Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002851-14
    Sponsor's Protocol Code Number:QUIWI
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-03
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2018-002851-14
    A.3Full title of the trial
    A 2:1 randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type AML
    Estudo de fase II, com aleatorização na proporção de 2:1, para comparar a eficácia e segurança do tratamento com quimioterapia padrão mais Quizartinib em relação à quimioterapia padrão mais placebo em doentes adultos com diagnóstico de novo de Leucemia Mieloide Aguda (LMA) sem mutação no gene FLT3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CIinical trial to compare the efficacy and safety of chemotherapy plus quizartinib versus chemotherapy plus placebo in patients with acute myeloid leukemia without FLT3 mutation
    Ensaio clínico para comparar a a eficácia e segurança da quimioterapia mais Quizartinib em relação à quimioterapia mais placebo em doentes com leucemia mieloide aguda sem mutação no gene FLT3
    A.4.1Sponsor's protocol code numberQUIWI
    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 SponsorFUNDACIÓN PETHEMA
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDaiichi Sankyo Europe GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressC/ Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number+34914561105
    B.5.5Fax number+34914561126
    B.5.6E-mailf.gonzalez@dynasolutions.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 nameQuizartinib
    D.3.2Product code AC220
    D.3.4Pharmaceutical form 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 INNQuizartinib
    D.3.9.1CAS number 950769-58-1
    D.3.9.3Other descriptive nameQUIZARTINIB
    D.3.9.4EV Substance CodeSUB89721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 nameQuizartinib
    D.3.2Product code AC220
    D.3.4Pharmaceutical form 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 INNQuizartinib
    D.3.9.1CAS number 950769-58-1
    D.3.9.3Other descriptive nameQUIZARTINIB
    D.3.9.4EV Substance CodeSUB89721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboTablet
    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 placeboTablet
    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
    Acute myeloid leukemia
    Leucemia mieloide aguda
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    To compare the EFS rate (failure to achieve CR/CRi after 1 or 2 induction cycles, death in CR/CRi or relapse, whichever occurs the first) between the experimental quizartinib containing schedule and standard arms
    Comparar a taxa de sobrevivência livre de eventos (SLE) (falha na obtenção de remissão completa/remissão completa com recuperação hematológica incompleta (RC/RCi) após 1 ou 2 ciclos de indução, morte na RC/RCi ou recidiva, o que ocorrer primeiro) entre o grupo com o medicamento experimental Quizartinib e o grupo padrão
    E.2.2Secondary objectives of the trial
    To determine the maximum dose tolerated and the recommended phase 2 dose
    To compare the rate of CR/CRi with MRD negativity after one cycle on induction between arms
    To compare the DFS, OS, CIR, non-relapse mortality between arms
    To assess the rate of MRD negativity after consolidation 2, off-therapy, pre-allo-SCT
    To assess the rate of molecular relapse
    To assess the feasibility of a maintenance schedule in the SCT and non-SCT setting
    Subanalyses on efficacy and safety in different populations
    To assess the impact of potential baseline factors for a response
    To evaluate early mortality
    To evaluate the impact on the use of medical resources
    To evaluate the post-remission schedules according to a predefined risk-adapted strategy
    Biological procedures to gain insight on the mechanism of action of quizartinib in FLT3-ITD-WT AML
    To evaluate the clinical benefits, safety, tolerability, and health-related quality of life (HRQOL)
    Determinar a DMT e a dose recomendada da fase 2
    Comparar a taxa de RC/RCi com a DRM negativa após 1 ciclo de indução entre grupos
    Comparar a taxa de SLD, a SG, a ICR e a mortalidade sem recidiva entre grupos
    Avaliar a taxa de DRM negativa após a fase de consolidação 2, sem terapêutica, antes do Alo-SCT
    Avaliar a taxa de recidiva molecular
    Avaliar a exequibilidade do regime de manutenção no cenário com e sem SCT
    Subanálises da eficácia e segurança em diferentes populações
    Avaliar o impacto de potenciais fatores da linha basal na resposta
    Avaliar a mortalidade precoce
    Avaliar o impacto na utilização de recursos médicos
    Avaliar os regimes pós-remissão de acordo com uma estratégia pré-definida adaptada ao risco
    Realizar procedimentos biológicos para obter informações sobre o mecanismo de ação do Quizartinib na LMA sem mutação ITD do gene FLT3
    Avaliar os benefícios clínicos, a segurança, a tolerabilidade e a qualidade de vida relacionada com a saúde
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent before the first screening procedure. The patient and the investigator must sign informed consent form.
    2. Diagnosis of untreated AML (according to the WHO 2008/2016 definition)
    3. Age ≥ 18 and ≤70 years old at the time of screening
    4. Non-FLT3-ITD (allelic ratio <0.03) at diagnosis
    5. Considered eligible to receive intensive chemotherapy as per investigator judgment
    6. ECOG 0-2
    7. No contraindications for quizartinib
    8. The subject is receiving standard “7+3" induction chemotherapy regimen as specified in the protocol
    9. No severe organ function abnormalities
    10. Not included in other first-line trials
    11. Cardiac ejection fraction ≥ 45% assessed by echocardiography or MUGA.
    12. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception upon enrollment, during the treatment period and for 3 months following the last dose of investigational drug or cytarabine, whichever is later
    13. Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later
    14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    1. Consentimento informado por escrito de acordo com as diretrizes nacionais, locais e institucionais. O doente deve fornecer o consentimento informado antes do primeiro procedimento de seleção. O doente e o investigador devem assinar o formulário de consentimento informado.
    2. Diagnóstico de LMA não tratada (de acordo com a definição da OMS 2008/2016)
    3. Idade ≥ 18 e ≤70 anos no momento da seleção
    4. Gene FLT3 sem mutação ITD (relação alélica <0,03) no momento do diagnóstico
    5. Considerado elegível para receber quimioterapia intensiva segundo a opinião do investigador
    6. Estado funcional segundo o Eastern Cooperative Oncology Group (ECOG) de 0-2
    7. Sem contraindicações para o Quizartinib
    8. O doente estar a receber um regime padrão de quimioterapia de indução «7+3» conforme especificado no protocolo
    9. Sem anomalias funcionais orgânicas graves
    10. Não incluído noutros ensaios de primeira linha
    11. Fração de ejeção cardíaca ≥ 45% avaliada por eletrocardiograma ou MUGA
    12. Doentes do sexo feminino em idade fértil devem ter um teste de gravidez no sangue negativo no momento da seleção e aceitar utilizar métodos fiáveis de contraceção aquando da inclusão no estudo, durante o período de tratamento e durante 3 meses após a toma da última dose do medicamento experimental ou Citarabina, consoante o que for tomado mais tarde
    13. Doentes do sexo masculino devem utilizar um método fiável de contraceção (se forem sexualmente ativos com uma mulher em idade fértil) aquando da inclusão no estudo, durante o período de tratamento e durante 6 meses após a toma da última dose do medicamento experimental ou Citarabina, consoante o que for tomado mais tarde
    14. Disponibilidade e capacidade para cumprir as visitas programadas, os planos de tratamento, os testes laboratoriais e outros procedimentos do estudo.
    E.4Principal exclusion criteria
    1. Patients with a genetic diagnosis of acute promyelocytic leukemia
    2. Age <18 years or >70 years
    3. ECOG performance status of 3 or 4
    4. Prior treatment for AML, except for the following allowances:
    a) Leukapheresis
    b) Treatment for hyperleukocytosis with hydroxyurea
    5. Blastic phase of bcr/abl chronic myeloid leukemia.
    6. Presence of an associated active and/or uncontrolled malignancy: patients with another neoplastic disease, for whom the Investigator has a clinical suspicion of active disease at the time of enrollment. Note: Patients with adequately treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for this study. Hormonal or adjuvant therapies will be allowed for breast cancer or prostate cancer as long as they are on a stable dose for at least 2 weeks before the first dose.
    7. Known active and not controlled hepatitis B or hepatitis C infection. In the event of a positive viral load, please consult with the Sponsor
    8. Known human immunodeficiency virus (HIV) infection
    9. Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial
    10. Serum creatinine ≥ 250 μmol/l (≥ 2.5 mg/dL) (unless it is attributable to AML activity)
    11. Bilirubin, alkaline phosphatase, or SGOT > 3 times the normal upper limit (unless it is attributable to AML activity)
    12. Uncontrolled or significant cardiovascular disease, including any of the following:
    a. Symptomatic bradycardia of fewer than 50 beats per minute, unless the subject has a pacemaker;
    b. QTcF >450 msec at Screening. Note: QTcF will be derived from the mean of triplicate readings;
    c. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
    d. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg;
    e. History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
    f. History of a second (Mobitz II) or third-degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker)
    g. An ejection fraction <45%
    h. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening
    i. History of New York Heart Association Class 3 or 4 heart failure
    j. Right bundle branch and left anterior hemiblock (bifascicular block), complete left bundle branch block
    13. History of hypersensitivity to any excipients in the quizartinib/placebo tablets
    14. Females who are pregnant or breastfeeding
    15. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib.
    16. Active acute or chronic GVHD requiring prednisone >10 mg or equivalent corticosteroid daily.
    1. Doentes com diagnóstico genético de leucemia promielocítica aguda
    2. Idade <18 anos ou >70 anos
    3. Estado funcional segundo o Eastern Cooperative Oncology Group (ECOG) de 3 ou 4
    4. Tratamento prévio da LMA, com exceção dos seguintes tratamentos:
    a) Leucoférese
    b) Tratamento de hiperleucocitose com hidroxiureia
    5. Fase blástica da leucemia mieloide crónica bcr/abl
    6. Presença de uma malignidade associada ativa e/ou não controlada: doentes com outra doença neoplásica, relativamente aos quais o investigador tem uma suspeita clínica de doença ativa no momento da inclusão no estudo. Nota: Os doentes com carcinoma precoce de células escamosas da pele devidamente tratado, carcinoma de células basais da pele ou neoplasia intra-epitelial cervical são elegíveis para este estudo. Serão permitidas terapêuticas hormonais ou adjuvantes para o cancro da mama ou da próstata, desde que se encontrem numa dose estável durante, pelo menos, 2 semanas antes da primeira dose.
    7. Conhecimento de infeção ativa e não controlada por hepatite B ou hepatite C. Caso se verifique carga viral positiva, o investigador deve consultar o Promotor
    8. Conhecimento de infeção pelo vírus da imunodeficiência humana (VIH)
    9. Presença de qualquer doença psiquiátrica grave ou condição física que, de acordo com os critérios do médico, torne contraindicada a inclusão do doente no ensaio clínico
    10. Creatinina sérica ≥ 250 μmol/l (≥ 2,5 mg/dL) (exceto se for atribuível à atividade da LMA)
    11. Bilirrubina, fosfatase alcalina ou SGOT> 3 vezes o limite superior normal (exceto se for atribuível à atividade da LMA)
    12. Doença cardiovascular não controlada ou significativa, incluindo qualquer uma das seguintes situações:
    a. Bradicardia sintomática com menos de 50 batimentos por minuto, exceto se o participante tiver um pacemaker;
    b. QTcF> 450 msec na Seleção. Nota: O QTcF será obtido a partir da média das leituras do ECG em triplicado;
    c. Diagnóstico ou suspeita de síndrome de QT longo (incluindo historial familiar de síndrome de QT longo);
    d. Pressão arterial sistólica ≥180 mmHg ou pressão arterial diastólica ≥ 110 mmHg;
    e. Historial de arritmias ventriculares clinicamente relevantes (por exemplo, taquicardia ventricular, fibrilhação ventricular ou Torsade de Pointes)
    f. Historial de um bloqueio cardíaco de segundo (Mobitz II) ou terceiro grau (os participantes com pacemakers podem participar no estudo se não tiverem historial de desmaios ou arritmias clinicamente relevantes durante o uso do pacemaker)
    g. Fração de ejeção <45%
    h. Historial de angina de peito não controlado ou enfarte do miocárdio durante os 6 meses anteriores à Seleção
    i. Historial de insuficiência cardíaca de Classe 3 ou 4 segundo a New York Heart Association
    j. Presença de hemibloqueio anterior esquerdo e do ramo direito (bloqueio bifascicular), bloqueio completo do ramo esquerdo
    13. Historial de hipersensibilidade a qualquer excipiente nos comprimidos de Quizartinib/placebo
    14. Mulheres que estejam grávidas e/ou a amamentar
    15. Qualquer doente com diminuição significativa conhecida da função gastrointestinal ou doença gastrointestinal que possa alterar significativamente a absorção de Quizartinib.
    16. Doença de enxerto contra o hospedeiro (DECH) ativa aguda ou crónica que necessite de Prednisona> 10 mg ou de um corticosteroide equivalente diariamente.
    E.5 End points
    E.5.1Primary end point(s)
    Event-free survival (EFS): failure to achieve CR/CRi after 1 or 2 induction cycles, death in CR/CRi or relapse, whichever occurs the first
    Sobrevivência livre de eventos (SLE): falha na obtenção de remissão completa/remissão completa com recuperação hematológica incompleta (RC/RCi) após 1 ou 2 ciclos de indução, morte na RC/RCi ou recidiva, o que ocorrer primeiro
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    Ao longo do estudo
    E.5.2Secondary end point(s)
    - Maximum dose tolerated and recommended phase 2 dose
    - Rate of CR/CRi with MRD negativity
    - Adverse events
    - Disease Free Survival
    - Rate of MRD negativity
    - Rate of molecular relapse
    - Impact of potential baseline factors for a response
    - Early mortality
    - Use of medical resources during the treatment phase (antibiotics, transfusions, duration of hospitalization, need of central venous line)
    - Health-related quality of life
    - Dose máxima tolerada e dose recomendada da fase 2
    - Taxa de RC/RCi com doença residual mínima negativa
    - Acontecimentos adversos
    - Sobrevivência livre de doença
    - Taxa de doença residual mínima negativa
    - Taxa de recidiva molecular
    - Impacto de potenciais fatores da linha basal na resposta
    - Mortalidade precoce
    - Utilização de recursos médicos durante a fase de tratamento (antibióticos, transfusões, duração da hospitalização, necessidade de cateter venoso central)
    - Qualidade de vida relacionada com a saúde
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Maximum dose tolerated and recommended phase 2 dose: maximum of 59 days since day 1 of induction chemotherapy
    - Rate of CR/CRi with MRD negativity: throughout the study
    - Adverse events: throughout the study
    - Disease Free Survival: throughout the study
    - Rate of MRD negativity: throughout the study
    - Rate of molecular relapse: throughout the study
    - Impact of potential baseline factors for a response: throughout the study
    - Early mortality: first 60 days
    - Use of medical resources during the treatment phase (antibiotics, transfusions, duration of hospitalization, need of central venous line): throughout the study
    - Health-related quality of life: throughout the study
    - Dose máxima tolerada e dose recomendada da fase 2: máximo de 59 dias desde o dia 1 da quimioterapia de indução
    - Taxa de RC/RCi com doença residual mínima negativa: ao longo do estudo
    - Acontecimentos adversos: ao longo do estudo
    - Sobrevivência livre de doença: ao longo do estudo
    - Taxa de doença residual mínima negativa: ao longo do estudo
    - Taxa de recidiva molecular: ao longo do estudo
    - Impacto de potenciais fatores da linha basal na resposta: ao longo do estudo
    - Mortalidade precoce: primeiros 60 dias
    - Utilização de recursos médicos durante a fase de tratamento (antibióticos, transfusões, duração da hospitalização, necessidade de cateter venoso central): ao longo do estudo
    - Qualidade de vida relacionada com a saúde: ao longo do estudo
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised 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 Yes
    E.8.1.7.1Other trial design description
    Fase de segurança aberta para seleccionar dose da Fase II-controlada, aleatorizada, duplamente cega
    Safety phase (open label) to select phase II dose. Phase II is controlled, randomised, double blind
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Last patient last visit
    Última visita do último doente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 181
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 91
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 231
    F.4.2.2In the whole clinical trial 272
    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. According to standard of care
    Nenhum. De acordo com a prática clínica usual
    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 Decision2020-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 06:44:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA