[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606180":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":40,"responsibleParty":112,"collaborators":114,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":20,"enrollmentInfo":128,"targetDuration":20,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":43,"whyStopped":20,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"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",[41,59,72,86,100],{"facility":42,"status":43,"city":44,"state":45,"zip":20,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Beijing Chao-Yang Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":20,"email":58},"Honghu Zhu","86+010-85230000","zhuhhdoc@163.com",{"facility":60,"status":43,"city":61,"state":62,"zip":20,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Shenzhen University General Hospital","Shenzhen","Guangdong",{"type":49,"coordinates":64},[65,66],114.0683,22.54554,{"lat":66,"lon":65},[69],{"name":70,"role":33,"phone":71,"phoneExt":20,"email":20},"Lixin Wang","86+13718000488",{"facility":73,"status":43,"city":74,"state":75,"zip":20,"country":46,"countryCode":47,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"the First Affiliated Hospital of Soochow University","Suzhou","Jiangsu",{"type":49,"coordinates":77},[78,79],120.59538,31.30408,{"lat":79,"lon":78},[82],{"name":83,"role":33,"phone":84,"phoneExt":20,"email":85},"Suning Chen","86+13656205608","chensuning@suda.edu.cn",{"facility":87,"status":43,"city":88,"state":89,"zip":20,"country":46,"countryCode":47,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"the Second Affiliated Hospital of Nanchang University","Nanchang","Jiangxi",{"type":49,"coordinates":91},[92,93],115.85306,28.68396,{"lat":93,"lon":92},[96],{"name":97,"role":33,"phone":98,"phoneExt":20,"email":99},"Li Yu","86+0791-86120120","zengyulii@126.com",{"facility":101,"status":43,"city":102,"state":103,"zip":20,"country":46,"countryCode":47,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":49,"coordinates":105},[106,107],120.16142,30.29365,{"lat":107,"lon":106},[110],{"name":32,"role":33,"phone":111,"phoneExt":20,"email":35},"8615305714109",{"type":25,"investigatorFullName":32,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Principle Attending, Associated Professor",[115],{"name":116,"class":117},"AbbVie","INDUSTRY","100606180","phase-2-alternating-regimen-of-va-and-low-dose-cha-in-the-treatment-of-unfit-newly-diagnosed-aml-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":129,"type":130},25,"ESTIMATED","INTERVENTIONAL",[133],"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.",[136,137,138],"Intensive Chemotherapy Unfit","Newly Diagnosed Acute Myeloid Leukemia (AML)","Age ≥60",[140,141,142,143,144,145,146,147],"Acute Myeloid Leukemia","Venetoclax","alternating","Homoharringtonine","Cladribine","age 60 and older","intensive chemotherapy unfit","newly diagnosed","2026-02-02",{"date":150,"type":151},"2026-02-04","ACTUAL",{"date":153,"type":151},"2025-09-16",{"date":155,"type":130},"2029-07-31",{"name":5,"class":6},5]