[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490665":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":56,"centralContacts":60,"locations":65,"responsibleParty":67,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":65,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":65,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":65,"overallStatus":88,"whyStopped":65,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":65},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","decitabine (Chia Tai Tianqing Pharma) 15 mg\u002Fm2 daily intravenously for consecutive 3 days (day 1 to day 3), combined with umbilical cord blood infusion (day 8)",[13,14,15,16,17],"Drug: decitabine","Biological: umbilical cord blood","Drug: Granulocyte-colony stimulating factor","Drug: Recombinant human thrombopoietin \u002F thrombopoietin receptor agonist","Drug: Recombinant human erythropoietin",{"label":19,"type":20,"description":21,"interventionNames":22},"Arm B","ACTIVE_COMPARATOR","Supportive therapy: G-CSF for patients with absolute neutrophil count ≤ 1.5 × 109\u002FL, rhTPO\u002FTPO-R with platelet count ≤ 30 × 109\u002FL, EPO with hemoglobin ≤ 85g\u002FL.",[15,16,17],[24,31,38,44,50],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","decitabine","15 mg\u002Fm2 daily intravenously for consecutive 3 days",[9],[30],"Dec",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","umbilical cord blood","MNC ≥ 3\\*108 cells; HLA compatibility ≥ 5\u002F6",[9],[37],"UCB",{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Granulocyte-colony stimulating factor","Granulocyte-colony stimulating factor will be used when absolute neutrophil count ≤ 1.5 × 109\u002FL",[9,19],[43],"G-CSF",{"type":25,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Recombinant human thrombopoietin \u002F thrombopoietin receptor agonist","Recombinant human thrombopoietin or thrombopoietin receptor agonist will be used when platelet count ≤ 30 × 109\u002FL",[9,19],[49],"rhTPO\u002FTPO-RA",{"type":25,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Recombinant human erythropoietin","Recombinant human erythropoietin will be used when hemoglobin ≤ 85 g\u002FL",[9,19],[55],"EPO",[57],{"name":58,"affiliation":5,"role":59},"Yue Han","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"Yaqiong Tang","CONTACT","18896588075",null,"tangyaqiong@suda.edu.cn",{"type":68,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100490665","phase-3-decitabine-and-umbilical-cord-blood-for-poor-graft-function-post-allo-hsct-100490665",false,"NCT05669079","Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allo-HSCT","Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109\u002FL, platelet count ≤ 30 × 109\u002FL, hemoglobin ≤ 85g\u002FL, lasting for more than 2 consecutive weeks;\n2. Full donor chimerism;\n3. Primary disease in remission;\n4. No severe GVHD and relapse.\n\nExclusion Criteria:\n\n1. Allergic to decitabine or any components of frozen preservation of umbilical cord blood;\n2. Active infections;\n3. Uncontrolled GVHD;\n4. Severe organ dysfunction;\n5. Relapse of underlying malignancies;\n6. Graft failure;\n7. Received decitabine or participated in other clinical trials within one month before screening.","ALL","16 Years","65 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","This randomized trial aimed at validating the efficacy and safety of low-dose decitabine, together with umbilical cord blood in PGF post allo-HSCT patients.",[87],"Poor Graft Function","NOT_YET_RECRUITING","2023-06-08",{"date":91,"type":92},"2023-06-09","ACTUAL",{"date":94,"type":81},"2023-08-01",{"date":96,"type":81},"2026-11-01",{"name":5,"class":6}]