[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460021":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":64,"collaborators":40,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":40,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":40,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Azacitidine combined with Chidamide","EXPERIMENTAL","Patients will recieve six courses of azacitidine 50mg\u002Fm2 through a needle under your skin on Days 1-3.Each course is 28 days long.At the same time patients will recieve oral chidamide 5mg per day for no more than 2 years.",[13,14],"Drug: Azacitidine","Drug: Chidamide",[16,26],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Azacitidine","Patients will recieve six courses of azacitidine 50mg\u002Fm2 through a needle under skin on Days 1-3.Each course is 28 days long.",[9],[22,23,24,25],"5-Azacitidine","5-aza","Vidaza","5-AZC",{"type":17,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Chidamide","Patients will recieve oral chidamide 5mg per day for no more than 2 years.",[9],[31],"Epidaza",[33],{"name":34,"affiliation":5,"role":35},"Rui Huang, Doctor","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+8615918528317",null,"Rachelchn@163.com",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Yunqing Wang, Bachelor","+8618585509970","Wangyun7q@163.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Nanfang Hospital of Southern Medical University","RECRUITING","Guanzhou","Guandong","510250","China","CN",{"type":56,"coordinates":57},"Point",[58,59],109.01843,28.41559,{"lat":59,"lon":58},[62,63],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},{"type":65,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100460021","phase-1-single-arm-study-of-post-transplant-azacitidine-and-chidamide-for-prevention-of-acute-myelogenous-leukemia-relapse-100460021",false,"NCT05270200","Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse","To Evaluate Safety and Efficiency of AZA Combined With Chidamide as Maintenance Therapy in High-risk Acute Myeloid Leukemia Patients After Allogeneic Hematopoietic Stem Cell Transplantation：A Multicenter, Single-arm Study","Inclusion Criteria:\n\n* 1.Age 18 to 60 years old,both male and female\n* 2.Be able to understand and sign informed consent\n* 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic\n* 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML\n* 5.Patients with an ECOG performance status 0,1,2 or 3\n* 6.Expected survival time ≥ 3 months\n* 7.Non-hematological toxicity related to transplantation does not exceed Grade 2\n* 8.Laboratory indicators meet the following standards:\n\n  1. 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal.\n  2. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10\u002FL and without G-CSF treatment.\n  3. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10\u002FL and without platelet transfusion.\n  4. Serum creatinine clearance rate is greater than 30ml\u002Fmin.\n\nExclusion Criteria:\n\n* 1.Uncontrollable active infection\n* 2.Patients with active hepatitis B or C or HIV infection before enrollment\n* 3.Have a grade III-IV graft-versus-host disease","ALL","18 Years","60 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.",[85],"Leukemia, Myeloid, Acute",[87,88,89,18,27,90],"Acute myelogenous leukemia","Allogenetic stem cell transplant","Maintenance therapy","High-risk AML","2025-09-21",{"date":93,"type":94},"2025-09-25","ACTUAL",{"date":96,"type":94},"2022-02-01",{"date":98,"type":78},"2027-12-31",{"name":5,"class":6},1]