[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100371147":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":36,"locations":58,"responsibleParty":211,"collaborators":213,"id":219,"slug":220,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":36,"eligibilityCriteria":225,"healthyVolunteers":221,"sex":226,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":36,"studyType":232,"phases":233,"briefSummary":236,"conditions":237,"keywords":36,"overallStatus":239,"whyStopped":36,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"PETHEMA Foundation","OTHER",[8,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Level dose 1 - 40mg, 14 days","EXPERIMENTAL","Patients will receive an induction cycle (40mg Quizartinib for 14 days) followed by 1-3 consolidation cycles (Quizartinib at day 6) \\[with or without allogenic stem cell transplantation\\]- Responders will have 12 months maintenance starting at 30mg\u002Fday Quizartinib will be increased to 60 mg\u002Fday after 15 days if appropriate.",[13,14,15,16,17],"Drug: Quizartinib","Drug: Fludarabine","Drug: Cytarabine","Drug: Idarubicin","Drug: glycosylated G-CSF",{"label":19,"type":10,"description":20,"interventionNames":21},"Level dose 2 - 60mg, 14 days","Patients will receive an induction cycle (60mg Quizartinib for 14 days) followed by 1-3 consolidation cycles (Quizartinib at day 6) \\[with or without allogenic stem cell transplantation\\]- Responders will have 12 months maintenance starting at 30mg\u002Fday Quizartinib will be increased to 60 mg\u002Fday after 15 days if appropriate.",[13,14,15,16,17],{"label":23,"type":10,"description":24,"interventionNames":25},"Level dose -1 - 60mg 7days","Patients will receive an induction cycle (60mg Quizartinib for 7 days) followed by 1-3 consolidation cycles (Quizartinib at day 6) \\[with or without allogenic stem cell transplantation\\]- Responders will have 12 months maintenance starting at 30mg\u002Fday Quizartinib will be increased to 60 mg\u002Fday after 15 days if appropriate.",[13,14,15,16,17],{"label":27,"type":10,"description":28,"interventionNames":29},"Level dose -2 - 40mg 7 days","Patients will receive an induction cycle (40mg Quizartinib for 7days) followed by 1-3 consolidation cycles (Quizartinib at day 6) \\[with or without allogenic stem cell transplantation\\]- Responders will have 12 months maintenance starting at 30mg\u002Fday Quizartinib will be increased to 60 mg\u002Fday after 15 days if appropriate.",[13,14,15,16,17],[31,37,41,45,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Quizartinib","Quizartinib at different doses in the phase I (40mg-14 days; 60mg-14 days; 60mg-7days, 40mg-7days). RP2D in the phase II part.",[23,27,9,19],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Fludarabine","30 mg\u002Fm2 intravenous days 1 to 4 of the cycle",[23,27,9,19],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Cytarabine","2 g\u002Fm 2 intravenous days 1 to 4 (1 g\u002Fm2 in patients older than 59) of the cycle",[23,27,9,19],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Idarubicin","10 mg\u002F 2 intravenous days 1 to 3 of the cycle",[23,27,9,19],{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":36},"glycosylated G-CSF","daily dose of 300 mcg\u002Fm 2 , from day -1 until day 5 of the cycle",[23,27,9,19],[54],{"name":55,"affiliation":56,"role":57},"Pau Montesinos, MD","Trial Coordinator, Institution Contact","STUDY_DIRECTOR",[59,70,78,86,89,97,105,113,121,129,137,142,150,155,163,171,179,187,195,203],{"facility":60,"status":36,"city":61,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":36},"Complexo Hospitalario Universitario A Coruña","A Coruña","Spain","ES",{"type":65,"coordinates":66},"Point",[67,68],-8.396,43.37135,{"lat":68,"lon":67},{"facility":71,"status":36,"city":72,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":73,"geoPoint":77,"contacts":36},"Hospital General Universitario de Alicante","Alicante",{"type":65,"coordinates":74},[75,76],-0.48149,38.34517,{"lat":76,"lon":75},{"facility":79,"status":36,"city":80,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":81,"geoPoint":85,"contacts":36},"Institut Català D'Oncologia-Hospital Germans Trias I Pujol","Badalona",{"type":65,"coordinates":82},[83,84],2.24741,41.45004,{"lat":84,"lon":83},{"facility":87,"status":36,"city":88,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":36,"geoPoint":36,"contacts":36},"Institut Català D'Oncologia-Hospital Duran I Reynals","Bellvitge",{"facility":90,"status":36,"city":91,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":92,"geoPoint":96,"contacts":36},"Hospital Universitario Puerta Del Mar","Cadiz",{"type":65,"coordinates":93},[94,95],-6.2891,36.52672,{"lat":95,"lon":94},{"facility":98,"status":36,"city":99,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":100,"geoPoint":104,"contacts":36},"Hospital San Pedro de Alcántara","Cáceres",{"type":65,"coordinates":101},[102,103],-6.37224,39.47649,{"lat":103,"lon":102},{"facility":106,"status":36,"city":107,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":108,"geoPoint":112,"contacts":36},"Hospital Universitario Reina Sofía","Córdoba",{"type":65,"coordinates":109},[110,111],-4.77275,37.89155,{"lat":111,"lon":110},{"facility":114,"status":36,"city":115,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":116,"geoPoint":120,"contacts":36},"ICO Girona - Hospital Josep Trueta","Girona",{"type":65,"coordinates":117},[118,119],2.82493,41.98311,{"lat":119,"lon":118},{"facility":122,"status":36,"city":123,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":124,"geoPoint":128,"contacts":36},"Hospital Universitario de Jerez de La Frontera","Jerez de la Frontera",{"type":65,"coordinates":125},[126,127],-6.13606,36.68645,{"lat":127,"lon":126},{"facility":130,"status":36,"city":131,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":132,"geoPoint":136,"contacts":36},"Complejo Hospitalario de Gran Canaria Dr. Negrin","Las Palmas de Gran Canaria",{"type":65,"coordinates":133},[134,135],-15.41573,28.10178,{"lat":135,"lon":134},{"facility":138,"status":36,"city":131,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":139,"geoPoint":141,"contacts":36},"Complejo Hospitalario Universitario Insular-Materno Infantil",{"type":65,"coordinates":140},[134,135],{"lat":135,"lon":134},{"facility":143,"status":36,"city":144,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":145,"geoPoint":149,"contacts":36},"Hospital Ramón Y Cajal","Madrid",{"type":65,"coordinates":146},[147,148],-3.70256,40.4165,{"lat":148,"lon":147},{"facility":151,"status":36,"city":144,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":152,"geoPoint":154,"contacts":36},"Hospital Universitario 12 de Octubre",{"type":65,"coordinates":153},[147,148],{"lat":148,"lon":147},{"facility":156,"status":36,"city":157,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":158,"geoPoint":162,"contacts":36},"Hospital Universitario Virgen de La Victoria","Málaga",{"type":65,"coordinates":159},[160,161],-4.42034,36.72016,{"lat":161,"lon":160},{"facility":164,"status":36,"city":165,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":166,"geoPoint":170,"contacts":36},"Hospital Universitario Central de Asturias","Oviedo",{"type":65,"coordinates":167},[168,169],-5.84476,43.36029,{"lat":169,"lon":168},{"facility":172,"status":36,"city":173,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":174,"geoPoint":178,"contacts":36},"Hospital Universitari Son Espases","Palma de Mallorca",{"type":65,"coordinates":175},[176,177],2.65024,39.56939,{"lat":177,"lon":176},{"facility":180,"status":36,"city":181,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":182,"geoPoint":186,"contacts":36},"Clínica Universitaria de Navarra","Pamplona",{"type":65,"coordinates":183},[184,185],-1.64323,42.81687,{"lat":185,"lon":184},{"facility":188,"status":36,"city":189,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":190,"geoPoint":194,"contacts":36},"Hospital Universitario Virgen Del Rocío","Seville",{"type":65,"coordinates":191},[192,193],-5.97317,37.38283,{"lat":193,"lon":192},{"facility":196,"status":36,"city":197,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":198,"geoPoint":202,"contacts":36},"Hospital Universitari Joan Xxiii de Tarragona","Tarragona",{"type":65,"coordinates":199},[200,201],1.24544,41.11905,{"lat":201,"lon":200},{"facility":204,"status":36,"city":205,"state":36,"zip":36,"country":62,"countryCode":63,"cosmosGeoPoint":206,"geoPoint":210,"contacts":36},"Hospital Universitari i Politècnic La Fe","Valencia",{"type":65,"coordinates":207},[208,209],-0.37966,39.47391,{"lat":209,"lon":208},{"type":212,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[214,217],{"name":215,"class":216},"Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company","INDUSTRY",{"name":218,"class":216},"Syntax for Science, S.L","100371147","phase-1-a-clinical-trial-to-assess-the-efficacy-and-safety-of-the-combination-of-a-drug-call-quizartinib-with-chemotherapy-flag-ida-in-patients-with-acute-myeloid-leukemia-that-has-not-responded-to-the-first-treatment-or-that-has-returned-after-the-first-treatment-100371147",false,"NCT04112589","A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment","A Multicenter, Prospective, Non-randomized, Phase I-II Trial to Assess the Efficacy and Safety of the Combination of Oral Quizartinib and the FLAG-IDA Chemotherapy Regimen in First Relapsed\u002FRefractory Acute Myeloid Leukemia (R\u002FR AML) Patients","Inclusion Criteria:\n\n1. Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. Informed consent form must be signed by the patient and the Investigator.\n2. Patients aged ≥ 18 years old and ≤70 years old at the time of screening.\n3. First R\u002FR AML defined as:\n\n   * First relapse after frontline intensive chemotherapy (with or without prior alloSCT), irrespectively of the duration of the first CR. Patients previously treated with a FLT3 inhibitor different from quizartinib, can be included.\n   * First refractory disease (defined as patients not achieving at least a PR after first induction cycle and\u002For not achieving CR\u002FCRi after first 2 cycles). Patients previously treated with a FLT3 inhibitor different from quizartinib, can be included.\n4. Non-APL AML.\n5. Considered for intensive approach as per Investigator judgment.\n6. ECOG 0-2.\n7. No contraindications for quizartinib.\n8. No contraindications for intensive chemotherapy.\n9. No severe organ function abnormalities.\n10. No active relevant GVHD.\n11. For the Phase II, FLT3-ITD patients will represent 50% of the study cohort (FLT3-TKD are not excluded but included in the FLT3-ITD-WT group).\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 6 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 6 months following the last dose of investigational drug or cytarabine, whichever is later.\n\nExclusion Criteria:\n\n1. Patients with genetic diagnosis of acute promyelocytic leukemia.\n2. Blastic phase of bcr\u002Fabl chronic myeloid leukemia.\n3. Patients with other neoplastic disease, for whom the Investigator has 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 if they are on a stable dose for at least 2 weeks prior to first dose.\n4. Presence of any severe psychiatric disease or physical condition\u002Fcomorbidity that, according to the physician´s criteria, contraindicates the inclusion of the patient in the clinical trial\n5. Serum creatinine ≥ 250 μmol\u002Fl (≥ 2.5 mg\u002FdL) (unless it is attributable to AML activity).\n6. Bilirubin, alkaline phosphatase, or SGOT \\>3 times the upper normal limit (unless it is attributable to AML activity).\n7. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * Symptomatic bradycardia of less than 50 beats per minute, unless the subject has a pacemaker.\n   * QTcF \\>450 ms at screening. Note: QTcF will be derived from the mean of triplicate readings.\n   * Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome)\n   * History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes).\n   * History of 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   * History of uncontrolled angina pectoris or myocardial infarction within 6months prior to Screening.\n   * History of New York Heart Association Class 3 or 4 heart failure.\n   * Complete left bundle branch block.\n   * Right bundle branch and left anterior hemiblock (bifascicular block)\n   * Infarction (MI) within 3 months.\n   * Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg\n   * A previously known left ventricle ejection fraction \\\u003C45%\n8. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.\n9. Active hepatitis B or hepatitis C infection.\n10. Previously known and documented human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study).\n11. Active acute or chronic GVHD requiring prednisone \\>10 mg or equivalent corticosteroid daily\n12. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib\n13. History of hypersensitivity to any excipients in the quizartinib tablets.\n14. Females who are pregnant or breastfeeding.\n15. Isolated extramedullary R\u002FR AML.\n16. Only applicable to patients screened after the first cohort of 34 patients of the Phase II has been achieved (e.g., FLT3-ITD negative): patients must have a confirmation of FLT3-ITD status at relapse, and this must correspond to the non-achieved cohort (e.g. FLT3-ITD positive).","ALL","18 Years","70 Years",{"count":230,"type":231},63,"ACTUAL","INTERVENTIONAL",[234,235],"PHASE1","PHASE2","This is a multicenter, prospective, non-randomized, Phase I-II trial to assess the efficacy and safety of the combination of oral quizartinib and FLAG-IDA chemotherapy schedule (FLAG-QUIDA regimen) in first relapsed\u002Frefractory AML (acute myeloid leukemia) patients.",[238],"Acute Myeloid Leukemia","UNKNOWN","2022-03-11",{"date":242,"type":231},"2022-03-14",{"date":244,"type":231},"2019-12-26",{"date":246,"type":247},"2023-12","ESTIMATED",{"name":5,"class":6},20]