[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599939":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":20,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":20,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Patients with relapsed\u002Frefractory acute myeloid leukaemia eligible for enrolment should be bridged with venetoclax, azacitidine, in combination with homoharringtonine before allo-HCT.",[13],"Drug: VAH",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","VAH","For R\u002FR AML patients, VAH bridging to conditioning regimen for allo-HCT.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Xiaoxia HU","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","02164370045","hu_xiaoxia@126.com",[31],{"facility":32,"status":20,"city":33,"state":34,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":20},"Ruijin Hospital, Shanghai Jiaotong University School of Medicine","Shanghai","Shanghai Municipality","China","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100599939","phase-2-efficacy-and-safety-of-vah-as-a-bridging-regimen-to-allo-hct-in-relapsedrefractory-aml-100599939",false,"NCT07091006","Efficacy and Safety of VAH as a Bridging Regimen to Allo-HCT in Relapsed\u002FRefractory AML","A Prospective Study on the Efficacy and Safety of Venetoclax, Azacitidine, and Homoharringtonine (VAH) Combination as a Bridging Regimen to Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Aged 14 to 70 years (inclusive), regardless of gender;\n* The diagnosis of AML was confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests;\n* Relapsed AML: After achieving complete remission (CR), the reappearance of leukemic cells in peripheral blood, or ≥5% blasts in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration by leukemic cells.\n\nRefractory AML: Newly diagnosed cases that are unresponsive after two courses of standard induction therapy; patients who relapse within 12 months after consolidation\u002Fintensification therapy post-CR; patients who relapse after 12 months but fail to respond to conventional chemotherapy; patients with two or more relapses; or those with persistent extramedullary leukemia.\n\n* With RUNX1::RUNX1T1 AML: Positive measurable residual disease (MRD) on bone marrow flow evaluation after the second consolidation therapy and\u002For less than a 3-log decrease in the RUNX1::RUNX1T1 fusion gene and diagnostic baseline values;\n* ECOG score ≤2; HCT-CI score \\\u003C3; Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN); Alanine aminotransferase (ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN;\n* Left ventricular ejection fraction (LVEF) ≥50%;\n\nExclusion Criteria:\n\n* Allergies or contraindications to any of the drugs in the protocol;\n* Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;\n* Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);\n* Active autoimmune diseases such as SLE, rheumatoid arthritis, etc;\n* Patients with neurological or psychiatric disorders;\n* The patient is pregnant or breastfeeding;\n* Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.\n* Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study;","ALL","14 Years","70 Years",{"count":56,"type":57},44,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed\u002Frefractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed\u002Frefractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed\u002Frefractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed\u002Frefractory AML.",[63],"Relapse Leukemia","NOT_YET_RECRUITING","2025-07-28",{"date":67,"type":68},"2025-07-29","ACTUAL",{"date":70,"type":57},"2025-08-01",{"date":72,"type":57},"2028-05-01",{"name":5,"class":6},1]