[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632526":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VA-CIG","EXPERIMENTAL","Patients are treated with VA-CIG chemotherapy regimen.",[13],"Drug: Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF","* Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Day 3, and 400 mg on Days 4-14, orally, once daily;\n* Azacitidine: 75 mg\u002Fm²\u002Fd, subcutaneous injection, on Days 1-7;\n* Cytarabine: 100 mg\u002Fm²\u002Fd, intravenous infusion, on Days 1-5;\n* Idarubicin: 6 mg\u002Fm²\u002Fd, intravenous infusion, on Days 1-3;\n* Human granulocyte colony-stimulating factor (G-CSF): 200 μg\u002Fm²\u002Fd, subcutaneous injection, from Day 0 until the white blood cell count \\> 10×10⁹\u002FL.\n\nOne cycle lasts for 28 days",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Dr. Gao Xiaoning, Chief Physician, Professor","CONTACT","86+01066947169","gaoxn@263.net",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Chinese PLA General Hospital","RECRUITING","Beijing","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":43,"phoneExt":20,"email":44},"Lei Xu","86-01066947174","xulei800@hotmail.com",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Xiao-Ning Gao","Chief Physician, Professor","100632526","phase-2-va-cig-regimen-for-previously-untreated-acute-myeloid-leukemia-a-multicenter-prospective-single-arm-trial-100632526",false,"NCT07514832","VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial","A Multicenter, Prospective, Single-Arm Clinical Trial of Venetoclax in Combination With Azacitidine, Cytarabine, Idarubicin and G-CSF (VA-CIG) for Patients With Previously Untreated Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML, excluding acute promyelocytic leukemia) confirmed by morphology, immunophenotyping and molecular genetics, in accordance with the WHO 2022 diagnostic criteria for AML;\n* Age 18-70 years, with no gender restriction;\n* No prior AML-related treatment has been received; exceptions are made for the use of hydroxyurea or similar agents during the diagnostic screening phase to control peripheral blood leukemic blasts;\n* Patients must be assessed as tolerable to intensive chemotherapy regimens; evaluation of tolerance to intensive chemotherapy shall be performed in accordance with the Ferrara 2013 criteria (Appendix A);\n* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* Serum creatinine ≤ 2.0 × upper limit of normal (ULN), or creatinine clearance \\> 40 mL\u002Fmin calculated by the Cockcroft-Gault formula for glomerular filtration rate (GFR);\n* Total bilirubin ≤ 2 × ULN, and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 × ULN;\n* Left ventricular ejection fraction (LVEF) ≥ 45%, or LVEF measured by echocardiography (ECHO) within the normal range;\n* Expected survival \\> 3 months.\n\nExclusion Criteria:\n\n* Subjects with a history of myeloproliferative neoplasms (MPNs), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and acute myeloid leukemia (AML) with BCR-ABL1 translocation;\n* Patients with a prior history of venetoclax or azacitidine (Aza) treatment for other diseases;\n* Known hypersensitivity to any component of the investigational medicinal products;\n* History of other concurrent malignancies within 2 years prior to enrollment, except:\n\nAdequately treated carcinoma in situ of the cervix or breast; Basal cell carcinoma or localized squamous cell carcinoma of the skin; Previously controlled malignancies treated with radical surgical resection (or other curative modalities), etc.\n\n* Presence of uncontrolled severe infection or active bleeding;\n* Pregnant or lactating women;\n* Subjects with active, treatment-uncontrolled viral infection caused by HIV, hepatitis B virus, or hepatitis C virus;\n* Subjects with evidence of central nervous system leukemia before treatment initiation;\n* Women of childbearing potential who do not agree to use at least one reliable contraceptive method from Day 1 of the study until 90 days after the last dose of study medication; sexually active male subjects who do not agree to use contraceptive measures from Day 1 of the study until 90 days after the last dose of study medication; male subjects who do not agree to refrain from sperm donation from the start of study drug administration until at least 90 days after the last dose;\n* Subjects with epilepsy requiring pharmacotherapy, dementia, or other abnormal psychiatric conditions that impair the ability to understand or comply with the study protocol;\n* Presence of psychiatric disorders or cognitive impairment that prevents cooperation with treatment and follow-up; conditions limiting oral drug intake or gastrointestinal absorption.","ALL","18 Years","70 Years",{"count":60,"type":61},48,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor \\[G-CSF\\]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.",[67],"AML (Acute Myeloid Leukemia)",[69,70,71,72],"AML","Venetoclax","chemotherapy","BCL2 inhibitor","2026-03-31",{"date":75,"type":76},"2026-04-07","ACTUAL",{"date":78,"type":61},"2026-04-15",{"date":80,"type":61},"2028-12-31",{"name":5,"class":6},1]