[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611733":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":24,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":24,"maxAge":24,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":24,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Emapalumab 3 mg\u002Fkg","ACTIVE_COMPARATOR","Patients randomized to this arm will receive 3mg\u002Fkg of emapalumab intravenously (IV) once on day +1 after HSCT. Up to two additional, 10mg\u002Fkg rescue doses may be administered if patients developed signs and symptoms of acute graft rejection. Rescue dose administration decisions will be made in consultation with the lead study investigator. Emapalumab is a ligand-based therapy, which means high levels of circulating ligand (i.e. interferon gamma) will rapidly consume the drug. For these reasons, rescue doses may be given as early as 24 hours from the prior dose.",[13],"Drug: Emapalumab 3 mg\u002Fkg",{"label":15,"type":10,"description":16,"interventionNames":17},"Emapalumab 10 mg\u002Fkg","Patients randomized to this arm will receive 10mg\u002Fkg of emapalumab intravenously (IV) once on day +1 after HSCT. Up to two additional, 10mg\u002Fkg rescue doses may be administered if patients developed signs and symptoms of acute graft rejection. Rescue dose administration decisions will be made in consultation with the lead study investigator. Emapalumab is a ligand-based therapy, which means high levels of circulating ligand (i.e. interferon gamma) will rapidly consume the drug. For these reasons, rescue doses may be given as early as 24 hours from the prior dose.",[18],"Drug: Emapalumab 10 mg\u002Fkg",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Subjects will be randomized to either receive a 3mg\u002Fkg or 10mg\u002Fkg intravenous dose of emapalumab once and may receive up to two additional doses if clinical concern for impending graft rejection develops.",[9],null,{"type":21,"name":15,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":5,"role":30},"Anthony Sabulski, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":24,"email":36},"Jessica Anderson, BSN, RN, CCRC","CONTACT","513-636-4200","Jessica.Anderson@cchmc.org",{"name":38,"role":34,"phone":35,"phoneExt":24,"email":39},"Manisha Pathak, MS","Manisha.Pathak@cchmc.org",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.51439,39.12711,{"lat":53,"lon":52},[56,57,58],{"name":33,"role":34,"phone":35,"phoneExt":24,"email":36},{"name":38,"role":34,"phone":35,"phoneExt":24,"email":39},{"name":29,"role":30,"phone":24,"phoneExt":24,"email":24},{"type":60,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[62],{"name":63,"class":64},"Sobi, Inc.","INDUSTRY","100611733","early-phase-1-prevention-of-graft-rejection-in-hematopoietic-stem-cell-transplant-hsct-recipients-100611733",false,"NCT07244419","Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients","Emapalumab for the Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients","Inclusion Criteria:\n\n* All patients undergoing allogeneic HSCT at our institution will be evaluated for graft rejection risk factors. Patients deemed high risk for graft rejection will have 2 or more of the following: mismatched or haploidentical donor, ex vivo t-cell depleted graft, prior history of graft rejection.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any constituent of the study medication.","ALL",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","The investigators hypothesize that graft rejection after hematopoietic stem cell transplant (HSCT) is primarily driven by interferon gamma, and prophylactic interferon gamma inhibition in high-risk patients will prevent graft rejection. Additionally, knowledge of emapalumab PK\u002FPD and in vitro mechanistic effects of emapalumab in this novel setting will guide optimization of dosing regimens and treatment approaches in future studies.",[81,82],"Hematopoietic Stem Cell Transplantation","Graft Failure","2026-01-21",{"date":85,"type":86},"2026-01-22","ACTUAL",{"date":88,"type":86},"2026-01-07",{"date":90,"type":75},"2029-08",{"name":5,"class":6},1]