[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654333":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":43,"overallOfficials":11,"centralContacts":61,"locations":11,"responsibleParty":67,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":97,"whyStopped":11,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":11},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Grade 2-4 aGVHD within 100 days post transplantation",null,"Participants will be followed for an expected average of 100 days post transplantation",[14,17,19,21,23,25],{"measure":15,"description":11,"timeFrame":16},"Incidence of chronic GVHD (cGVHD) within 1 year post transplantation","Participants will be followed for an expected average of 1 year",{"measure":18,"description":11,"timeFrame":16},"Incidence of thrombotic microangiopathy within 1 year post transplantation",{"measure":20,"description":11,"timeFrame":16},"Cumulative incidence of relapse",{"measure":22,"description":11,"timeFrame":16},"Transplant-related mortality",{"measure":24,"description":11,"timeFrame":16},"Overall survival",{"measure":26,"description":11,"timeFrame":16},"Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV)",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"NA","SINGLE_GROUP","PREVENTION",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Sirolimus+Ruxolitinib+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG)","EXPERIMENTAL","Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Ruxolitinib+MMF+ATG (SRMA) for prophylaxis of aGVHD",[39,40,41,42],"Drug: Sirolimus","Drug: Ruxolitinib","Drug: MMF","Drug: ATG",[44,49,53,57],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"DRUG","Sirolimus","Sirolimus 2mg once daily, maintaining the concentration at 5-10 ng\u002Fml. Gradually reduce the dosage after +100 days. If the patient has stable engraftment and no GVHD, discontinue on +180 days.",[35],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"Ruxolitinib","Ruxolitinib is administered at a dose of 5mg twice daily from the start of the study until +90 days. The dose is reduced to 5mg once daily on +90 days, and discontinued on +120 days.",[35],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"MMF","MMF 0.5g, taken twice daily, is discontinued after 60 days. If it is resumed after 60 days, it should be taken for 2 weeks.",[35],{"type":45,"name":58,"description":59,"armGroupLabels":60,"otherNames":11},"ATG","2.5 mg\u002Fkg, from -5d to -2d",[35],[62],{"name":63,"role":64,"phone":65,"phoneExt":11,"email":66},"Yuqian Sun","CONTACT","+86-10-88324577","sunyuqian83@hotmail.com",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Xiao-Jun Huang","Chief of the Department of Hematology","100654333","phase-1-sirolimusruxolitinibmycophenolate-mofetil-for-prophylaxis-of-agvhd-in-patients-receiving-haplo-hsct-who-are-intolerant-to-cni-100654333",false,"NCT07796620","Sirolimus+Ruxolitinib+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to CNI","Sirolimus+Ruxolitinib+Mycophenolate Mofetil Regimen for Prophylaxis of Acute Graft-versus-host Disease (aGvHD) in Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation (Haplo-HSCT) Who Are Intolerant to Calcineurin Inhibitor","Inclusion Criteria:\n\n* Primary disease: hematological malignancies (including acute leukemia, myelodysplastic syndromes), nonmalignant disorders (including severe aplastic anaemia)\n* Renal injury or inability to tolerate the side effects of CNI: such as CNI renal toxicity (creatinine levels above the upper limit of normal), uncontrolled hypertension, and neurotoxicity rrom the time of hematopoietic stem cell infusion until +90 days after transplantation\n* Receiving haplo-HSCT for the first time\n\nExclusion Criteria:\n\n* Allergy or intolerance to study drugs\n* Active infection\n* Active GVHD\n* Transplantation-associated thrombotic microangiopathy\n* Key organ dysfunction: liver injury (total bilirubin more than 2 upper limit of normal) or heart injury (symptomatic heart failure or ejection fraction\\\u003C50%)\n* Eastern Cooperative Oncology Group (ECOG) score \\>2\n* Expected survival time \\\u003C30 days\n* Patients could not cooperate","ALL","14 Years",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Ruxolitinib and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.",[89,90,91],"Acute Leukemia","Myelodysplastic Syndromes","Severe Aplastic Anemia (SAA)",[50,46,93,94,95,96],"Mycophenolate Mofetil","Graft-versus-host-disease","Haploidentical","Calcineurin Inhibitor","NOT_YET_RECRUITING","2026-09-08",{"date":100,"type":101},"2026-09-09","ACTUAL",{"date":103,"type":82},"2026-10-01",{"date":105,"type":82},"2028-09-30",{"name":5,"class":6}]