[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491717":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":19,"responsibleParty":40,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":22,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Sichuan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chidamide","EXPERIMENTAL",null,[13],"Drug: Chidamide",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","initial time：platelet count ≥50×10\\^9\u002FL after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10\\^9\u002FL-increased by 5 mg 20×10\\^9\u002FL≤ platelet count \\\u003C50×10\\^9\u002FL-remains unchanged platelet count \\\u003C50×10\\^9\u002FL- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT",[9],[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"West China Hospital of Sichuan University","RECRUITING","Chengdu","Sichuan","610044","China","CN",{"type":29,"coordinates":30},"Point",[31,32],104.06667,30.66667,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Jie Ji, MD","CONTACT","86-28-85422370","jieji@scu.edu.cn",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jie Ji","Principle Investigator","100491717","phase-1-chidamide-prevents-recurrence-of-high-risk-aml-after-allo-hsct-100491717",false,"NCT05682755","Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT","Chidamide Prevents the Recurrence of High-risk Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Single-centered, Single-arm, Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);\n2. KPS score \\> 60 or ECOG score 0-2;\n3. The expected survival period \\> 3 months;\n4. Received allo-HSCT and achieved complete remission (CR);\n5. Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10\\^9\u002FL for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\\^9\u002FL for 7 consecutive days without platelet transfusion, Hb ≥ 80 g \u002FL without red blood cell transfusion); and neutrophil count ≥ 1.5×10\\^9\u002FL, platelet count ≥ 50×10\\^9\u002FL within 45 days after transplantation;\n6. No central nervous system involvement or clinical symptoms after transplantation;\n7. Those who have no serious functional damage to important organs of the body;\n8. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;\n9. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;\n2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;\n3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;\n4. Poor graft function (PGF) occurred after allo-HSCT;\n5. Combined with other malignant tumors and require treatment;\n6. Active GVHD;\n7. Have a history of allergy to Chidamide;\n8. Pregnant or lactating females;\n9. Patients with known history of human immunodeficiency virus (HIV) virus infection and\u002For acquired immunodeficiency syndrome;\n10. Patients with active chronic hepatitis B or active hepatitis C;\n11. History of prolonged QT syndrome;\n12. Patients considered by other researchers to be unsuitable for this study.","ALL","18 Years","65 Years",{"count":55,"type":56},77,"ESTIMATED","INTERVENTIONAL",[59,60],"PHASE1","PHASE2","The goal of this phase I\u002FII clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:\n\n• The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT.\n\nParticipants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.",[63],"Leukemia, Myeloid, Acute","2022-12-27",{"date":66,"type":67},"2023-01-12","ACTUAL",{"date":69,"type":67},"2022-12-22",{"date":71,"type":56},"2026-12-31",{"name":5,"class":6},1]