[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495882":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":35,"locations":41,"responsibleParty":82,"collaborators":22,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":22,"enrollmentInfo":96,"targetDuration":22,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":75,"whyStopped":22,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Shanghai Tong Ren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment regimen based on C1D14 MRD","EXPERIMENTAL","Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy will be given azacitidine 75mg\u002Fm2, d1-7 and venetoclax 100mg on day 1 and 200mg on day 2, 400mg on day 3-28. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. Patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.",[13,14,15],"Drug: Azacitidine","Drug: Venetoclax","Drug: Selinexor",[17,23,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Azacitidine","75mg\u002Fm2 d1-7",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Venetoclax","d1 100mg, d2 200mg, d3-28 400mg",[9],[28],"ABT-199",{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Selinexor","if MRD positive in C1D14, selinexor 60mg D15, D22",[9],[34],"XPO1 inhibitor",[36],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},"Ligen Liu, MD","CONTACT","18017337037","liuligen@shsmu.edu.cn",[42,57,65,73],{"facility":43,"status":44,"city":45,"state":22,"zip":22,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Beizhan Hospital","NOT_YET_RECRUITING","Shanghai","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":22,"phoneExt":22,"email":22},"Jie Hao",{"facility":58,"status":44,"city":45,"state":22,"zip":22,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Pla Navy Feature Medical Center",{"type":49,"coordinates":60},[51,52],{"lat":52,"lon":51},[63],{"name":64,"role":38,"phone":22,"phoneExt":22,"email":22},"Rong Li",{"facility":66,"status":44,"city":45,"state":22,"zip":22,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Shanghai Ruijin Hospital",{"type":49,"coordinates":68},[51,52],{"lat":52,"lon":51},[71],{"name":72,"role":38,"phone":22,"phoneExt":22,"email":22},"Junmin Li",{"facility":74,"status":75,"city":45,"state":22,"zip":22,"country":46,"countryCode":47,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Shanghai Tong Ren hospital","RECRUITING",{"type":49,"coordinates":77},[51,52],{"lat":52,"lon":51},[80],{"name":81,"role":38,"phone":22,"phoneExt":22,"email":22},"Ligen Liu",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Liu Ligen","director","100495882","phase-2-adaptive-treatment-for-acute-myeloid-leukemia-based-on-d14-mrd-results-100495882",false,"NCT05736978","Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results","Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study","AVS","Inclusion Criteria:\n\n* Known and written informed consent voluntarily\n* Age ≥ 18 years\n* Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:\n\n  * 75 years or Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction \\\u003C= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) \\\u003C= 65% or Forced Expiratory Volume in 1 second (FEV1) \\\u003C= 65%; Creatinine clearance \\>= 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin; Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .\n* Liver function meets the following criteria: aspartate aminotransferase (AST) ≤ 3.0×ULN\\*; alanine aminotransferase (ALT) ≤3.0×ULN\\*; Bilirubin≤1.5×ULN\\*; For subjects \\\u003C75 years old, the bilirubin level can be ≤3.0×ULN; Unless due to leukemic organ involvement.\n* Renal function meets the following criteria: creatinine clearance ≥ 30 mL\u002Fmin (Cockroft-Gault formula)\n* Life expectancy ≥ 4 weeks\n\nExclusion Criteria:\n\n* History of any malignancies prior to study entry with exception noted in the protocol.\n* Participant has known HIV infection, active hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) .\n* Participant has known active central nervous system (CNS) involvement with AML.\n* Must not have received prior anti-AML treatment except for hydroxyurea","ALL","18 Years",{"count":97,"type":98},58,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.",[104,105],"AML","MRD",[107,108,109],"untreated AML","MRD results","selinexor","2023-03-13",{"date":112,"type":113},"2023-03-15","ACTUAL",{"date":115,"type":98},"2023-03-31",{"date":117,"type":98},"2027-03-15",{"name":5,"class":6},4]