[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462759":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":49,"collaborators":51,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":30,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The First Affiliated Hospital of Xiamen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"venetoclax combining chidamide and azacitidine (VCA)","EXPERIMENTAL","28 days per cycle × at least 2 cycles；\n\n1\\) chidamide 30mg biw × 2weeks；2) venetoclax 200mg\u002Fd × 2 weeks 3) azacitidine 100mg\u002Fd d1-7",[13],"Drug: venetoclax combining chidamide and azacitidine (VCA)",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","information already included in arm\u002Fgroup descriptions",[9],[20],"VCA",[22],{"name":23,"affiliation":5,"role":24},"Bing Xu","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Bing Xu, M.D.","CONTACT","+865922137255",null,"xubingzhangjian@126.com",[33],{"facility":23,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Xiamen","Fujian","361003","China","CN",{"type":41,"coordinates":42},"Point",[43,44],118.08187,24.47979,{"lat":44,"lon":43},[47,48],{"name":23,"role":28,"phone":30,"phoneExt":30,"email":30},{"name":23,"role":24,"phone":30,"phoneExt":30,"email":30},{"type":50,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[52,54,57,60,62,64],{"name":53,"class":6},"Fujian Provincial Hospital",{"name":55,"class":56},"Fujian Cancer Hospital","OTHER_GOV",{"name":58,"class":59},"Zhangzhou manicipal hospital of Fujian Province","UNKNOWN",{"name":61,"class":6},"Jieyang People's Hospital",{"name":63,"class":56},"Dongguan People's Hospital",{"name":65,"class":6},"Huizhou Municipal Central Hospital","100462759","phase-2-venetoclax-combining-chidamide-and-azacitidine-vca-in-the-treatment-of-rr-aml-100462759",false,"NCT05305859","Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R\u002FR AML","A Multi-center, Prospective, Single-arm Study of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of Refractory\u002FRelapsed Acute Myelogenous Leukemia (R\u002FR AML)","Inclusion Criteria:\n\n* Age ≥18\n* Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology\n* ECOG：0-2\n* Life expectancy ≥ 3 months\n* Adequate laboratory parameters during the screening period as evidenced by the following:\n\n  1. Creatinine clearance≥30 mL\u002Fmin and serum Creatinine ≤ 160µmol\u002FL\n  2. ALT and AST ≤ 3 × upper limit of normal (ULN)\n  3. Able to understand and sign an informed consent form (ICF).\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Central nervous system leukemia\n* Uncontrolled or significant cardiovascular disease, including any of the following:\n\n  1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n  2. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);\n  3. 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  4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;\n  5. History of New York Heart Association Class 3 or 4 heart failure;\n  6. Complete left bundle branch block;\n  7. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;\n* Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;\n* Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease\n* Females who are pregnant or breastfeeding;\n* Mental disorders that hinder research participation\n* Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression\u002FGVHD treatment, it is not allowed)\n* Any other situation where the investigator believes that the patient should not participate in this trial","ALL","18 Years",{"count":76,"type":77},30,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and\u002For refractory AML",[83,84,85],"Leukemia, Myeloid, Acute","Relapsed Adult AML","Refractory Leukemia",[87],"refractory\u002Frelapsed acute myelogenous leukemia","2025-09-04",{"date":90,"type":91},"2025-09-11","ACTUAL",{"date":93,"type":91},"2022-01-12",{"date":95,"type":77},"2027-06-30",{"name":5,"class":6},1]