[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370774":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":27,"locations":45,"responsibleParty":423,"collaborators":425,"id":431,"slug":432,"hasResults":433,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":27,"eligibilityCriteria":437,"healthyVolunteers":433,"sex":438,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":27,"studyType":444,"phases":445,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":451,"whyStopped":27,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},{"fullName":5,"class":6},"PETHEMA Foundation","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Quizartinib","EXPERIMENTAL","Induction: Cytarabine continuous IV infusion 200 mg\u002Fm2 (days 1-7), Idarubicin IV infusion 12 mg\u002Fm2 (days 1-3), oral quizartinib (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.\n\nConsolidation: Cytarabine IV infusion 1,5-3 g\u002Fm2 (days 1, 3, 5), oral quizartinib (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.\n\nMaintenance: oral quizartinib 60mg\u002Fday (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days",[13,14,15],"Drug: Quizartinib","Drug: Cytarabine","Drug: Idarubicin",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR","Induction: Cytarabine continuous IV infusion 200 mg\u002Fm2 (days 1-7), Idarubicin IV infusion 12 mg\u002Fm2 (days 1-3), oral placebo (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.\n\nConsolidation: Cytarabine IV infusion 1,5-3 g\u002Fm2 (days 1, 3, 5), oral placebo (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.\n\nMaintenance: oral placebo 60mg\u002Fday (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days.",[21,14,15],"Drug: Placebo oral tablet",[23,28,32,36],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Induction: oral quizartinib (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.\n\nConsolidation: oral quizartinib (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.\n\nMaintenance: oral quizartinib 60mg\u002Fday (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days.",[9],null,{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Placebo oral tablet","Induction: oral placebo (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.\n\nConsolidation: oral placebo (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.\n\nMaintenance: oral placebo 60mg\u002Fday (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days.",[17],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Cytarabine","Induction: Cytarabine continuous IV infusion, 200 mg\u002Fm2 (days 1-7), up to 2 cycles of 35 days.\n\nConsolidation: Cytarabine IV infusion, 1,5-3 g\u002Fm2 (days 1, 3, 5), up to 4 cycles of 35 days.",[17,9],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Idarubicin","Induction: Idarubicin IV infusion 12 mg\u002Fm2 (days 1-3), up to 2 cycles of 35 days.",[17,9],[41],{"name":42,"affiliation":43,"role":44},"Pau Montesinos","Hospital Universitari i Politecnic La Fe","PRINCIPAL_INVESTIGATOR",[46,59,64,74,84,94,104,114,124,134,144,153,162,171,179,188,196,205,214,223,232,241,250,258,264,269,274,279,288,293,300,309,318,326,335,344,353,361,370,379,385,390,399,408,413],{"facility":47,"status":27,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":27},"Complejo Hospitalario Universitario de A Coruña","Santiago de Compostela","A Coruña","15706","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],-8.54569,42.88052,{"lat":57,"lon":56},{"facility":60,"status":27,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":61,"geoPoint":63,"contacts":27},"Complejo Hospitalario Universitario de Santiago",{"type":54,"coordinates":62},[56,57],{"lat":57,"lon":56},{"facility":65,"status":27,"city":66,"state":67,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":27},"Hospital Universitari Germans Trias i Pujol","Badalona","Barcelona","08916",{"type":54,"coordinates":70},[71,72],2.24741,41.45004,{"lat":72,"lon":71},{"facility":75,"status":27,"city":76,"state":77,"zip":78,"country":51,"countryCode":52,"cosmosGeoPoint":79,"geoPoint":83,"contacts":27},"Hospital General Univesitario de Castellón","Castellon","Castellón","12004",{"type":54,"coordinates":80},[81,82],-0.04935,39.98567,{"lat":82,"lon":81},{"facility":85,"status":27,"city":86,"state":87,"zip":88,"country":51,"countryCode":52,"cosmosGeoPoint":89,"geoPoint":93,"contacts":27},"Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín","Las Palmas de Gran Canaria","Las Palmas","35020",{"type":54,"coordinates":90},[91,92],-15.41573,28.10178,{"lat":92,"lon":91},{"facility":95,"status":27,"city":96,"state":97,"zip":98,"country":51,"countryCode":52,"cosmosGeoPoint":99,"geoPoint":103,"contacts":27},"Hospital Universitario Quirón Salud Madrid","Pozuelo de Alarcón","Madrid","28223",{"type":54,"coordinates":100},[101,102],-3.81338,40.43293,{"lat":102,"lon":101},{"facility":105,"status":27,"city":106,"state":107,"zip":108,"country":51,"countryCode":52,"cosmosGeoPoint":109,"geoPoint":113,"contacts":27},"Hospital General Universitario Santa Lucía","Cartagena","Murcia","30200",{"type":54,"coordinates":110},[111,112],-0.98397,37.60197,{"lat":112,"lon":111},{"facility":115,"status":27,"city":116,"state":117,"zip":118,"country":51,"countryCode":52,"cosmosGeoPoint":119,"geoPoint":123,"contacts":27},"Complejo Hospitalario Universitario de Vigo","Vigo","Pontevedra","36312",{"type":54,"coordinates":120},[121,122],-8.72264,42.23282,{"lat":122,"lon":121},{"facility":125,"status":27,"city":126,"state":127,"zip":128,"country":51,"countryCode":52,"cosmosGeoPoint":129,"geoPoint":133,"contacts":27},"Hospital Universitario de Canarias","San Cristóbal de La Laguna","Santa Cruz De Tenerife","38320",{"type":54,"coordinates":130},[131,132],-16.32014,28.4853,{"lat":132,"lon":131},{"facility":135,"status":27,"city":136,"state":137,"zip":138,"country":51,"countryCode":52,"cosmosGeoPoint":139,"geoPoint":143,"contacts":27},"Hospital Universitario de Basurto","Bilbao","Vizcaya","48013",{"type":54,"coordinates":140},[141,142],-2.92528,43.26271,{"lat":142,"lon":141},{"facility":145,"status":27,"city":146,"state":137,"zip":147,"country":51,"countryCode":52,"cosmosGeoPoint":148,"geoPoint":152,"contacts":27},"Hospital Universitario de Galdakao","Galdakao","48960",{"type":54,"coordinates":149},[150,151],-2.8429,43.23073,{"lat":151,"lon":150},{"facility":154,"status":27,"city":155,"state":27,"zip":156,"country":51,"countryCode":52,"cosmosGeoPoint":157,"geoPoint":161,"contacts":27},"Complejo Hospitalario de Albacete","Albacete","02006",{"type":54,"coordinates":158},[159,160],-1.85643,38.99424,{"lat":160,"lon":159},{"facility":163,"status":27,"city":164,"state":27,"zip":165,"country":51,"countryCode":52,"cosmosGeoPoint":166,"geoPoint":170,"contacts":27},"Hospital General Universitario de Alicante","Alicante","03010",{"type":54,"coordinates":167},[168,169],-0.48149,38.34517,{"lat":169,"lon":168},{"facility":172,"status":27,"city":67,"state":27,"zip":173,"country":51,"countryCode":52,"cosmosGeoPoint":174,"geoPoint":178,"contacts":27},"Hospital Universitari Vall Hebron","08035",{"type":54,"coordinates":175},[176,177],2.15899,41.38879,{"lat":177,"lon":176},{"facility":180,"status":27,"city":181,"state":27,"zip":182,"country":51,"countryCode":52,"cosmosGeoPoint":183,"geoPoint":187,"contacts":27},"Hospital Universitario de Burgos","Burgos","09006",{"type":54,"coordinates":184},[185,186],-3.70184,42.34106,{"lat":186,"lon":185},{"facility":189,"status":27,"city":190,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":191,"geoPoint":195,"contacts":27},"Hospital Puerta del Mar","Cadiz",{"type":54,"coordinates":192},[193,194],-6.2891,36.52672,{"lat":194,"lon":193},{"facility":197,"status":27,"city":198,"state":27,"zip":199,"country":51,"countryCode":52,"cosmosGeoPoint":200,"geoPoint":204,"contacts":27},"Hospital San Pedro de Alcántara","Cáceres","10003",{"type":54,"coordinates":201},[202,203],-6.37224,39.47649,{"lat":203,"lon":202},{"facility":206,"status":27,"city":207,"state":27,"zip":208,"country":51,"countryCode":52,"cosmosGeoPoint":209,"geoPoint":213,"contacts":27},"Complejo Hospitalario Regional Reina Sofía","Córdoba","14004",{"type":54,"coordinates":210},[211,212],-4.77275,37.89155,{"lat":212,"lon":211},{"facility":215,"status":27,"city":216,"state":27,"zip":217,"country":51,"countryCode":52,"cosmosGeoPoint":218,"geoPoint":222,"contacts":27},"Hospital Universitario Virgen de las Nieves","Granada","18014",{"type":54,"coordinates":219},[220,221],-3.60667,37.18817,{"lat":221,"lon":220},{"facility":224,"status":27,"city":225,"state":27,"zip":226,"country":51,"countryCode":52,"cosmosGeoPoint":227,"geoPoint":231,"contacts":27},"Hospital Juan Ramón Jiménez","Huelva","21005",{"type":54,"coordinates":228},[229,230],-6.94004,37.26638,{"lat":230,"lon":229},{"facility":233,"status":27,"city":234,"state":27,"zip":235,"country":51,"countryCode":52,"cosmosGeoPoint":236,"geoPoint":240,"contacts":27},"Complejo Hospitalario de Jaén","Jaén","23007",{"type":54,"coordinates":237},[238,239],-3.79028,37.76922,{"lat":239,"lon":238},{"facility":242,"status":27,"city":243,"state":27,"zip":244,"country":51,"countryCode":52,"cosmosGeoPoint":245,"geoPoint":249,"contacts":27},"Complejo Hospitalario Lucus Augusti","Lugo","27003",{"type":54,"coordinates":246},[247,248],-7.55602,43.00992,{"lat":248,"lon":247},{"facility":251,"status":27,"city":97,"state":27,"zip":252,"country":51,"countryCode":52,"cosmosGeoPoint":253,"geoPoint":257,"contacts":27},"Fundación Jiménez Díaz","28040",{"type":54,"coordinates":254},[255,256],-3.70256,40.4165,{"lat":256,"lon":255},{"facility":259,"status":27,"city":97,"state":27,"zip":260,"country":51,"countryCode":52,"cosmosGeoPoint":261,"geoPoint":263,"contacts":27},"Hospital Universitario 12 de Octubre","28041",{"type":54,"coordinates":262},[255,256],{"lat":256,"lon":255},{"facility":265,"status":27,"city":97,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":266,"geoPoint":268,"contacts":27},"Hospital Clínico San Carlos",{"type":54,"coordinates":267},[255,256],{"lat":256,"lon":255},{"facility":270,"status":27,"city":97,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":271,"geoPoint":273,"contacts":27},"Hospital La Paz",{"type":54,"coordinates":272},[255,256],{"lat":256,"lon":255},{"facility":275,"status":27,"city":97,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":276,"geoPoint":278,"contacts":27},"Hospital Ramón y Cajal",{"type":54,"coordinates":277},[255,256],{"lat":256,"lon":255},{"facility":280,"status":27,"city":281,"state":27,"zip":282,"country":51,"countryCode":52,"cosmosGeoPoint":283,"geoPoint":287,"contacts":27},"Hospital Regional Universitario Málaga","Málaga","29010",{"type":54,"coordinates":284},[285,286],-4.42034,36.72016,{"lat":286,"lon":285},{"facility":289,"status":27,"city":281,"state":27,"zip":282,"country":51,"countryCode":52,"cosmosGeoPoint":290,"geoPoint":292,"contacts":27},"Hospital Universitario Virgen de la Victoria",{"type":54,"coordinates":291},[285,286],{"lat":286,"lon":285},{"facility":294,"status":27,"city":107,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":295,"geoPoint":299,"contacts":27},"Hospital Virgen de la Arrixaca",{"type":54,"coordinates":296},[297,298],-1.13004,37.98704,{"lat":298,"lon":297},{"facility":301,"status":27,"city":302,"state":27,"zip":303,"country":51,"countryCode":52,"cosmosGeoPoint":304,"geoPoint":308,"contacts":27},"Hospital Universitario Central de Asturias","Oviedo","33006",{"type":54,"coordinates":305},[306,307],-5.84476,43.36029,{"lat":307,"lon":306},{"facility":310,"status":27,"city":311,"state":27,"zip":312,"country":51,"countryCode":52,"cosmosGeoPoint":313,"geoPoint":317,"contacts":27},"Complejo Universitario de Navarra","Pamplona","31008",{"type":54,"coordinates":314},[315,316],-1.64323,42.81687,{"lat":316,"lon":315},{"facility":319,"status":27,"city":117,"state":27,"zip":320,"country":51,"countryCode":52,"cosmosGeoPoint":321,"geoPoint":325,"contacts":27},"Complejo Hospitalario de Pontevedra","36071",{"type":54,"coordinates":322},[323,324],-8.64435,42.431,{"lat":324,"lon":323},{"facility":327,"status":27,"city":328,"state":27,"zip":329,"country":51,"countryCode":52,"cosmosGeoPoint":330,"geoPoint":334,"contacts":27},"Hospital Universitario de Salamanca","Salamanca","37007",{"type":54,"coordinates":331},[332,333],-5.66388,40.96882,{"lat":333,"lon":332},{"facility":336,"status":27,"city":337,"state":27,"zip":338,"country":51,"countryCode":52,"cosmosGeoPoint":339,"geoPoint":343,"contacts":27},"Hospital Universitario Marques de Valdecilla","Santander","39008",{"type":54,"coordinates":340},[341,342],-3.80493,43.46589,{"lat":342,"lon":341},{"facility":345,"status":27,"city":346,"state":27,"zip":347,"country":51,"countryCode":52,"cosmosGeoPoint":348,"geoPoint":352,"contacts":27},"Complejo Hospitalario Regional Virgen del Rocío","Seville","41013",{"type":54,"coordinates":349},[350,351],-5.97317,37.38283,{"lat":351,"lon":350},{"facility":354,"status":27,"city":355,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":356,"geoPoint":360,"contacts":27},"Hospital Nuestra Señora del Prado","Talavera de la Reina",{"type":54,"coordinates":357},[358,359],-4.83076,39.96348,{"lat":359,"lon":358},{"facility":362,"status":27,"city":363,"state":27,"zip":364,"country":51,"countryCode":52,"cosmosGeoPoint":365,"geoPoint":369,"contacts":27},"Complejo Hospitalario de Toledo","Toledo","45004",{"type":54,"coordinates":366},[367,368],-4.02263,39.8581,{"lat":368,"lon":367},{"facility":371,"status":27,"city":372,"state":27,"zip":373,"country":51,"countryCode":52,"cosmosGeoPoint":374,"geoPoint":378,"contacts":27},"Hospital Clínico Universitario Valencia","Valencia","46010",{"type":54,"coordinates":375},[376,377],-0.37966,39.47391,{"lat":377,"lon":376},{"facility":380,"status":27,"city":372,"state":27,"zip":381,"country":51,"countryCode":52,"cosmosGeoPoint":382,"geoPoint":384,"contacts":27},"Hospital Universitario Dr. Peset Aleixandre","46017",{"type":54,"coordinates":383},[376,377],{"lat":377,"lon":376},{"facility":43,"status":27,"city":372,"state":27,"zip":386,"country":51,"countryCode":52,"cosmosGeoPoint":387,"geoPoint":389,"contacts":27},"46026",{"type":54,"coordinates":388},[376,377],{"lat":377,"lon":376},{"facility":391,"status":27,"city":392,"state":27,"zip":393,"country":51,"countryCode":52,"cosmosGeoPoint":394,"geoPoint":398,"contacts":27},"Hospital Clínico Universitario de Valladolid","Valladolid","47003",{"type":54,"coordinates":395},[396,397],-4.72353,41.65541,{"lat":397,"lon":396},{"facility":400,"status":27,"city":401,"state":27,"zip":402,"country":51,"countryCode":52,"cosmosGeoPoint":403,"geoPoint":407,"contacts":27},"Hospital Clínico Universitario Lozano Blesa","Zaragoza","50009",{"type":54,"coordinates":404},[405,406],-0.87734,41.65606,{"lat":406,"lon":405},{"facility":409,"status":27,"city":401,"state":27,"zip":402,"country":51,"countryCode":52,"cosmosGeoPoint":410,"geoPoint":412,"contacts":27},"Hospital Universitario Miguel Servet",{"type":54,"coordinates":411},[405,406],{"lat":406,"lon":405},{"facility":414,"status":27,"city":415,"state":416,"zip":417,"country":51,"countryCode":52,"cosmosGeoPoint":418,"geoPoint":422,"contacts":27},"Hospital Txagorritxu","Vitoria-Gasteiz","Álava","01009",{"type":54,"coordinates":419},[420,421],-2.67268,42.84998,{"lat":421,"lon":420},{"type":424,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[426,429],{"name":427,"class":428},"Dynamic Science S.L.","INDUSTRY",{"name":430,"class":428},"Daiichi Sankyo","100370774","phase-2-trial-to-compare-efficacy-and-safety-of-chemotherapyquizartinib-vs-chemotherapyplacebo-in-adults-fms-like-tyrosine-kinase-3-flt3-wild-type-acute-myeloid-leukemia-aml-100370774",false,"NCT04107727","Trial to Compare Efficacy and Safety of Chemotherapy\u002FQuizartinib vs Chemotherapy\u002FPlacebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)","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","Inclusion Criteria:\n\n1. 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.\n2. Diagnosis of untreated AML (according to the World Health Organization (WHO) 2008\u002F2016 definition)\n3. Age ≥ 18 and ≤70 years old at the time of screening\n4. Non-FLT3-ITD (allelic ratio \\\u003C0.03) at diagnosis\n5. Considered eligible to receive intensive chemotherapy as per investigator judgment\n6. Eastern Cooperative Oncology Group (ECOG) 0-2\n7. No contraindications for quizartinib\n8. The subject is receiving standard \"7+3\" induction chemotherapy regimen as specified in the protocol\n9. No severe organ function abnormalities\n10. Not included in other first-line trials\n11. Cardiac ejection fraction ≥ 45% assessed by echocardiography or multiple-gated acquisition (MUGA).\n12. 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\n13. 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 3 months following the last dose of investigational drug or cytarabine, whichever is later\n14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with a genetic diagnosis of acute promyelocytic leukemia\n2. Age \\\u003C18 years or \\>70 years\n3. ECOG performance status of 3 or 4\n4. Prior treatment for AML, except for the following allowances:\n\n   c) Leukapheresis d) Treatment for hyperleukocytosis with hydroxyurea\n5. Blastic phase of bcr\u002Fabl chronic myeloid leukemia.\n6. Presence of an associated active and\u002For uncontrolled malignancy:\n\n   \\- 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.\n7. Known active and not controlled hepatitis B or hepatitis C infection. In the event of a positive viral load, please consult with the Sponsor\n8. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study)\n9. 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\n10. Serum creatinine ≥ 250 μmol\u002Fl (≥ 2.5 mg\u002FdL) (unless it is attributable to AML activity)\n11. Bilirubin, alkaline phosphatase, or Serum glutamic oxaloacetic transaminase (SGOT) \\> 3 times the normal upper limit (unless it is attributable to AML activity)\n12. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n    1. Symptomatic bradycardia of fewer than 50 beats per minute, unless the subject has a pacemaker;\n    2. QT Comparison of Fridericia's (QTcF) \\>450 msec at Screening. Note: QTcF will be derived from the mean of triplicate readings;\n    3. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n    4. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg;\n    5. History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)\n    6. 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)\n    7. An ejection fraction \\\u003C45%\n    8. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening\n    9. History of New York Heart Association Class 3 or 4 heart failure\n    10. Right bundle branch and left anterior hemiblock (bifascicular block), complete left bundle branch block\n13. History of hypersensitivity to any excipients in the quizartinib\u002Fplacebo tablets\n14. Females who are pregnant or breastfeeding\n15. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib.\n16. Active acute or chronic Graft-Versus-Host-Disease (GVHD) requiring prednisone \\>10 mg or equivalent corticosteroid daily.","ALL","18 Years","70 Years",{"count":442,"type":443},273,"ACTUAL","INTERVENTIONAL",[446],"PHASE2","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 Acute Myeloid Leukemia",[449],"Acute Myeloid Leukemia",[9],"COMPLETED","2026-03-20",{"date":454,"type":443},"2026-03-24",{"date":456,"type":443},"2019-09-05",{"date":458,"type":443},"2025-01-24",{"name":5,"class":6},45]