[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560078":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":20,"id":51,"slug":20,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"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,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Department of Hematology, First Medical Center of Chinese PLA General Hospital","RECRUITING","Beijing","China",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":46,"role":29,"phone":47,"phoneExt":20,"email":20},"jiang Cao","010-66937166",{"type":25,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Daihong Liu","Professor","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":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"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.",[68,69,70],"Cytomegalovirus Infections","Infection Reactivation","Stem Cell Transplant Complications","2024-11-28",{"date":73,"type":74},"2024-12-03","ACTUAL",{"date":76,"type":74},"2020-12-31",{"date":78,"type":62},"2025-06-30",{"name":5,"class":6},1]