[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intermediate-risk-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intermediate-risk-acute-myeloid-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100644626","phase-2-va-consolidation-in-intermediate-risk-aml-100644626",false,"NCT07672262","VA Consolidation in Intermediate-Risk AML","A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Intermediate-Risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2022 classification criteria;\n* Age ≥ 18 years;\n* Classified as intermediate-risk based on European LeukemiaNet (ELN) 2022 prognostic risk stratification;\n* Achieved first complete remission (CR) or CR with incomplete hematologic recovery (CRi) after ≤ 2 cycles of Venetoclax + Azacitidine (VA) induction therapy;\n* Has a suitable donor and is planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n* ECOG performance status score 0 to 2\n* Adequate organ function: creatinine clearance ≥ 50 mL\u002Fmin; AST and ALT ≤ 3 × ULN; total bilirubin ≤ 2 × ULN; LVEF ≥ 50%; life expectancy \\> 8 weeks\n* Voluntarily signed informed consent form and able to comply with study requirements\n\nExclusion Criteria:\n\n* Clinically active cardiovascular disease (uncontrolled arrhythmia\u002Fhypertension, NYHA Class 3\u002F4 heart failure, myocardial infarction within 3 months)\n* Active central nervous system (CNS) leukemia or extramedullary infiltration\n* Other serious diseases limiting participation (e.g., severe infection, renal failure)\n* Known HIV infection or uncontrolled severe viral hepatitis\n* Pregnant or breastfeeding women\n* Inability to understand, comply with protocol, or sign informed consent\n* Any other conditions deemed unsuitable by the investigator","ALL","18 Years",{"count":19,"type":20},226,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial aims to compare the efficacy and safety of venetoclax-based consolidation therapy versus conventional consolidation chemotherapy (intermediate\u002Fhigh-dose cytarabine) in newly diagnosed adult patients with intermediate-risk acute myeloid leukemia (AML). Participants must have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[26,27,28],"Acute Myeloid Leukemia","Intermediate Risk Acute Myeloid Leukemia","Consolidation Therapy","RECRUITING","2026-06-19",{"date":32,"type":33},"2026-06-26","ACTUAL",{"date":35,"type":20},"2026-06-01",{"date":37,"type":20},"2030-06-01",{"name":39,"class":40},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":41},"100612909","phase-2-gilteritinib-plus-va-followed-by-consolidation-chemotherapy-in-newly-diagnosed-flt3-itd-aml-100612909","NCT07259707","Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML","A Single-Center, Prospective, Single-Arm Phase II Clinical Study of Consolidation With High-Dose Cytarabine Following Deep Molecular Remission Induced by Gilteritinib Plus VA Regimen in Newly Diagnosed Intermediate-Risk Fit AML Patients With FLT3-ITD Mutation","GANCE","Inclusion Criteria:\n\n* Each subject (or their legal representative) must sign an informed consent form (ICF) before any specific study procedures or tests, indicating that he\u002Fshe understands the purpose and procedures of the study and is willing to participate.\n* Age ≥ 18 years or reaching the legal minimum adult age (whichever is greater) and ≤ 60 years (at screening);\n* Newly diagnosed acute myeloid leukemia with FLT3-ITD mutation according to the European LeukemiaNet (ELN) 2022 diagnostic criteria (no VAF requirement), with no low-risk or high-risk genetic features as defined by ELN 2022.\n* ECOG performance status ≤ 2. Biochemical indicators must be within the following limits within 21 days before randomization and at baseline: ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 3× ULN; serum creatinine ≤ 2× ULN or CrCl ≥ 40 mL\u002Fmin. LVEF determined by echocardiography is within the normal range (LVEF \\> 50%).\n\nExclusion Criteria:\n\n* Diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive acute myeloid leukemia, or AML secondary to previous chemotherapy or radiotherapy.\n* History of other malignancies, except for adequately treated non-malignant skin melanoma, cured in situ tumors, or other solid tumors that have been treated and have had no evidence of disease for at least 2 years.\n* Assessed as unfit for intensive chemotherapy based on the following criteria: ECOG performance status ≥ 2 at screening; severe cardiac diseases (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina); severe pulmonary diseases (e.g., DLCO ≤ 65% or FEV1 ≤ 65%); creatinine clearance \\\u003C 45 ml\u002Fmin (calculated by Cockcroft-Gault equation), liver disease with total bilirubin \\> 1.5 times the normal upper limit (ULN); any other comorbidities deemed incompatible with intensive chemotherapy by the attending physician.\n* Uncontrolled fungal, bacterial, or viral infections.\n* Known active clinically relevant liver disease (e.g., active hepatitis B or C); known history of HIV infection (participants should undergo HIV testing before randomization).\n* History of allergy to any excipients in gilteritinib tablets.\n* Pregnant or breastfeeding women.\n* Other conditions deemed unsuitable for this study by the investigator.","59 Years",{"count":52,"type":20},25,[23],"This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation. It primarily seeks to answer:\n\n* What is the complete remission rate after initial induction with Gilteritinib, Venetoclax, and Azacitidine?\n* What are the survival rates and safety of subsequent high-dose cytarabine consolidation after two cycles of this induction therapy? As a single-arm study, outcomes will be compared against historical data from standard treatments (including transplant) to assess if the new strategy is equally or more effective.\n\nParticipants will:\n\n* Undergo three cycles of high-dose cytarabine consolidation after two cycles of induction therapy, contingent upon achieving deep FLT3-ITD molecular remission.\n* Start Gilteritinib maintenance therapy after consolidation if FLT3-ITD remains detectable, continuing until deep molecular remission is achieved again.",[26,56,27,57],"FLT3 Internal Tandem Duplication Positive","Fit Patients",[59,60,61,62,63,64],"acute myeloid leukemia","FLT3-ITD","Intermediate Risk","Fit","Gilteritinib","Deep molecular remission","2026-02-02",{"date":67,"type":33},"2026-02-04",{"date":69,"type":33},"2026-01-25",{"date":71,"type":20},"2029-12-31",{"name":73,"class":40},"First Affiliated Hospital of Zhejiang University",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":41},"100546367","phase-2-study-of-va-combined-with-haag-regimen-in-newly-diagnosed-intermediate-and-high-risk-aml-patients-100546367","NCT06394011","Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients","A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).\n2. Age 18-65.\n3. ECOG score: 0-2.\n4. No history of previous chemotherapy or target therapy.\n5. Serum total bilirubin \\\u003C= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) \\\u003C= 1.5 times ULN, aspartate aminotransferase (AST) \\\u003C=1.5 times ULN;\n6. Creatinine clearance rate \\>=30 mL\u002Fmin;\n7. Serum lipase \\\u003C= 1.5 times ULN, amylase \\\u003C= 1.5 times ULN;\n8. Capable to understand and willing to participate in this study, signed the informed consent form.\n\nExclusion Criteria:\n\n1. AML transformed with chronic myelogenous leukemia.\n2. Acute promyelocytic leukemia (type M3).\n3. Patients with a second malignancy requiring treatment.\n4. Patients with uncontrolled active infection.\n5. Patients with left ventricular ejection fraction \\\u003C 0.5 by echocardiography or grade III\u002FIV cardiovascular dysfunction according to the New York Heart Association Classification.\n6. Patients with hepatic and renal inadequacy: total serum bilirubin \\>=2.0 mg\u002Fdl, AST \\>=3 times ULN, serum creatinine clearance (Ccr) \\\u003C50 ml \u002F min.\n7. Patients with arterial oxygen saturation (SpO 2) was \\\u003C95%.\n8. Patients with HIV infection.\n9. Patients with active hepatitis B or hepatitis C infection.\n10. Patients with other commodities that the investigators considered not suitable for the enrollment.","65 Years",{"count":83,"type":20},60,[23],"The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.",[27,87],"High Risk Acute Myeloid Leukemia","2024-04-27",{"date":90,"type":33},"2024-05-01",{"date":92,"type":33},"2024-02-15",{"date":94,"type":20},"2026-12-30",{"name":39,"class":40}]