[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619138":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":18,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Ruxolitinib Arm","EXPERIMENTAL","Ruxolitinib combined with Corticosteroids",[13,14],"Drug: Ruxolitinib","Drug: Corticosteroids",{"label":16,"type":17,"description":18,"interventionNames":19},"Comparator arm","ACTIVE_COMPARATOR",null,[14],[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":18},"DRUG","Ruxolitinib","Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 0.5mg\u002Fkg\u002Fd , iv or iv gtt for at least 5 days, then taper according to the clinical response.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":18},"Corticosteroids","Methylprednisolone: 2mg\u002Fkg\u002Fd , iv or iv gtt for at least 1 week, then taper according to the clinical response.",[16,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Liping Dou, M.D., Ph.D.","CONTACT","010-66937079","lipingruirui@163.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":18},"Department of Hematology, Senior Department of Hematology, The Fifth Medical Center of PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Daihong Liu","100619138","phase-2-novel-first-line-therapies-for-grade-ii-acute-gvhdgraft-versus-host-disease--100619138",false,"NCT07340723","Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )","Novel First-line Therapies for Grade II Acute GVHD: a Randomized Controlled Trial","GVHD","Inclusion Criteria:\n\n1. Diagnosed with hematological diseases.\n2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.\n3. New onset of grade II acute GVHD or intermediate or high risk aGVHD (based on modified GVHD Glucksberg criteria) within 100 days post-transplantation.\n\nExclusion Criteria:\n\n1. Recipients of second allogeneic stem cell transplant.\n2. Acute GVHD induced by donor lymphocyte infusion, interferon.\n3. Received first line aGVHD treatment before enrollment.\n4. Overlap GVHD syndrome.\n5. Pregnant or breast-feeding women.\n6. Pregnant or breast-feeding women.\n7. Serum creatinine \\> 2.0 mg\u002FdL or creatinine clearance \\\u003C 40 mL\u002Fmin measured or calculated by Cockroft-Gault equation.\n8. Uncontrolled infection.\n9. Human immunodeficiency virus infection.\n10. Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.\n11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.\n12. Allergic history to Janus kinase inhibitors.\n13. Severe organ dysfunction unrelated to underlying GVHD, including:\n\n(1)Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).\n\n(2)Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.\n\n(3)Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.\n\n14.Received Janus kinase inhibitor therapy after allo-HSCT for any indication. 15.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.","ALL","14 Years",{"count":65,"type":66},168,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for grade II acute GVHD (graft-versus-host disease )",[72,73],"GVHD,Acute","Stem Cell Transplant Complications",[75,23,76],"acute graft-versus-host disease","first line therapy","2026-01-05",{"date":79,"type":80},"2026-01-14","ACTUAL",{"date":82,"type":80},"2025-06-01",{"date":84,"type":66},"2027-06-01",{"name":53,"class":6},1]