[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606180":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":40,"responsibleParty":111,"collaborators":113,"id":117,"slug":20,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":20,"enrollmentInfo":126,"targetDuration":20,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":43,"whyStopped":20,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VA alternating with low-CHA","EXPERIMENTAL","single treatment arm",[13],"Drug: Alternately treated with VA\u002Flow CHA regimen",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Alternately treated with VA\u002Flow CHA regimen","1. Induction Phase (4 alternating cycles):\n\n   Participants will receive 4 cycles of alternating therapy:\n   * VA Cycle:\n\n     * Venetoclax 400 mg PO daily on Days 1-28\n     * Azacitidine 75 mg\u002Fm² SC daily on Days 1-7\n   * Low-dose CHA Cycle:\n\n     * Cladribine 5 mg\u002Fm² IV daily on Days 1-3\n     * Homoharringtonine 1 mg\u002Fm² IV daily on Days 1-5\n     * Cytarabine 20 mg SC every 12 hours on Days 1-10 Alternating sequence: VA → CHA → VA → CHA → VA → CHA → VA → CHA\n2. Maintenance Phase (24 months):\n\nFollowing induction, participants will receive:\n\n* Venetoclax 400 mg PO daily on Days 1-28\n* Azacitidine 75 mg\u002Fm² SC daily on Days 1-7 Repeated every 28 days for 24 cycles.\n\nWe aimed to compare this clinical intervention with standard VA which is:\n\n* Venetoclax 400 mg PO daily on Days 1-28\n* Azacitidine 75 mg\u002Fm² SC daily on Days 1-7 Repeated every 28 days for at least 24 cycles.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Jie Dr. Sun, M.D, Ph.D","Bone Marrow Transplantation Center of The First Affiliated Hospital, Zhejiang University School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":29},"Shanshan Prof. Pei, Ph.D","Liangzhu Laboratory, Zhejiang University School of Medicine","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Jie Sun","CONTACT","+8615305714109","jsun1492@zju.edu.cn",{"name":37,"role":33,"phone":38,"phoneExt":20,"email":39},"Yuanyuan Dr. Zhu, M.D, Ph.D","86-13906514060","zhuyyzju@zju.edu.cn",[41,58,71,85,99],{"facility":42,"status":43,"city":44,"state":45,"zip":20,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Beijing Chao-Yang Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":56,"phoneExt":20,"email":57},"Honghu Zhu","86+010-85230000","zhuhhdoc@163.com",{"facility":59,"status":43,"city":60,"state":61,"zip":20,"country":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Shenzhen University General Hospital","Shenzhen","Guangdong",{"type":48,"coordinates":63},[64,65],114.0683,22.54554,{"lat":65,"lon":64},[68],{"name":69,"role":33,"phone":70,"phoneExt":20,"email":20},"Lixin Wang","86+13718000488",{"facility":72,"status":43,"city":73,"state":74,"zip":20,"country":46,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"the First Affiliated Hospital of Soochow University","Suzhou","Jiangsu",{"type":48,"coordinates":76},[77,78],120.59538,31.30408,{"lat":78,"lon":77},[81],{"name":82,"role":33,"phone":83,"phoneExt":20,"email":84},"Suning Chen","86+13656205608","chensuning@suda.edu.cn",{"facility":86,"status":43,"city":87,"state":88,"zip":20,"country":46,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"the Second Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":48,"coordinates":90},[91,92],115.85306,28.68396,{"lat":92,"lon":91},[95],{"name":96,"role":33,"phone":97,"phoneExt":20,"email":98},"Li Yu","86+0791-86120120","zengyulii@126.com",{"facility":100,"status":43,"city":101,"state":102,"zip":20,"country":46,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":48,"coordinates":104},[105,106],120.16142,30.29365,{"lat":106,"lon":105},[109],{"name":32,"role":33,"phone":110,"phoneExt":20,"email":35},"8615305714109",{"type":25,"investigatorFullName":32,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Principle Attending, Associated Professor",[114],{"name":115,"class":116},"AbbVie","INDUSTRY","100606180",false,"NCT07172204","Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML","The Efficacy and Safety of VA Alternating With Low-dose CHA in the Treatment of Newly Diagnosed Unfit AML: a Prospective, Multi-centers, Single Arm Phase II Study","CHANCE","Inclusion Criteria:\n\n* Understand the research and sign a written informed consent form;\n* Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment;\n* or unwilling to undergo IC. Ineligibility for IC is defined as meeting any of the following criteria:\n* Age ≥ 60 years\n* Age 18-59 years but ineligible for intensive chemotherapy (IC) , meet ≥1 of the following:\n\n  * Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening;\n  * Severe heart failure (congestive heart failure requiring treatment or myocardial infarction history with ejection fraction ≤50%);\n  * Severe pulmonary dysfunction (DLCO ≤65%, FEV1 ≤65%, dyspnea at rest, or oxygen dependence);\n  * Severe renal insufficiency requiring dialysis;\n  * Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin \\>1.5×ULN;\n* Mental illness requiring inpatient psychiatric treatment;\n* Any comorbidity deemed by physician to contraindicate IC.\n\nExclusion Criteria:\n\n* Diagnosis of: AML arising from chronic myeloid leukemia (CML); myeloid sarcoma; acute promyelocytic leukemia (APL) or presence of FLT3-ITD mutations;\n* Active malignancies (except adequately treated carcinoma in situ or basal cell carcinoma) within 2 years prior to Cycle 1 Day 1 (C1D1);\n* Major surgery or systemic anticancer therapy within 28 days before C1D1;\n* Known hypersensitivity to: Active pharmaceutical ingredients: cladribine, homoharringtonine, cytarabine, venetoclax, azacitidine; Any excipients in study drug formulations;\n* GI conditions impairing oral drug absorption: Dysphagia; short-gut syndrome; gastroparesis or related disorders;\n* Uncontrolled active infection;\n* Controlled infection permitted if: Afebrile (\\\u003C38°C) and hemodynamically stable (SBP \\>90 mmHg, HR \\\u003C100 bpm) for ≥72 hours pre-C1D1; on non-interacting antimicrobial regimen; active HBV\u002FHCV infection (Chronic carriers require PI approval with viral load monitoring); HIV-positive patients receiving HAART;\n* Pregnancy\u002Flactation or refusal of contraception: Negative serum β-hCG within 24h pre-C1D1;\n* Psychiatric disorders or social circumstances compromising protocol compliance;\n* Prior AML-directed therapy except: cytoreduction for hyperleukocytosis per institutional guidelines (hydroxyurea, leukapheresis); supportive growth factors;","ALL","18 Years",{"count":127,"type":128},25,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","This phase II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.",[134,135,136],"Intensive Chemotherapy Unfit","Newly Diagnosed Acute Myeloid Leukemia (AML)","Age ≥60",[138,139,140,141,142,143,144,145],"Acute Myeloid Leukemia","Venetoclax","alternating","Homoharringtonine","Cladribine","age 60 and older","intensive chemotherapy unfit","newly diagnosed","2026-02-02",{"date":148,"type":149},"2026-02-04","ACTUAL",{"date":151,"type":149},"2025-09-16",{"date":153,"type":128},"2029-07-31",{"name":5,"class":6},5]