[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522607":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":68,"collaborators":71,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":41,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":41,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Venetoclax Combined With CACAG Regimen","EXPERIMENTAL","Venetoclax combined with CACAG regimen for relapsed\u002Frefractory AML. Recipients were randomized and those entering the experimental group received azacytidine,cytarabine,aclacinomycin,chidamide,venetoclax and granulocyte colony-stimulating factor. Azacytidine was used as 75 mg\u002Fm2\u002Fday from day 1 to day 7.Cytarabine was used as 75-100 mg\u002Fm2 bid from day 1 to day 5. Aclacinomycin was used as 20 mg\u002Fday on days 1,3,5. Chidamide was used as 30 mg\u002Fday on days 1,4,8,11. Venetoclax was used as 400 mg\u002Fday from day 1 to day 14.Granulocyte colony-stimulating factor was used as 300 ug\u002Fday from day 0 until agranulocytosi recovery.",[13],"Drug: Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor",{"label":15,"type":16,"description":17,"interventionNames":18},"Best-Available Therapy(BAT) Regimen","ACTIVE_COMPARATOR","BAT regimen for relapsed\u002Frefractory AML.Recipients were randomized and those entering this group received FLAG\u002FCLAG\u002FMAE\u002FDCAG\u002FHAA\u002FHAD regimen.",[19],"Drug: Best-Available Therapy(BAT) Regimen",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor","1. Azacytidine (75mg\u002Fm2\u002Fday, days 1 to 7).\n2. Cytarabine (75-100mg\u002Fm2 q12h, days 1 to 5).\n3. Aclacinomycin(20mg\u002Fday, days 1,3,5).\n4. Chidamide(30mg\u002Fday , days 1,4,8,11).\n5. Venetoclax (100mg on day 1,200mg on day 2,400mg on days 3-14).\n6. Granulocyte colony stimulating factor (300 μg\u002Fday, day 0 until agranulocytosis recovery)",[9],[27],"CACAG+VEN",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"1. FLAG regimen:Fludarabine(30mg\u002Fm2,days 1-5)+Cytarabine (1-2g\u002Fm2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug\u002Fday,days 0 to 5)\n2. CLAG regimen:Cladribine(5mg\u002F2,days 1-5)+Cytarabine (1-2g\u002Fm2 applied 4h after fludarabine, days 1 to 5)+Granulocyte colony-stimulating factor(300ug\u002Fday,days 0 to 5)\n3. MAE regimen:Mitox(10mg\u002Fm2,days 1 to 5)+VP-16(100mg\u002Fm2,days 1 to 5)+Cytarabine (100-150mg\u002Fm2,days 1 to 7)\n4. DCAG regimen:Decitabine(20mg\u002Fm2,days 1 to 5)+Aclacinomycin(20mg\u002Fday on days 1,3,5)+Cytarabine (100mg q12h,days 1 to 5)+Granulocyte colony-stimulating factor(300 ug\u002Fday,day 0 until agranulocytosi recovery)\n5. HAA regimen:HHT(2mg\u002Fm2,days 1 to 7)+Aclacinomycin(20mg\u002Fday,days 1 to 7) and Cytarabine (100-200 mg\u002Fm2, days 1 to 5);\n6. HAD regimen:HHT(2mg\u002Fm2,days 1 to 7)+Daunorubicin(45mg\u002Fm2\u002Fday,days 1 to 3)+Cytarabine (100-200 mg\u002Fm2,days 1 to 5).",[15],[32],"FLAG\u002FCLAG\u002FMAE\u002FDCAG\u002FHAA\u002FHAD Regimen",[34],{"name":35,"affiliation":5,"role":36},"Daihong Liu, doctor","STUDY_CHAIR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","+8613681171597",null,"daihongrm@163.com",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Liping Dou, doctor","+8613681207138","lipingruirui@163.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62,64,66],{"name":35,"role":39,"phone":63,"phoneExt":41,"email":42},"86-13681171597",{"name":44,"role":39,"phone":65,"phoneExt":41,"email":46},"86-13681207138",{"name":35,"role":67,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Daihong Liu","doctor",[72,74,76,78,80,82,84,87],{"name":73,"class":6},"940 Hospital of the People's Liberation Army Joint Logistic Support Force",{"name":75,"class":6},"The General Hospital of Western Theater Command",{"name":77,"class":6},"The General Hospital of Northern Theater Command",{"name":79,"class":6},"960th Hospital of Joint Logistics Support Force of People's Liberation Army of China",{"name":81,"class":6},"Air Force Military Medical University, China",{"name":83,"class":6},"Yantai Yuhuangding Hospital",{"name":85,"class":86},"People's Liberation Army (PLA) Strategic Support Force Characteristic Medical Center","UNKNOWN",{"name":88,"class":6},"First Hospital of China Medical University","100522607","phase-2-clinical-study-of-venetoclax-combined-with-cacag-regimen-in-the-treatment-of-relapsedrefractory-acute-myeloid-leukemia-100522607",false,"NCT06084819","Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","A Prospective,Randomized,and Comparative Study on the Efficacy of Venetoclax Combined With CACAG Regimen and BAT Regimen in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patients who are able to understand and willing to sign the informed consent form (ICF).\n* All patients should aged 14 to 75 years,no gender limitation.\n* Patients with R\u002FR AML, diagnosed in accordance with the 2021 edition of the CMA criteria\n* Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;\n* Renal function: creatinine ≤the upper limit of normal;\n* Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;\n* The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.\n* Patients without severe allergic constitution.\n\nExclusion Criteria:\n\n* Patients with allergy or contraindication to the study drug;\n* Female patients who are pregnant or breast-feeding.\n* Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;\n* Patients with mental illness or other states unable to comply with the protocol;\n* Less than 6 weeks after surgical operation of important organs.\n* Liver function: ALT and AST\\>2.5 times the upper limit of normal ,bilirubin\\>2 times the upper limit of normal;Renal function: creatinine \\>the upper limit of normal;\n* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)","ALL","14 Years","75 Years",{"count":100,"type":101},200,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed\u002Frefractory acute myeloid leukemia.",[107],"Relapsed\u002FRefractory Acute Myeloid Leukemia",[107],"2026-03-29",{"date":111,"type":112},"2026-04-02","ACTUAL",{"date":114,"type":112},"2023-08-01",{"date":116,"type":101},"2030-01-31",{"name":5,"class":6},1]