[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346652":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":46,"responsibleParty":68,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Decitabine plus mBU\u002FCY for HLA-mismatched HSCT","EXPERIMENTAL","Decitabine plus mBU\u002FCY as precondition regimen for High Risk Acute Leukemia With MRD at the time of HLA-mismatched HSCT.\n\nDetails:\n\nThe conditioning therapy for human eukocyte antigen (HLA)-mismatched HSCT patients was decitabine plus modified BU\u002FCY and ATG,consisting of decitabine 100mg·m-2·d-1 q12h on days-12 and -11,cytarabine (Ara-C 4 g·m-2·d-1) intravenously on days -10 to -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, simustine (Me-CCNU, 250 mg\u002Fm2), orally once on day -3, and ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2.",[13,14],"Drug: Decitabine","Drug: mBU\u002FCY and ATG",{"label":16,"type":10,"description":17,"interventionNames":18},"Decitabine plus mBU\u002FCY for matched sibling transplant","Decitabine plus mBU\u002FCY as precondition regimen for High Risk Acute Leukemia With MRD at the time of matched sibling transplant.\n\nDetails:\n\nIn matched sibling transplantations, patients received decitabine 100mg·m-2·d-1 q12h on days-12 and -11,hydroxycarbamide (80 mg\u002Fkg) orally on day -10 and a lower dose of Ara-C (2 g·m-2·d-1) on day -9, busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, cyclophosphamide (CY 1.8 g·m-2·d-1), intravenously on days -5 to -4, simustine (Me-CCNU, 250 mg\u002Fm2), orally once on day -3.",[13,19],"Drug: mBU\u002FCY",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Decitabine","Decitabine 200mg.m-2.d-1 intervanously on days -12 and -11",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"mBU\u002FCY and ATG","Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Simustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"mBU\u002FCY","hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Simustine (Me-CCNU, 250 mg·m-2) orally once on day -3",[16],[36],{"name":37,"affiliation":5,"role":38},"Xiao-Jun Huang","STUDY_CHAIR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","+86 010 88326666","yanchenhua@vip.sina.com",{"name":45,"role":41,"phone":42,"phoneExt":26,"email":43},"Chen-Hua Yan",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Peking University Institute of Hematology,Beijing","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62,65],{"name":63,"role":41,"phone":64,"phoneExt":26,"email":43},"Chen-hua Yan, MD","86 010 88326666",{"name":66,"role":67,"phone":26,"phoneExt":26,"email":26},"Xiao-Jun Huang, MD","PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Xiaojun Huang,MD","Director of the Hematology Department","100346652","phase-2-decitabine-plus-mbucy-for-high-risk-acute-leukemia-with-mrd-pre-hsct-100346652",false,"NCT03793517","Decitabine Plus mBU\u002FCY for High Risk Acute Leukemia With MRD Pre-HSCT","Decitabine Plus mBU\u002FCY for High Risk Acute Leukemia With Minimal Residual Disease Pre-HSCT","Inclusion Criteria:\n\n* acute leukemia patients with MLL-r,TLS-ERG,or SIL-TAL1,whose minimal residual disease were detectable pre-HSCT\n\nExclusion Criteria:\n\n* pregnancy women\n* uncontrolled severe infection","ALL","18 Years","55 Years",{"count":82,"type":83},55,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE2","PHASE3","Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with high-risk molecular biomarkers who still have detectable minimal residual disease(MRD) pre-HSCT were at very high risk of relapse, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastiv syndrome. It was reported that the combination of decitabine, with busufan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU\u002FCY) as a preparative regimen for allo-HSCT in patients with very high-risk AL and detectable MRD pre-HSCT.",[90,91,92],"Stem Cell Transplant Complications","Leukemia, Myeloid, Acute","Leukemia Relapse",[94,95,96,97,98],"high risk acute myeloid leukemia","hematopoietic stem cell transplantation","leukemia relapse","preparation regimen","decitabine","2020-03-09",{"date":101,"type":102},"2020-03-10","ACTUAL",{"date":104,"type":102},"2018-09-01",{"date":106,"type":83},"2026-10",{"name":5,"class":6},1]