada por NAAT o por la prueba del antígeno de superficie. Podrán participar los sujetos con inmunidad adquirida como consecuencia de una exposición anterior (positividad de HBcAb / negatividad de HBsAb negatividad de HBsAg) .
    9. El participante presenta una hepatitis C activa según la NAAT. Podrán participar los participantes que hayan tenido la infección en el pasado pero que no presenten virus detectable, ya sea por eliminación espontánea o como consecuencias del tratamiento oportuno.
    10. No podrán participar los sujetos con infecciones no controladas. En caso de infección bacteriana o vírica presente, el participante deberá estar recibiendo un tratamiento resolutivo y no podrá haber presentado signos de progresión de la infección en el plazo de las 72 horas previas al registro. En caso de infección fúngica presente, el participante deberá estar recibiendo un tratamiento antifúngico resolutivo y no podrá haber presentado signos de progresión de la infección en el plazo de la 1 semana previa al registro.
    • La infección en progresión se define como la inestabilidad hemodinámica atribuible a sepsis o la presencia de nuevos síntomas, empeoramiento de los signos físicos o de los hallazgos radiológicos de forma atribuible a la infección.
    •La fiebre persistente sin otros signos o síntomas no se interpretará como infección en progresión
    11. El participante ha sufrido un infarto en miocardio en los 6 meses previos al registro o presenta insuficiencia cardíaca de Clase III o IV de la New York Heart Association (NYHA) (Apéndice D), angina no controlada, arritmia ventricular severa no controlada o signos electrocardiográficos de isquemia aguda.

    Para un listado completo de los criterios de exclusión para el Registro, véase el protocolo.
    Para un listado completo de los criterios de exclusión para la Aleatorización, véase el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is RFS, treated as a time to event outcome. The primary analysis will be performed using the intent-to-treat principle so that all randomized participants will be included in the analysis. Leukemia relapse or death will be considered failures for this endpoint, which will be adjudicated by a blinded endpoint review committee.
    El criterio principal de la valoración es la RFS, valorada como el tiempo transcurrido hasta el acontecimiento. Para el análisis principal se utilizará el principio estadístico de intención de tratar, por lo que se incluirán en el análisis todos los participantes aleatorizados. La recidiva de la leucemia o la muerte se considerarán fracasos en cuanto a este criterio de valoración, que se someterá a clasificación por un comité de revisión desconocedor del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from randomization to either leukemia relapse or death, whichever comes first.
    El tiempo desde la aleatorización hasta la recaída de leucemia o la muerte, lo que ocurra primero
    E.5.2Secondary end point(s)
    Safety and tolerability
    Overall survival (OS)
    Non-relapse mortality
    Event-free survival (EFS)
    Cumulative incidence of acute graft-versus-host disease (GVHD)
    Cumulative incidence of chronic GVHD
    detection of minimal residual disease (MRD)
    Seguridad y tolerabilidad
    Supervivencia global (OS)
    Mortalidad sin recidiva
    Supervivencia sin acontecimientos (EFS)
    Incidencia acumulada de enfermedad de injerto contra huésped (GVHD)
    Incidencia acumulada de GVHD crónica
    Detención de enfermedad residual minima (MRD)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and tolerability - measured from randomization through 30 days after end of study drug.
    OS - measured from randomization to date of death from any cause.
    Non-relapse mortality - measured from randomization through death.
    EFS - measured at 12 and 24 months after randomization.
    Cumulative incidence of acute GVHD - measured from randomization through 6 months after randomization
    Cumulative incidence of chronic GVHD - measured from randomization through 12 and 24 months after randomization.
    Detection of MRD - measured from pre-HCT through 24 months after randomization.
    Seguridad y tolerabilidad - medida de aleatorización 30 días después del final del estudio.
    OS - medida desde la aleatorización hasta la fecha de la muerte por cualquier causa.
    Mortalidad sin recidiva - medida de aleatorización a través de la muerte.
    EFS - medido entre los 12 y 24 meses después de la aleatorización.
    Incidencia acumulada de enfermedad aguda de GVHD-medida desde la aleatorización hasta 6 meses después de la aleatorización
    Incidencia acumulada de enfermedad crónica de GVHD- medida de aleatorización de 12 y 24 meses después de la aleatorización.
    Detención de MRD - medida de pre-HCT durante 24 meses después de la aleatorización
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Korea, Republic of
    United Kingdom
    United States
    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
    End of trial is defined as last-patient-last-contact
    Final del ensayo se define como último contacto del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 850
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 1000
    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)
    All participants may remain on treatment for up to 2 years after randomization. After treatment discontinuation, long-term follow up for relapse and/or death will occur until 5 years after the last participant is randomized or until 80% of the relapse events have occurred, whichever comes first.
    Todos los participantes podrán permanecer en tratamiento hasta 2 años después de la aleatorización. Después de la discontinuación del tratamiento, el seguimiento a largo plazo para la recaída o muerte sera hasta 5 años después de que el último paciente sea aleatorizado o hasta que el 80% de los eventos de recidiva hayan sucedido, lo que primero suceda.
    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 Froedtert and the Medical College of Wisconsin Clinical Cancer Center CIBMTR® | Milwaukee Campus
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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