[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intensive-chemotherapy-unfit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intensive-chemotherapy-unfit":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Intensive Chemotherapy Unfit","Newly Diagnosed Acute Myeloid Leukemia (AML)","Age ≥60",[30,31,32,33,34,35,36,37],"Acute Myeloid Leukemia","Venetoclax","alternating","Homoharringtonine","Cladribine","age 60 and older","intensive chemotherapy unfit","newly diagnosed","RECRUITING","2026-02-02",{"date":41,"type":42},"2026-02-04","ACTUAL",{"date":44,"type":42},"2025-09-16",{"date":46,"type":20},"2029-07-31",{"name":48,"class":49},"First Affiliated Hospital of Zhejiang University","OTHER",5,""]