[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607153":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":60,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ruxolitinib Monotherapy","ACTIVE_COMPARATOR","Participants will receive ruxolitinib (10 mg orally twice daily, approximately every 12 hours, with or without food). Treatment will continue for up to 24 weeks. Dose reductions or discontinuation may occur according to protocol-defined safety and response criteria. Corticosteroid tapering will follow study guidelines.",[13],"Drug: Ruxolitinib (JAKAVI®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Ruxolitinib Plus Etanercept","EXPERIMENTAL","Participants will receive ruxolitinib (10 mg orally twice daily, approximately every 12 hours, with or without food) combined with etanercept (25 mg subcutaneous injection, twice weekly for 4 weeks, total 8 doses). Etanercept may be extended for an additional 2-4 weeks at investigator's discretion for patients with partial response. Treatment with ruxolitinib may continue for up to 24 weeks, with dose tapering per study protocol. Corticosteroid tapering will follow study guidelines.",[13,19],"Drug: Etanercept (Enbrel)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ruxolitinib (JAKAVI®)","Ruxolitinib will be administered orally at a dose of 10 mg twice daily (approximately every 12 hours), with or without food. Dose modifications are allowed according to protocol-defined safety and efficacy criteria. Ruxolitinib may be continued for up to 24 weeks, with tapering guided by patient response and GVHD status.",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Etanercept (Enbrel)","Etanercept will be administered as a subcutaneous injection at a dose of 25 mg twice weekly for 4 weeks (total 8 doses). For patients with partial response at day 28, treatment may be extended once weekly for an additional 2-4 weeks at the investigator's discretion.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Hengwei Wu, MD","CONTACT","0571 8723 6562","wuhengwei@zju.edu.cn",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The First Affiliated Hospital of Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":47,"coordinates":48},"Point",[49,50],120.16142,30.29365,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":36},"Hengwei Wu","0571 87236562",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Yanmin Zhao","Vice Director, Bone Marrow Transplantation Center",[61,63,65,67,69],{"name":62,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":64,"class":6},"Tongji Hospital",{"name":66,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":68,"class":6},"The Children's Hospital of Zhejiang University School of Medicine",{"name":70,"class":6},"Ruijin Hospital","100607153","ruxolitinib-plus-etanercept-vs-ruxolitinib-for-steroid-refractory-severe-acute-gvhd-100607153",false,"NCT07184853","Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD","Prospective Multicenter Randomized Study of Ruxolitinib Plus Etanercept vs Ruxolitinib Alone for Corticosteroid-Refractory Severe Acute GVHD After Allogeneic HSCT","RESCUE","Inclusion Criteria:\n\nReceived allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source (matched sibling, matched unrelated, or haploidentical), using bone marrow, peripheral blood stem cells, or cord blood; conditioning regimen may be myeloablative, reduced-intensity, or non-myeloablative.\n\nAge between 12 and 70 years.\n\nEastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n\nClinical diagnosis of grade III-IV acute graft-versus-host disease (aGVHD) according to MAGIC criteria.\n\nEvidence of neutrophil and platelet engraftment prior to study treatment (absolute neutrophil count \\>1,000\u002Fmm³ and platelet count ≥20,000\u002Fmm³ within 48 hours before study entry; growth factor support and transfusion permitted).\n\nDiagnosis of steroid-refractory aGVHD, defined as one of the following:\n\nDisease progression after 3-5 days of methylprednisolone 2 mg\u002Fkg\u002Fday (or equivalent).\n\nNo improvement after 7 days of methylprednisolone 2 mg\u002Fkg\u002Fday (or equivalent).\n\nProgression from grade II to grade III-IV aGVHD after 3-5 days of methylprednisolone 1 mg\u002Fkg\u002Fday (or equivalent).\n\nAble to take oral medication.\n\nExpected survival \\>8 weeks.\n\nWomen of childbearing potential must have a negative serum β-HCG test prior to enrollment; both male and female participants of reproductive potential must agree to use effective contraception during the study and for 3 months after study completion.\n\nVoluntary written informed consent provided and ability to comply with study procedures.\n\nExclusion Criteria:\n\nPrior systemic treatment for aGVHD other than corticosteroids with or without calcineurin inhibitors (CNI); prophylactic use of MTX, MMF, or CD25 monoclonal antibody is permitted.\n\nClinical features consistent with de novo chronic GVHD or overlap syndrome (per Jagasia 2015).\n\nUncontrolled active infection, including severe bacterial, fungal, viral, or parasitic infection. Patients on appropriate treatment without evidence of progression may be eligible.\n\nEvidence of active tuberculosis.\n\nKnown HIV infection.\n\nRelapse of primary malignancy or post-transplant lymphoproliferative disorder.\n\nSevere respiratory disease, including mechanical ventilation or resting oxygen saturation \\\u003C90%.\n\nRenal dysfunction: serum creatinine \\>2.0 mg\u002FdL, requirement for dialysis, or creatinine clearance \\\u003C30 mL\u002Fmin (Cockcroft-Gault).\n\nActive hepatitis B infection (HBsAg positive with HBV DNA ≥1×10³ IU\u002FmL) or active hepatitis C infection (HCV antibody positive with detectable HCV RNA above normal).\n\nClinically significant or uncontrolled cardiac disease, including recent myocardial infarction, uncontrolled hypertension, NYHA class III\u002FIV heart failure, unstable angina, or clinically significant arrhythmia (e.g., sustained ventricular tachycardia, second- or third-degree AV block).\n\nCholestatic disease or unresolved hepatic veno-occlusive disease not attributed to aGVHD.\n\nHistory of progressive multifocal leukoencephalopathy (PML).\n\nPrior exposure to JAK inhibitors after allo-HSCT.\n\nParticipation in another investigational drug trial within 30 days or within 5 half-lives of the investigational drug (whichever is longer).\n\nPrior history of grade ≥3 non-hematologic adverse events attributable to ruxolitinib or etanercept.\n\nAny condition judged by the investigator to place the patient at undue risk or interfere with study participation.\n\nKnown hypersensitivity or intolerance to systemic immunosuppressive agents.\n\nPregnant or breastfeeding women.","ALL","12 Years","70 Years",{"count":83,"type":84},122,"ESTIMATED","INTERVENTIONAL",[87],"NA","This is a prospective, multicenter, randomized controlled trial designed to evaluate whether the combination of ruxolitinib and etanercept provides superior efficacy compared with ruxolitinib monotherapy in patients with severe corticosteroid-refractory acute graft-versus-host disease (SR-aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\nAcute graft-versus-host disease (aGVHD) is one of the most common and life-threatening complications following allo-HSCT. Although corticosteroids remain the standard first-line treatment, many patients do not respond adequately. For patients with severe steroid-refractory aGVHD, the prognosis is extremely poor, with high short-term mortality and very low long-term survival.\n\nRuxolitinib, a JAK1\u002F2 inhibitor, has been approved for the treatment of SR-aGVHD, but response rates remain suboptimal, particularly in patients with gastrointestinal involvement. Etanercept, a tumor necrosis factor-alpha (TNF-α) inhibitor, has shown activity in GVHD by targeting inflammatory pathways. Previous observational studies from our center suggested that combining ruxolitinib with etanercept may improve response rates, especially in gastrointestinal and hepatic GVHD, without significantly increasing relapse risk.\n\nIn this trial, approximately 122 patients with grade III-IV SR-aGVHD will be randomized 1:1 to receive either ruxolitinib alone or ruxolitinib plus etanercept. The primary endpoint is the overall response rate (ORR) at day 28. Secondary endpoints include durable response, best overall response, failure-free survival, overall survival, cumulative incidence of relapse, non-relapse mortality, incidence of chronic GVHD, and safety outcomes.\n\nThis study seeks to provide new clinical evidence for an optimized treatment strategy for patients with severe SR-aGVHD, aiming to improve outcomes in this high-risk population.",[90],"Graft vs Host Disease",[92,93,94,95,96,97,98,99,100],"Ruxolitinib","Etanercept","JAK1\u002F2 inhibitor","TNF-α inhibitor","Corticosteroid-refractory GVHD","Severe aGVHD","Allo-HSCT complications","Graft-versus-Host Disease treatment","Immunosuppression","2025-09-19",{"date":103,"type":104},"2025-09-22","ACTUAL",{"date":106,"type":84},"2025-09-25",{"date":108,"type":84},"2028-09-25",{"name":5,"class":6},1]