[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560078":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"targeted dosing ATG cohort","EXPERIMENTAL","The targeted dosing ATG cohort received the same dose of medication at -5 days and -4 days as the traditional administration method (-5days, 1.5mg\u002Fkg; -4days 2.5mg\u002Fkg), Two individual doses were given on -3days and day -2days according to the dose adjustment strategy.",[13],"Drug: individualized ATG dosing strategy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","individualized ATG dosing strategy","Investigators quantified active ATG exposure in 106 haploidentical peripheral blood stem cell transplantation (haplo-PBSCT) recipients, who received a conventional fixed dose of 10 mg\u002Fkg ATG during conditioning, the optimal concentration range of active ATG-AUC was determined through the application of machine learning methods, was found to be 100-148.5 × 10\\^3 UE·d\u002FL. This concentration range was associated with a reduction in CMV\u002FEBV reactivation, without an increase in acute GVHD or malignant disease relapse. Mathematical function was then exploited to determine the total targeted ATG dose on -3days to -2days based on concentrations of active ATG on -5daysto -4days. Based on this function, investigators established a dosing strategy that aimed to maintain the active ATG-AUC within the optimal range.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"diahong Liu, MD","First Medical Center of Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Sheng Chen, master","CONTACT","15101156205","csto301@163.com",[33],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Hematology, First Medical Center of Chinese PLA General Hospital","RECRUITING","Beijing","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":29,"phone":48,"phoneExt":20,"email":20},"jiang Cao","010-66937166",{"type":25,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Daihong Liu","Professor","100560078","phase-2-atg-individualized-dosing-model-in-urd-pbsct-100560078",false,"NCT06572462","ATG Individualized Dosing Model in URD-PBSCT.","Application of Thymoglobulin (ATG) Individualized Dosing Model in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Patients with malignant hematological tumors who have indications for allogeneic hematopoietic stem cell transplantation.\n2. HLA-matched unrelated donor\n3. Patient age ≥14 years old and ≤65 years old\n4. ALT and AST ≤ 2.5 times the upper limit of normal values, bilirubin ≤ 2 times the upper limit of normal values\n5. Creatinine ≤ high limit of normal value\n6. No uncontrollable infection or serious mental illness\n7. Physical strength score is 0-2 (ECOG)\n8. Sign the informed consent form\n\nExclusion Criteria:\n\n1. Unrelated donor who is not HLA matched\n2. No indication for allogeneic hematopoietic stem cell transplantation\n3. Patient age \\\u003C14 years old or \\>65 years old\n4. The donor or recipient are pregnant\n5. Suffering from mental illness or other conditions and being unable to proceed as planned","ALL","14 Years","65 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","Anti-thymocyte globulin (ATG) is widely used in allogeneic hematopoietic stem cell transplantation to prevent severe graft-versus-host disease (GVHD) and graft failure. However, overexposure to ATG may increase cytomegalovirus (CMV), Epstein-Barr virus (EBV) reactivation, non-relapse mortality, and disease recurrence. A targeted dosing strategy was established based on ATG concentration monitoring and conducted a phase 2 trial to evaluate the safety and efficacy of the dosing strategy in adult unmanipulated haplo-PBSCT, a encouraging result was attained. In this trial, The ATG-targeted dosing strategy was extended to adult unrelated donor allogeneic hematopoietic stem cell transplantation, ATG was administered for 4 days (-5 days to -2 days) during conditioning. The ATG doses on-3 days and- 2days were adjusted by our dosing strategy to achieve the optimal ATG exposure. The primary endpoint was CMV reactivation on +180 days.",[70,71,72],"Cytomegalovirus Infections","Infection Reactivation","Stem Cell Transplant Complications","2024-11-28",{"date":75,"type":76},"2024-12-03","ACTUAL",{"date":78,"type":76},"2020-12-31",{"date":80,"type":64},"2025-06-30",{"name":5,"class":6},1]