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    Summary
    EudraCT Number:2018-001588-22
    Sponsor's Protocol Code Number:AML003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-001588-22
    A.3Full title of the trial
    Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥60 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML)
    Ensayo multicéntrico en fase III, no enmascarado, aleatorizado, para evaluar la eficacia y la seguridad de CPI-613 en combinación con dosis altas de citarabina y
    mitoxantrona (CHAM) comparado con dosis altas de citarabina y mitoxantrona
    (HAM) en pacientes de edad avanzada (> o = 60 años) con leucemia mieloide aguda
    (LMA) en recaída o refractaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical study to determine the efficacy and safety of CPI-613 in combination with high dose Cytarabine and Mitoxantrone compared to high dose Cytarabine and Mitoxantrone in adults with a type of cancer called acute myeloid leukemia
    Un estudio clínico fase III para determinar la eficacia y la seguridad de CPI-613 en
    combinación con altas dosis de citarabina y de mitoxantrona comparándolo con la
    administración de solo altas dosis de citarabina y mitoxantrona en adultos con un
    tipo de cáncer llamado leucemia mieloide aguda
    A.3.2Name or abbreviated title of the trial where available
    ARMADA 2000
    A.4.1Sponsor's protocol code numberAML003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03504410
    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 SponsorRafael Pharmaceuticals, 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 supportRafael Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRafael Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1 Duncan Drive
    B.5.3.2Town/ cityCranbury
    B.5.3.3Post codeNJ 08512
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3496 1244925
    B.5.6E-mailsanjeev.luther@rafaelpharma.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2123
    D.3 Description of the IMP
    D.3.1Product nameCPI-613
    D.3.2Product code CPI-613
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdevimistat (Rafael Pharmaceuticals)
    D.3.9.1CAS number 95809-78-2
    D.3.9.2Current sponsor codeCPI-613
    D.3.9.3Other descriptive name6,8-BIS(BENZYLTHIO)OCTANOIC ACID
    D.3.9.4EV Substance CodeSUB187819
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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.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 No
    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/3/18/2123
    D.3 Description of the IMP
    D.3.1Product nameCPI-613
    D.3.2Product code CPI-613
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdevimistat (Rafael Pharmaceuticals)
    D.3.9.1CAS number 95809-78-2
    D.3.9.2Current sponsor codeCPI-613
    D.3.9.3Other descriptive name6,8-BIS(BENZYLTHIO)OCTANOIC ACID
    D.3.9.4EV Substance CodeSUB187819
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Citarabina
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Oncology Plc.
    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.3.1Product nameCytarabine
    D.3.2Product code Cytarabine
    D.3.4Pharmaceutical form Solution for injection/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 INNCytarabine
    D.3.9.1CAS number 69-74-9
    D.3.9.3Other descriptive nameCYTARABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13523MIG
    D.3.10 Strength
    D.3.10.1Concentration unit gm/m2 gram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Mitoxantrone
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMitoxantrone
    D.3.2Product code Mitoxantrone
    D.3.4Pharmaceutical form 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 INNmitoxantrone
    D.3.9.1CAS number 65271-80-9
    D.3.9.3Other descriptive nameMITOXANTRONE
    D.3.9.4EV Substance CodeSUB09012MIG
    D.3.10 Strength
    D.3.10.1Concentration unit gm/m2 gram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Acute Myeloid Leukemia
    Leucemia mieloide aguda
    E.1.1.1Medical condition in easily understood language
    A blood cancer called Acute Myeloid Leukemia
    Un tipo de cáncer llamado leucemia mieloide aguda
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine efficacy of CHAM in terms of complete remission (CR) and compare with HAM (control). CR will be determined as per standard response criteria for AML (Döhner et al. 2010; 115[3]:453-474).
    Determinar la eficacia de CHAM en términos de remisión completa (RC) y comparar con HAM (control). La RC se determinará según los criterios de respuesta estándar para la LMA (Döhner et al. 2010; 115[3]:453-474).
    E.2.2Secondary objectives of the trial
    1. To determine efficacy of CHAM in terms of overall survival (OS) and complete remission with partial hematologic recovery (CRh) as the two key secondary objectives to compare with HAM (control). The OS and CRh will be determined as per standard response criteria for AML (Döhner et al. 2010; 115[3]:453-474).
    2. Safety: The assessment of safety will be based mainly on the frequency of adverse events (AEs) based on the Common Terminology Criteria for AEs (version 5.0 or later) grade. Adverse events will be coded according to the Medical Dictionary for Regulatory Activities. The safety outcomes will include the occurrence of at least one serious AE, of at least one Grade 3/4 AE, and of at least one AE requiring the discontinuation of study treatment. Electrocardiogram QTc intervals will also be evaluated.
    1. Determinar la eficacia de CHAM en términos de supervivencia general (SG) y
    remisión completa con recuperación hematológica parcial (RCh) como los dos
    objetivos secundarios clave para comparar con HAM (control). La SG y la RCh se
    determinarán según los criterios de respuesta estándar para la LMA (Döhner et al.
    2010; 115[3]:453-474). 2. Seguridad: La evaluación de la seguridad se basará
    principalmente en la frecuencia de los acontecimientos adversos (AA) según el
    grado de los Criterios terminológicos comunes para AA (v5.0 o posterior). Los
    acontecimientos adversos se codificarán según el Diccionario Médico para
    Actividades Reguladoras (MedRA). Los resultados de seguridad incluirán la
    aparición de al menos un AA grave, de al menos un AA de grado 3/4 y de al menos
    un AA que requiera la interrupción del tratamiento del estudio. También se
    evaluarán los intervalos QTc del electrocardiograma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females age ≥ 60 years must have histologically documented AML that is relapsed from, or refractory to, prior standard therapies.
    2. Refractory is defined as failure to achieve CR or complete remission with incomplete recovery (CRi) following:
    -Two standard dose Cytarabine based induction cycles or one High Dose Cytarabine (HiDAC) based cycle, or
    -Failure to respond to one cycle of either standard dose or HiDAC; defined as no decrease in marrow blast percentage from diagnosis on Day 14 marrow), or
    -No response after at least 3 cycles of a hypomethylating agent (azacytidine or decitabine).
    3. Relapse is defined as development of recurrent AML (Döhner et al. 2010; 115[3]:453-474) after CR or CRi has been achieved with a prior chemotherapy or after disease progression on a hypomethylating agent.
    4. ECOG PS (performance score) 0-2.
    5. Expected survival >3 months.
    1. Los hombres y mujeres con edad superior o igual a los 60 años tienen que haber
    documentado histológicamente LMA en la que se haya recaído o que se haya
    resistido antes de los tratamientos estándar. 2. Resistirse quiere decir que no se ha
    conseguido RC ni se ha completado la remisión, de manera que se produce una
    recuperación incompleta (RCi) después de lo siguiente: - dos dosis estándar de
    ciclos de inducción con citarabina o un ciclo con una dosis alta de citarabina
    (HiDAC), - no se responde a un ciclo de la dosis estándar o HiDAC; es decir, un
    aumento en el porcentaje de médula según el diagnóstico de la médula el día 14), -
    no hay respuesta después de 3 ciclos con un fármaco hipometilante (azacitidina o
    decitabina). 3. La recaída quiere decir que se ha desarrollado la LMA recurrente (Döhner et al. 2010; 115[3]:453-474) después de que RC o RCi se haya conseguido
    con una quimioterapia previa o después de una evolución de la enfermedad con un
    fármaco hipometilante. 4. EG ECOG (puntuación del estado general) 0-2. 5.
    Supervivencia prevista de más de 3 meses.
    E.4Principal exclusion criteria
    1. Patients who have received previous cytotoxic chemotherapy treatment for their relapsed or refractory AML. Previous treatment with hypomethylating agents (decitabine or azacytidine) either alone or in combination with Venetoclax is allowed. Targeted therapies including FLT3 or IDH1/2 inhibitors or Hydrea are allowed. Targeted therapies and Hydrea may be taken until the day prior to starting CHAM or HAM therapy.
    2. Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of CHAM or HAM therapy (the teratogenic potential of CPI-613 is unknown). Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at Screening.
    3. Patients receiving any other standard or investigational treatment for AML, or any other investigational agent for any indication within the past 2 weeks prior to initiation of CPI-613 treatment (the use of Hydrea and/or oral tyrosine kinase inhibitors FLT3 or IDH 1/2 inhibitors is allowed until the day prior to starting CHAM or HAM therapy). Previous exposure to a hypomethylating agent either alone or in combination with Venetoclax is allowed.
    4. Patients who have received immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment.
    5. Requirement for immediate palliative treatment of any kind including minor surgery.
    6. Patients who have received a chemotherapy regimen with autologous stem cell support (bone marrow transplantation) within 6 months of starting CHAM or HAM therapy.
    7. Patients who have had allogenic bone marrow transplantation.
    1. Pacientes que hayan recibido un tratamiento previo de quimioterapia citotóxica
    por su LMA que se resiste o que recae. Está permitido el tratamiento previo con
    fármacos hipometilantes (decitabina o azacitidina) individualmente o en
    combinación con venetoclax. Están permitidos los tratamientos dirigidos como los
    inhibidores FLT3 o IDH1/2 o Hydrea. Los tratamientos dirigidos y Hydrea se pueden
    tomar hasta el día antes de comenzar el tratamiento con CHAM o HAM. 2. Las
    pacientes que estén embarazadas, que estén amamantando o que estén
    planeando quedarse embarazadas durante el tratamiento y por un periodoadicional
    de 6 meses después de la última dosis del tratamiento con CHAM o HAM (el
    potencial teratogénico de CPI-613 se desconoce). Las pacientes en edad fértil con
    un test de embarazo positivo que se ha evaluado con un test de embarazo en suero
    en la selección. 3. Los pacientes que reciben cualquier otro tratamiento en
    investigación o estándar para la LMA o cualquier otro fármaco en investigación para
    cualquier indicación en las dos últimas semanas antes del tratamiento de CPI-613
    (el uso de Hydrea y de los inhibidores de la tirosina quinasa oral FLT3 o los
    inhibidores IDH 1/2 se permite hasta el día anterior al inicio del tratamiento con
    CHAM o HAM). Está permitida la exposición previa a un fármaco hipometilante, ya
    sea en monoterapia o en combinación con venetoclax. 4. Los pacientes que han
    recibido inmunoterapia de cualquier tipo, en las últimas 2 semanas antes del inicio
    del tratamiento de CPI-613. 5. Necesidad de tratamiento paliativo inmediato de
    cualquier tipo, incluida la cirugía menor. 6. Los pacientes que han recibido una
    pauta de quimioterapia con apoyo de autotrasplante de células madre (trasplante
    de médula ósea) dentro de los 6 meses de iniciar el tratamiento con CHAM o HAM.
    7. Los pacientes que hayan tenido un trasplante alogénico de médula ósea.
    E.5 End points
    E.5.1Primary end point(s)
    CR (Complete Remission).
    RC (Remisión completa)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1st Interim Analysis, 2nd Interim Analysis and Final Analysis
    Primer análisis intermedio, segundo análisis intermedio y análisis final
    E.5.2Secondary end point(s)
    1. OS (key secondary)
    2. CRh (key secondary)
    3. Safety
    4. PK
    5. PRO by EORTC QLQ C30
    6. Cancer-associated mutations and/or genetic alterations in bone marrow aspirate/biopsy and/or peripheral blood.
    1. SG (secundario clave) 2. Remisión completa con recuperación hematológica
    parcial (secundario clave) 3. Seguridad 4. Farmacocinética 5. Resultados
    informados por los pacientes mediante cuestionario EORTC QLQ C30 6.
    Mutaciones asociadas al cáncer y / o alteraciones genéticas en el aspirado / biopsia
    de médula ósea y / o sangre periférica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Final del estudio
    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 No
    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 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
    Cytarabine, Mitoxantrone
    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 EEA48
    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
    Belgium
    Canada
    France
    Germany
    Italy
    Korea, Republic of
    Poland
    Spain
    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
    LVLS
    Última visita del último 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    F.4.2.2In the whole clinical trial 500
    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)
    None
    Ninguno
    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 Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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