[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557010":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":56,"centralContacts":61,"locations":67,"responsibleParty":84,"collaborators":87,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":65,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":65,"enrollmentInfo":109,"targetDuration":65,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":69,"whyStopped":65,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"VA group","ACTIVE_COMPARATOR","Azacitidine 75mg\u002Fm2 subcutaneous daily for 7 days and Venetoclax orally once daily (100mg d1, 200mg d2, 400mg d3-28). Patients received 2 cycles of VA, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the result is partial remission (PR)\u002Fno response (NR) at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is complete remission (CR)\u002FCR with incomplete hematologic recovery (CRi)\u002Fmorphologic leukemia-free state (MLFS), the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease.",[13],"Drug: VA",{"label":15,"type":16,"description":17,"interventionNames":18},"VACl group","EXPERIMENTAL","Azacitidine 75mg\u002Fm2 subcutaneous Daily for 7 days, Venetoclax orally once daily (100 mg d1, 200mg d2, 400mg d3-28) and Cladribine 5mg\u002Fm2 intravenous (IV) over approximately 1 to 2 hours, daily on days 1-3. Patients received 2 cycles of VACl treatments, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR\u002FNR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR\u002FCRi\u002FMLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease.",[19],"Drug: VACl",{"label":21,"type":16,"description":22,"interventionNames":23},"VACh group","Azacitidine 75mg\u002Fm2 subcutaneous daily for 7 days, Venetoclax orally once daily (100mg d1, 200mg d2, 400mg d3-28) and Chidamide 10mg orally daily for 12 days. Patients received 2 cycles of VACh treatments, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR\u002FNR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR\u002FCRi\u002FMLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the same regimen until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease.",[24],"Drug: VACh",{"label":26,"type":16,"description":27,"interventionNames":28},"VACl Alternating With VACh group","Patients received 1 cycle of VACl and 1 cycle of VACh treatment, the bone marrow aspirate will be done on the 21-28th day in the each cycle. If the bone marrow assessment is PR\u002FNR at the end of the cycle 2, the patients need to withdraw from the trial. If the bone marrow assessment is CR\u002FCRi\u002FMLFS, the patients will start post-remission therapy. For post-remission therapy, if the patients ineligible for intensive chemotherapy or declines, continue with the VACl alternating with VACh until progression or recurrence of the disease, and the patients need to withdraw from the trial. If the patients fit for intensive chemotherapy, patients will receive consolidation chemotherapy with other regimens or transplantation, and the patients need to withdraw from the trial if progression or recurrence of the disease.",[29],"Drug: VACl Alternating With VACh",[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","VACl","Azacitidine:75mg\u002Fm2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg\u002Fm2 IV over approximately 1 to 2 hours, daily on days 1-3.",[15],[37],"Venetoclax+Azacitidine+Cladribine",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"VACh","Azacitidine: 75mg\u002Fm2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days",[21],[43],"Venetoclax+Azacitidine+Chidamide",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"VACl Alternating With VACh","VACl:\n\nAzacitidine:75mg\u002Fm2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100 mg d1, 200mg d2, 400mg d3-28) Cladribine: 5mg\u002Fm2 IV over approximately 1 to 2 hours, daily on days 1-3.\n\nVACh:\n\nAzacitidine: 75mg\u002Fm2 Subcutaneous daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28) Chidamide: 10mg orally daily for 12 days",[26],[49],"Venetoclax+Azacitidine+Cladribine alternating with Venetoclax+Azacitidine+Chidamide",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"VA","Azacitidine: 75mg\u002Fm2 Subcutaneous (SC) daily for 7 days Venetoclax: orally once daily (100mg d1, 200mg d2, 400mg d3-28).",[9],[55],"Venetoclax+Azacitidine",[57],{"name":58,"affiliation":59,"role":60},"Sheng-Li Xue, M.D.","The First Affliated Hospital of Soochow University","PRINCIPAL_INVESTIGATOR",[62],{"name":58,"role":63,"phone":64,"phoneExt":65,"email":66},"CONTACT","008651267781139",null,"slxue@suda.edu.cn",[68],{"facility":59,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Suzhou","Jiangsu","215006","China","CN",{"type":76,"coordinates":77},"Point",[78,79],120.59538,31.30408,{"lat":79,"lon":78},[82],{"name":58,"role":63,"phone":83,"phoneExt":65,"email":66},"+8651267781139",{"type":60,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Sheng-Li Xue, MD","professor",[88,90,92,94,96,98],{"name":89,"class":6},"Jining Medical University",{"name":91,"class":6},"Qilu Hospital of Shandong University",{"name":93,"class":6},"The Affiliated Hospital of Qingdao University",{"name":95,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":97,"class":6},"Tongji Hospital",{"name":99,"class":6},"The First Affiliated Hospital of Bengbu Medical University","100557010","phase-2-comparison-of-va-venetoclax-azacitidine-vacl-va-cladribine-vach-va-chidamide-and-alternating-vaclvach-in-newly-diagnosed-acute-myeloid-leukemia-100557010",false,"NCT06532552","Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl\u002FVACh in Newly Diagnosed Acute Myeloid Leukemia","Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl\u002FVACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria within 21 days prior to randomization.\n\n1. Subject must have confirmation of previously untreated AML by World Health Organization (WHO) criteria, and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities. Prior therapy with hydroxyurea or a total dose of cytarabine no more than 0.5g (for emergency use for stabilization) is allowed.\n2. Subject must be≥18 years of age with at least one of the following conditions:\n\n   A)≥60 years of age; B) Patients aged \\\u003C 60 years who are unsuitable for standard induction therapy（Any other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy); C) The patient refused the conventional intensive chemotherapy.\n3. Adequate organ function as defined below:\n\n   A)liver function (bilirubin≤2mg\u002FdL, aspartate transaminase (AST) and\u002For alanine transaminase (ALT)≤3 x ULN).\n\n   Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration.\n\n   B)kidney function (creatinine≤1.5xULN ).\n4. ECOG performance status of ≤ 2.\n5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n7. Patient must have a projected life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Subject has a history of other malignancies prior to study entry, with the exception of:\n\n   A) Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; B) Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; C) Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n2. Subject has acute promyelocytic leukemia, subject has history of myeloproliferative neoplasm \\[MPN\\] including myelofibrosis, essential thrombocythemia, polycythemia vera, CML with or without BCR-ABL1 translocation, BCR\u002FABL positive AML.\n3. Patient has known active central nervous syster (CNS) involvement with AML.\n4. Subject has a white blood cell count\\> 25×10\\^9\u002FL. (Hydroxyurea is permitted to meet this criterion.)\n5. Prior therapy with venetoclax, Cladribine, hypomethylating agents (HMAs), Chidamide or Chimeric Antigen Receptor T cell therapy, experimental therapies for MDS or AML.\n6. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.\n7. Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required.)\n8. Subject has received strong and\u002For moderate CYP3A inducers within 7 days prior to the initiation of study treatment.\n9. Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.\n10. Subject has a cardiovascular disability status of New York Heart Association Class≥2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.\n11. Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his\u002Fher participating in this study.\n12. Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).\n13. Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., HBs Ag-, and anti-HBs+-\\] may participate)","ALL","18 Years",{"count":110,"type":111},172,"ESTIMATED","INTERVENTIONAL",[114],"PHASE2","This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.",[117,118],"Acute Myeloid Leukemia, Adult","Newly Diagnosed",[120,121,122,123],"Venetoclax","Azacitidine","Cladribine","Chidamide","2025-11-18",{"date":126,"type":127},"2025-11-19","ACTUAL",{"date":129,"type":127},"2024-07-29",{"date":131,"type":111},"2028-08-01",{"name":5,"class":6},1]