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    Summary
    EudraCT Number:2016-003900-30
    Sponsor's Protocol Code Number:M16-043
    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:2017-06-09
    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 number2016-003900-30
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
    Estudio aleatorizado doble ciego, y controlado con placebo de Venetoclax administrado con Citarabina a dosis bajas versus Citarabina a dosis bajas para el tratamiento de paciente naive con leucemia mieloide aguda que no son candidatos a quimioterapia intensiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
    Estudio de Venetoclax co-administrado con bajas dosis de Citarabina frente a bajas dosis de solo Citarabina en pacientes que no han sido tratados con Leucemia Mieloide Aguda que no son elegibles para tratamiento de quimioterapia intensiva.
    A.4.1Sponsor's protocol code numberM16-043
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901 20 01 03
    B.5.6E-mailabbvie_reec@abbvie.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    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 INNVenetoclax
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    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 INNVenetoclax
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    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.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 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 nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    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 INNVenetoclax
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    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
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Acute Myeloid Leukemia
    Leucemia Mieloide Aguda
    E.1.1.1Medical condition in easily understood language
    Cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells.
    Cáncer en la línea mieloide de células sanguíneas, caracterizado por el rápido crecimiento de glóbulos blancos anormales en médula ósea que interfieren en la producción de células sanguíneas normales
    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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if venetoclax when co-administered with low dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment naïve subjects with acute myeloid leukemia (AML).
    Determinar si venetoclax coadministrado con cytarabina a bajas dosis (LDAC) mejora la supervivencia global frente a LDAC con placebo en tratamiento en sujetos Naive con Leucemia mieloide aguda.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • To evaluate if venetoclax when co-administered with LDAC improves complete remission rate (complete remission + complete remission with incomplete marrow recovery, CR + CRi).
    • To evaluate if venetoclax when co-administered with LDAC improves event-free survival (EFS).
    • To evaluate if venetoclax when co-administered with LDAC improves the proportion of subjects achieving a composite CR (CR + CRi) by the end of Cycle 1.
    • To evaluate if venetoclax when co-administered with LDAC reduces fatigue based on patient reported outcome (PRO) assessment Patient Reported Outcomes Measurement Information System (PROMIS), Fatigue Short Form (SF) 7a.
    • To evaluate if venetoclax when co-administered with LDAC improves subjects Global Health Status/Quality of Life (GHS/QoL) based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30).
    Los objetivos secundarios del estudio son: • Determinar si venetoclax administrado con LDAC mejora el ratio de remision completa combinada. (Remisión completa + Remisión completa con recuperación incompleta del recuento sangúineo) • Determinar si venetoclax administrado con LDAC mejora la supervivencia si episodios. • Determinar si venetoclax administrado con LDAC mejora el porcentaje de pacientes que consiguen una CR combinada al final del ciclo 1. • Determinar si venetoclax administrado con LDAC disminuye el cansancio según lo determinado mediante los resultados comunicados por los pacientes, concretamente mediante el cuestionario abreviado SF 7a Cansancio del Sistema de Información para la Medición de Resultados Comunicados por los Pacientes.
    • Determinar si venetoclax coadministrado con LDAC mejora el estatus general de salud/calidad de vida basado en el cuestionario de calidad de vida QLQ-C30 de la organización Europea para la investigación y tratamiento del cáncer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for study participation if he/she meets the following criteria within 21 days prior to randomization.
    • Subject must have histological confirmation of AML by WHO criteria, is ineligible for intensive induction chemotherapy and either is:
    - ≥ 75 years of age
    OR
    - ≥ 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy:
    o Eastern Cooperative Oncology Group (ECOG) Performance status of 2 – 3
    o Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina
    o DLCO ≤ 65% or FEV1 ≤ 65%
    o Creatinine clearance ≥ 30 mL/min to < 45 ml/min
    o Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN
    o Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment
    • Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status:
    • of 0 to 2 for subjects ≥ 75 years of age OR
    • of 0 to 3 for subjects between 18 to 74 years of age
    • Subject must have a projected life expectancy of at least 12 weeks.
    • Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection.
    • Subject must have adequate liver function as demonstrated by:
    • aspartate aminotransferase (AST) ≤ 3.0 × ULN*
    • alanine aminotransferase (ALT) ≤ 3.0 × ULN*
    • bilirubin ≤ 1.5 × ULN*
    o Subjects who are < 75 years of age may have bilirubin of ≤ 3.0 × ULN
    * Unless considered to be due to leukemic organ involvement.
    • Female subjects must be either postmenopausal defined as:
    - Age > 55 years with no menses for 12 or more months without an alternative medical cause OR
    - Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L.
    OR
    - Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
    OR
    - A Woman of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
    • Male subjects who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
    • Females of childbearing potential must have negative results for pregnancy test performed:
    - At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
    - Prior to dosing with urine sample obtained on Week 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
    - Subject with borderline pregnancy tests at screening must have a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.
    • Subject must voluntarily sign and date an informed, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
    Un sujeto será apto para participar en el estudio si reúne los siguientes criterios 21 días antes de la randomización:
    1. El paciente tiene que tener confirmación histológica de LMA por los criterios de la OMS. No es elegible para inducción de quimioterapia intensiva y es:
    o ≥ 75 años
    o Tener entre 18 y 74 años de edad y cumplir al menos uno de los criterios de ausencia de idoneidad para la quimioterapia de inducción intensiva:
    • Estado Funcional del Eastern Cooperative Oncology Group (ECOG) de 2 a 3
    • Antecedentes de ICC con necesidad de tratamiento o fracción de eyección ≤ 50% o angina de pecho estable crónica
    • DLCO ≤ 65% o FEV1 ≤ 65%
    • Aclaramiento de creatinina ≥ 30 mL/min a < 45 ml/min
    • Insuficiencia hepática moderada con bilirrubina total > 1.5 a ≤ 3.0 × LSN
    • Cualquier otra enfermedad concomitante que el medico crea que es incompatible con la quimioterapia intensiva convencional debe ser revisada y aprobada por el monitor medical del estudio antes de inscribir al paciente en el estudio.

    2. Los pacientes deben presentar un ECOG:
    o De 0 a 2 para pacientes ≥ 75 años, o
    o DE 0 a 3 para pacientes entre 18 – 74 años

    3. Tener una esperanza de vida prevista de 12 semanas como mínimo
    4. El paciente tiene que tener una función renal adecuada con aclaramiento de creatinina≥ 30 mL/min; calculado con la fórmula de Cockcroft Gault o medido por recogida de orina de 24-hours.
    5. El paciente tiene que tener una función hepática adecuada con niveles de:
    o Aspartato Aminotransferasa (AST) ≤ 3.0 × ULN*
    o Alanina Aminotransferasa (ALT) ≤ 3.0 × ULN*
    o Bilirrubina ≤ 1.5 × ULN*
    • Sujetos que tienen < 75 años pueden tener bilirubina ≤ 3.0 × ULN * A menos que se considere debido a la afectación orgánica leucémica.
    6. Las mujeres debe ser posmenopáusicas cumpliendo los siguientes criterios:
    o Edad > 55 años sin menstruación durante 12 meses o más sin causa médica alternativa
    o Edad ≤ 55 años sin menstruación durante 12 meses o más sin una causa médica alternativa y niveles de FSH > 40 IU/L.
    O
    o Sometidas a esterilización quirúrgica (ovariectomía bilateral, salpingectomía bilateral o histerectomía)
    O
    o En el caso de mujeres en edad fertil (MEF), deberán utilizar al menos uno de los métodos anticonceptivos especificados en el protocolo desde día 1 del estudio y hasta al menos 180 días después de recibir la última dosis del fármaco del estudio.
    Los pacientes varones que sean sexualmente activos deben comprometerse, desde el día 1 del estudio hasta al menos 180 días después de la última dosis del medicamento del estudio, a utilizar métodos anticonceptivos especificados en el protocolo. Los varones que participen en el estudio deben comprometerse a no donar semen desde la administración inicial del fármaco del estudio hasta al menos 180 días después de la última dosis de dicho medicamento.
    7. Las mujeres en edad fértil deben tener resultados negativos en test de embarazo:
    o En la selección, con una muestra de suero 14 días antes de la primera administración.
    o Antes de la administración con una muestra de orina obtenida el día 1 de la semana 1 si han transcurrido más de 7 días desde la obtención de los resultados de la prueba de embarazo en suero.
    o En las pacientes con un resultado limítrofe en la prueba de embarazo de selección debe hacerse una prueba de embarazo en suero al menos 3 días después para documentar que se mantiene la ausencia de un resultado positivo.
    8. Los pacientes, voluntariamente, firmarán y fecharán el consentimiento informado aprobado por el CEIm, antes de la iniciación de cualquier procedimiento específico para la selección del estudio.
    E.4Principal exclusion criteria
    • Subject has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for Myelodysplastic Syndrome is allowed except for use of cytarabine.
    • Subject had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, olycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL mutation.
    • Subjects that have acute promyelocytic leukemia (APL).
    • Subject has known CNS involvement with AML.
    • Subject has known HIV infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax).
    • Subject is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded.
    • Subject has received strong or moderate CYP3A inducers 7 days prior to the initiation of study treatment.
    • Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.
    • Subject has cardiovascular disability status of New York Heart Association Class > 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain.
    • Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
    • Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
    • Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
    • Subject has a history of other malignancies prior to study entry, with the exception of:
    - Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
    - Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
    - Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
    • Subject has a white blood cell count > 25 × 109/L. (Note: Hydroxyurea administration or leukapheresis is permitted to meet this criterion).
    1. El paciente ha recibido con anterioridad algún tratamiento para la LMA con la excepción de hidroxiurea, que se permite durante el primer ciclo del tratamiento del estudio. Nota: se permite el tratamiento previo por síndrome mielodisplásico siempre que no incluyera citarabina.
    2. El paciente tiene antecedentes de neoplasia mieloproliferativa (NMP) como mielofibrosis, trombocitosis esencial, policitemia vera o leucemia mielógena crónica (LMC) con o sin mutación del gen BCR-ABL.
    3. El paciente presenta leucemia promielocítica aguda (LPA).
    4. El paciente presenta afectación confirmada del SNC por la LMA.
    5. El paciente presenta infección confirmada por el VIH (debido a las posibles interacciones farmacológicas entre los antirretrovirales y venetoclax).
    6. El paciente presenta infección confirmada por el virus de la hepatitis B (VHB) o C (VHC). No quedarán excluidos los pacientes portadores de hepatitis inactiva o con una viremia baja en tratamiento con antivirales (que no sean motivo de exclusión).
    7. El paciente ha recibido inductores fuertes o moderados de la CYP3A en los 7 días previos al comienzo del tratamiento del estudio.
    8. El paciente ha tomado pomelo, productos de pomelo, naranjas amargas (o mermelada de este tipo de naranjas) o carambola en los 3 días previos al comienzo del tratamiento del estudio.
    9. El paciente presenta un estado de discapacidad cardiovascular de clase 2 o superior de la New York Heart Association. La clase 2 se define como un trastorno cardíaco en el que el paciente se encuentra bien en reposo pero presenta cansancio, palpitaciones, disnea y dolor de tipo anginoso al realizar una actividad física normal.
    10. El paciente presenta una enfermedad respiratoria crónica que requiere oxígeno continuo o tiene antecedentes importantes de enfermedad renal, neurológica, psiquiátrica, endocrinológica, metabólica, inmunitaria, hepática o cardiovascular, o cualquier otra afección que en opinión del investigador pueda afectar de manera adversa a su participación en este estudio.
    11. El paciente tiene un síndrome de malabsorción u otro trastorno que impide la administración por vía enteral.
    12. El paciente presenta signos de otra infección sistémica (viral, bacteriana o fúngica) no controlada y clínicamente importante que requiere tratamiento.
    13. El paciente tiene antecedentes de otras neoplasias malignas antes de la inclusión en el estudio, con la excepción de:
    o Carcinoma in situ de cuello uterino o de mama tratado adecuadamente;
    o Carcinoma basocelular o espinocelular localizado de la piel;
    o Neoplasia maligna previa confinada y resecada quirúrgicamente (o tratada con otras modalidades) con intención curativa.
    14. El paciente tiene un recuento de leucocitos > 25 × 109/l. (Nota: se permite la administración de hidroxicarbamida o la leucaféresis para cumplir este criterio.)
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS)
    Supervivencia Global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured up to 2 years after the last participant is randomized
    Medido hasta 2 años después de que el último paciente sea aleatorizado
    E.5.2Secondary end point(s)
    - CR + CRi rate
    - Event-Free Survival (EFS);
    - CR + CRi rate by initiation of Cycle 2.
    - Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form [SF] 7a.
    - Global Health Status/Quality of Life (GHS/QoL) based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30)
    1. Tasa RC + RCi.
    2. Supervivencia sin episodios (SSE).
    3. Tasa RC + RCi al inicio del ciclo 2.
    4. Determinar el cansancio según el cuestionario abreviado SF 7a Cansancio del Sistema de Información para la Medición de Resultados Comunicados por los Pacientes (PROMIS)
    5. La salud general y la calidad de vida (ESG/CdV) según el cuestionario de calidad de vida QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - EFS: Measured up to 2 years after the last participant
    - CR +CRi rate: 6 months after the last participant is randomized
    - Fatigue based on the PROMIS Fatigue SF 7a: Measured up to 2 years after the last participant
    - GHS/QoL scale from the EORTC QLQ-C30: Measured up to 2 years after the last participant
    1. SSE: Medido hasta 2 años después del último participante
    2. Ratio RC + RCi: 6 meses después de que el último paciente haya sido aleatorizado
    3. el cansancio determinado según el cuestionario PROMIS SF 7: : Medido hasta 2 años después del último participante
    4. Escala ESG/CdV según el cuestionario de calidad de vida EORTC QLQ-C30: Medido hasta 2 años después del último 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker, Exploratory
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    European Union
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Norway
    Russian Federation
    South Africa
    Taiwan
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 155
    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 58
    F.4.2.2In the whole clinical trial 175
    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)
    After treatment discontinuation, subjects will be followed for, overall survival, progressive disease and post-therapy disease status (if applicable).
    Después de la discontinuación del tratamiento, se realizará un seguimiento de los sujetos de supervivencia global, progresión de la enfermedad y estado post-tratamiento (si aplica).
    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 Decision2017-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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