[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582896":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":48,"collaborators":19,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":19,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"thiotepa 5 mg\u002Fkg\u002Fday ; busulfan 3.2 mg\u002Fkg\u002Fday ; fludarabine 30 mg\u002Fm²\u002Fday","EXPERIMENTAL","Eligible patients will receive the following conditioning regimen: thiotepa 5 mg\u002Fkg\u002Fday on Days -10 to -9; busulfan 3.2 mg\u002Fkg\u002Fday on Days -8 to -6; fludarabine 30 mg\u002Fm²\u002Fday on Days -6 to -2; and rabbit anti-thymocyte globulin (rATG) 1.5-2.5 mg\u002Fkg\u002Fday on Days -5 to -2. Hematopoietic stem cell infusion will be performed on Day 0. Graft-versus-host disease (GVHD) prophylaxis will include cyclosporine A (CsA), mycophenolate mofetil (MMF), and methotrexate (MTX).",[13],"Drug: Thiotepa ;busulfan;fludarabine",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DRUG","Thiotepa ;busulfan;fludarabine",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yu Wang MD","CONTACT","86-8832666","ywyw3172@sina.com",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41,45],{"name":42,"role":23,"phone":43,"phoneExt":19,"email":44},"Yu Wang","861088326001","ywyw3127@sina.com",{"name":46,"role":47,"phone":19,"phoneExt":19,"email":19},"xiaojun huang","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Xiao-Jun Huang","Prof.","100582896","phase-2-thiotepa-combined-with-busulfan-and-fludarabine-conditioning-regimen-for-haploidentical-hematopoietic-stem-cell-transplantation-in-elderly-patients-with-high-risk-acute-myeloid-leukemia-100582896",false,"NCT06869265","Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia","A Multicenter, Single-Arm, Prospective Clinical Study of Thiotepa Combined With Busulfan and Fludarabine Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplantation in Elderly Patients With High-Risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age 55-70 years (inclusive).\n2. Diagnosis of high-risk AML , include relapsed\u002Frefractory AML or CR MRD+ or ELN22 adverse risk group . Relapsed\u002Frefractory AML defined as at least one of the following: recurrence of leukemia cells in peripheral blood or bone marrow blasts \\>5% after complete remission (CR), failure to achieve remission after two courses of standard induction therapy, relapse within 12 months after consolidation therapy, relapse after 12 months that is refractory to conventional chemotherapy, multiple relapses, or persistent extramedullary leukemia .\n3. Scheduled to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).\n4. Adequate organ function.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Unwillingness or refusal to accept the study treatment protocol.\n2. Presence of donor-specific anti-HLA antibodies.\n3. Known human immunodeficiency virus (HIV) infection.\n4. Active hepatitis B or C, or chronic active hepatitis.\n5. Uncontrolled active infection at the time of enrollment.\n6. Any other condition deemed by the investigator as unsuitable for study inclusion.","ALL","55 Years","70 Years",{"count":62,"type":63},56,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","Abstract:\n\nThis clinical study is designed to evaluate the efficacy and safety of a thiotepa, busulfan, and fludarabine (TBF) conditioning regimen for haploidentical hematopoietic stem cell transplantation (haplo-HSCT) in elderly patients (≥55 years) with high-risk acute myeloid leukemia (AML). A total of 56 eligible patients will be enrolled in this prospective, single-arm, multicenter trial.\n\nStudy Design:\n\nThis is a multicenter, single-arm, prospective clinical trial. Eligible patients will receive the following conditioning regimen: thiotepa 5 mg\u002Fkg\u002Fday on Days -10 to -9; busulfan 3.2 mg\u002Fkg\u002Fday on Days -8 to -6; fludarabine 30 mg\u002Fm²\u002Fday on Days -6 to -2; and rabbit anti-thymocyte globulin (rATG) 1.5-2.5 mg\u002Fkg\u002Fday on Days -5 to -2. Hematopoietic stem cell infusion will be performed on Day 0. Graft-versus-host disease (GVHD) prophylaxis will include cyclosporine A (CsA), mycophenolate mofetil (MMF), and methotrexate (MTX). The primary endpoint of this study is 1-year relapse-free survival (RFS).\n\nInclusion Criteria:\n\nAge 55-70 years (inclusive). Diagnosis of high-risk AML , include relapsed\u002Frefractory AML or CR MRD+ or ELN22 adverse risk group .Relapsed\u002Frefractory AML defined as at least one of the following: recurrence of leukemia cells in peripheral blood or bone marrow blasts \\>5% after complete remission (CR), failure to achieve remission after two courses of standard induction therapy, relapse within 12 months after consolidation therapy, relapse after 12 months that is refractory to conventional chemotherapy, multiple relapses, or persistent extramedullary leukemia）.\n\nScheduled to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).\n\nAdequate organ function. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Written informed consent obtained.\n\nExclusion Criteria:\n\nUnwillingness or refusal to accept the study treatment protocol. Presence of donor-specific anti-HLA antibodies. Known human immunodeficiency virus (HIV) infection. Active hepatitis B or C, or chronic active hepatitis. Uncontrolled active infection at the time of enrollment. Any other condition deemed by the investigator as unsuitable for study inclusion.",[69,70,71],"Acute Myeloid Leukemia (AML)","High Risk Acute Myeloid Leukemia(AML)","Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)","2025-05-15",{"date":74,"type":75},"2025-05-18","ACTUAL",{"date":77,"type":75},"2025-05-01",{"date":79,"type":63},"2029-04-01",{"name":5,"class":6},1]