[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655968":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":46,"overallOfficials":34,"centralContacts":52,"locations":34,"responsibleParty":58,"collaborators":34,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":34,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":34,"enrollmentInfo":71,"targetDuration":34,"studyType":74,"phases":34,"briefSummary":75,"conditions":76,"keywords":34,"overallStatus":79,"whyStopped":34,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":34},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"1-year transplant-related mortality (TRM)","The proportion of participants who die from transplant-related causes, including regimen-related toxicity, infection, and graft-versus-host disease, as defined in the study protocol.","From Day 0 through 1 year after transplantation",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"Neutrophil Engraftment","Time to neutrophil engraftment, defined as the first of 3 consecutive days with an absolute neutrophil count ≥0.5 × 10\\^9\u002FL；","From Day 0 through Day 28",{"measure":19,"description":20,"timeFrame":21},"Platelet Engraftment","Time to platelet engraftment, defined as the first of 7 consecutive days with platelet count ≥20 × 10\\^9\u002FL without platelet transfusion.","From Day 0 through Day 100",{"measure":23,"description":24,"timeFrame":21},"Primary Graft Failure","Proportion of participants without neutrophil engraftment or with graft failure, according to the study protocol.",{"measure":26,"description":27,"timeFrame":12},"Overall Survival","Proportion of participants alive, irrespective of cause of death.",{"measure":29,"description":30,"timeFrame":21},"Grade II-IV Acute graft-versus-host disease（ GVHD）","Incidence of grade II-IV acute graft-versus-host disease.",{"measure":32,"description":33,"timeFrame":12},"Moderate or Severe Chronic graft-versus-host disease（GVHD）","Incidence of moderate or severe chronic graft-versus-host disease.",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"COHORT","PROSPECTIVE","Severe aplastic anemia is a bone marrow failure disorder characterized by reduced blood cell production. For participants who need transplantation and do not have a fully matched sibling donor, haploidentical hematopoietic stem cell transplantation is an important treatment option. Older participants may have reduced organ function, a higher risk of infection, and lower tolerance of intensive treatment.\n\nThiotepa-based conditioning regimens are used in routine clinical practice before transplantation. In this study, the treating clinical team independently determines the conditioning regimen, medication doses and schedules, prevention of graft-versus-host disease, and supportive care according to each participant's clinical condition. Study participation does not assign, require, or change any treatment.\n\nThis is a prospective, single-center observational cohort study. The study will consecutively include participants aged 50 years or older with severe or very severe aplastic anemia who receive haploidentical hematopoietic stem cell transplantation with thiotepa-based conditioning at Peking University People's Hospital. Routine clinical information, transplantation information, and routinely collected follow-up information will be recorded through 1 year after transplantation.\n\nThe primary outcome is transplant-related mortality within 1 year after transplantation. Secondary outcomes include overall survival, hematopoietic engraftment, graft failure, acute and chronic graft-versus-host disease, cytomegalovirus and Epstein-Barr virus reactivation, serious infections, and serious adverse events. The study will not add treatment, examinations, blood collection, or follow-up visits beyond routine care.","The study population will consist of consecutively identified participants aged 50 years or older with severe or very severe aplastic anemia who are scheduled to undergo haploidentical hematopoietic stem cell transplantation at Peking University People's Hospital. The treating clinical team will independently select a thiotepa-based conditioning regimen as part of routine clinical care. The study will prospectively observe participants with available baseline, transplantation, and routine follow-up information for 1 year after transplantation. Up to 10 participants are planned for enrollment.",[41],{"label":42,"type":34,"description":43,"interventionNames":44},"Thiotepa-Based Conditioning Cohort","Participants aged 50 years or older with severe aplastic anemia or very severe aplastic anemia who receive haploidentical hematopoietic stem cell transplantation with a thiotepa-based conditioning regimen. The conditioning regimen is selected by the treating clinical team before study enrollment. The study does not assign or alter treatment.",[45],"Drug: Thiotepa",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":34},"DRUG","Thiotepa","The exposure of interest is a conditioning regimen containing thiotepa. Thiotepa and all accompanying treatment are selected by treating clinicians as part of routine care, independently of study participation. The study does not mandate drug dose, schedule, graft-versus-host disease prophylaxis, or supportive care.",[42],[53],{"name":54,"role":55,"phone":56,"phoneExt":34,"email":57},"Xu zheng li","CONTACT","88324002","xuzhengli0202@163.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Xiao-Jun Huang","Professor","100655968","thiotepa-based-conditioning-for-haploidentical-hsct-in-older-patients-with-severe-aplastic-anemia-100655968",false,"NCT07819812","Thiotepa-Based Conditioning for Haploidentical Hematopoietic Stem Cell Transplantation in Older Patients With Severe Aplastic Anemia","A Prospective, Single-Center, Observational Cohort Study of Thiotepa-Based Conditioning in Older Participants With Severe or Very Severe Aplastic Anemia Undergoing Haploidentical Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age 50 years or older at transplantation.\n* Diagnosis of severe aplastic anemia or very severe aplastic anemia.\n* Planned to undergo haploidentical hematopoietic stem cell transplantation at Peking University People's Hospital.\n* The treating clinical team has independently selected a thiotepa-based conditioning regimen as part of routine clinical care before study enrollment.\n* Required baseline and transplantation information is available in the medical record.\n\nExclusion Criteria:\n\n* Diagnosis or transplantation type does not meet the study eligibility criteria.\n* The conditioning regimen does not include thiotepa.\n* Essential baseline information is unavailable, such that study eligibility cannot be determined.\n* For a participant with more than one transplantation episode, only the first episode meeting all eligibility criteria will be included in the analysis.","ALL","50 Years",{"count":72,"type":73},20,"ESTIMATED","OBSERVATIONAL","This prospective, single-center observational cohort study will follow participants aged 50 years or older with severe or very severe aplastic anemia who receive haploidentical hematopoietic stem cell transplantation with a thiotepa-based conditioning regimen as part of routine clinical care. Treatment decisions, including conditioning, prevention of graft-versus-host disease, and supportive care, are made by the clinical care team and are not assigned or changed by this study. The study will collect routine clinical and follow-up information for 1 year after transplantation to describe transplant-related mortality, survival, engraftment, graft failure, graft-versus-host disease, infections, and serious adverse events.",[77,78],"Severe Aplastic Anemia","Hematopoietic Cell Transplant","NOT_YET_RECRUITING","2026-09-16",{"date":82,"type":83},"2026-09-21","ACTUAL",{"date":85,"type":73},"2026-09-20",{"date":87,"type":73},"2028-12-31",{"name":5,"class":6}]