[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649359":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":49,"centralContacts":53,"locations":29,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":29,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":29,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":91,"whyStopped":29,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":29},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"CMG+VEN","EXPERIMENTAL","Patients who achieve complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) following Cycle 1 will proceed to consolidation therapy.\n\nPatients achieving a partial response (PR) or a ≥50% reduction in bone marrow blasts after Cycle 1 will receive one additional cycle of re-induction therapy with the same CMG+Ven regimen (venetoclax 400 mg daily on Days 1-7).\n\nThose who subsequently attain CR, CRh, CRi, or MLFS after Cycle 2 will proceed to consolidation therapy.\n\nPatients with no response (NR) after Cycle 1, or with NR or PR after Cycle 2, will discontinue study treatment.",[13,14,15,16],"Drug: Mitoxantrone Hydrochloride Liposome","Drug: Cytarabine","Drug: Granulocyte Colony-Stimulating Factor(G-CSF)","Drug: Venetoclax",{"label":18,"type":19,"description":20,"interventionNames":21},"VA","ACTIVE_COMPARATOR","Patients who achieve complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) following Cycle 1 will proceed to consolidation therapy.\n\nPatients achieving a partial response (PR) or a ≥50% reduction in bone marrow blasts after Cycle 1 will receive one additional cycle of re-induction therapy with the same VA regimen.\n\nThose who subsequently attain CR, CRh, CRi, or MLFS after Cycle 2 will proceed to consolidation therapy.\n\nPatients with no response (NR) after Cycle 1, or with NR or PR after Cycle 2, will discontinue study treatment.",[16,22],"Drug: azacitidine",[24,30,34,38,42,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Mitoxantrone Hydrochloride Liposome","Mitoxantrone Hydrochloride Liposome: 15 mg\u002Fm², administered by intravenous drip (ivgtt) on day 1",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Cytarabine","Cytarabine: 10 mg\u002Fm², administered subcutaneously (H) every 12 hours (q12h) on days 1-7",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Granulocyte Colony-Stimulating Factor(G-CSF)","G-CSF: 5 μg\u002Fkg, administered subcutaneously (H) starting from day 0, and discontinued when WBC ≥ 20×10\\^9\u002FL",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Venetoclax","Venetoclax: 100 mg on day 2, 200 mg on day 3, and 400 mg on days 4-10, administered orally (po)",[9],{"type":25,"name":39,"description":43,"armGroupLabels":44,"otherNames":29},"Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-21 or 3-28, administered orally (po)",[18],{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":29},"azacitidine","Azacitidine: 75 mg\u002Fm\\^2, administered subcutaneously (H) on days 1-7.",[18],[50],{"name":51,"affiliation":5,"role":52},"Sujiang Zhang","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":29,"email":58},"Xiaoqian Xu","CONTACT","13816205940","Ellenxxq@qq.com",{"type":60,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[62],{"name":63,"class":64},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY","100649359","phase-3-mitoxantrone-hydrochloride-liposome-cytarabine-g-csf-plus-venetoclax-vs-azacitidine-plus-venetoclax-for-mds-ib2-and-secondaryelderly-aml-100649359",false,"NCT07735117","Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary\u002FElderly AML","A Prospective, Multicenter, Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome, Subcutaneous Cytarabine and G-CSF Combined With Venetoclax Versus Azacitidine Combined With Venetoclax in the Treatment of MDS-IB2 and Newly Diagnosed Adult Secondary or Elderly AML","Inclusion Criteria:\n\n* 1\\. The patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).\n\n  2\\. Age: 18-75 years inclusive. 3. Patients with clinically confirmed adult AML or MDS-IB2 (according to WHO 2022 criteria or ICC 2022 criteria). AML patients must meet any of the following:\n  1. Therapy-related AML\n  2. Prior history of MDS\n  3. Presence of MDS-related genetic\u002Fchromosomal abnormalities\n  4. Prior history of CMML\n  5. Age ≥ 60 years\n  6. Prior history of antecedent MPN (including ET, PV, and MF) with bone marrow fibrosis ≤ grade 2 (on a 0-3 grade scale) 4. For elderly AML patients, comprehensive assessment must show they belong to the Fit population: ECOG \\\u003C 3, CCI ≤ 0, and MMSE and SPPB assessment results meeting the Fit population criteria.\n\n     5\\. Liver and kidney function: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver infiltration); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver infiltration); serum creatinine ≤ 1.5 × ULN.\n\n     6\\. Expected survival ≥ 3 months. 7. Prior MDS-related therapy (excluding blood transfusions) must be completed at least 2 weeks before the start of study treatment. In cases of rapidly proliferative disease, hydroxyurea is permitted up to 24 hours before the start of study treatment. Toxicities from prior MDS therapy must have recovered to Grade 2 or lower before the start of study treatment.\n\n     Exclusion Criteria:\n* Patients who meet any of the following criteria will be excluded from the study:\n\n  1. Prior anti-cancer treatment history meeting any of the following:\n\n     1. Prior treatment with mitoxantrone or mitoxantrone liposome.\n     2. Prior treatment with venetoclax or hypomethylating agents.\n     3. Prior treatment with doxorubicin or other anthracyclines, with a cumulative doxorubicin dose \\> 360 mg\u002Fm\\^2 (for other anthracyclines, 1 mg doxorubicin is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin).\n     4. Received anti-cancer treatment including surgery, chemotherapy, targeted therapy, etc., or participated in another clinical trial with investigational drug within 4 weeks or 5 half-lives before the first dose of study drug.\n  2. Cardiac function or disease meeting any of the following:\n\n     1. Long QTc syndrome or QTc interval \\> 480 ms.\n     2. Complete left bundle branch block, second-degree or third-degree atrioventricular block.\n     3. Severe, uncontrolled arrhythmia requiring medication.\n     4. New York Heart Association (NYHA) Class ≥ II.\n     5. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n     6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months before enrollment, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n  3. Concurrent uncontrolled malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, carcinoma in situ of breast\u002Fcervix, or other malignancies that have been effectively controlled without treatment for \\> 6 months and patients receiving long-term non-chemotherapy treatment (e.g., hormone therapy).\n  4. Uncontrolled systemic disease (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus).\n  5. Central nervous system (CNS) leukemia.\n  6. Secondary AML with bone marrow fibrosis ≥ grade 3.\n  7. Blast crisis of chronic myeloid leukemia (CML).\n  8. AML with favorable-risk karyotypes: t(8;21)(q22;q22.1) RUNX1::RUNX1T1, inv(16)(p13.1q22) CBFB::MYH11, or acute promyelocytic leukemia (APL).\n  9. Human immunodeficiency virus (HIV) infection (HIV antibody positive).\n  10. Active hepatitis B or hepatitis C infection (HBsAg or HBcAb positive with HBV-DNA \\> 1×10\\^3 copies\u002FmL; HCV antibody positive with HCV-RNA \\> 1×10\\^3 copies\u002FmL).\n  11. Known immediate or delayed hypersensitivity reaction to the study drug's class or excipients.","ALL","18 Years","75 Years",{"count":76,"type":77},168,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","This study aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, subcutaneous cytarabine and G-CSF combined with venetoclax (CMG+Ven) versus azacitidine combined with venetoclax (VA) in the treatment of adult myelodysplastic syndrome IB2 (MDS-IB2) and newly diagnosed secondary or elderly AML.",[83,84],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndromes (MDS)",[86,87,88,31,89,39,90],"Acute myeloid leukemia","Myelodysplastic Syndromes","mitoxantrone hydrochloride liposome","Granulocyte Colony-Stimulating Factor","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-26",{"date":94,"type":95},"2026-07-29","ACTUAL",{"date":97,"type":77},"2026-07-30",{"date":99,"type":77},"2029-07-31",{"name":5,"class":6}]