[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519645":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":68,"collaborators":70,"id":74,"slug":21,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":21,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":21,"enrollmentInfo":82,"targetDuration":21,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":21,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Northside Hospital, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Belumosudil Plus Rituximab","EXPERIMENTAL","Belumosudil plus Rituximab",[13,14],"Drug: Belumosudil","Drug: Rituximab",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Belumosudil","200mg PO QD x 24 cycles (28-day cycle)",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Rituximab","375mg\u002Fm2 IV Q1 week x 4 weeks, then Q3 months x4 doses",[9],[27],{"name":28,"affiliation":29,"role":30},"Scott Solomon, MD","BMTGA\u002FNorthside Hospital","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","404-255-1930","ssolomon@bmtga.com",{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},"Caitlin Guzowski, MBA, MHA","404-851-8523","caitlin.guzowski@northside.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Northside Hospital","RECRUITING","Atlanta","Georgia","30342","United States",{"type":49,"coordinates":50},"Point",[51,52],-84.38798,33.749,{"lat":52,"lon":51},[55,56,59,61,63,64,66],{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},{"name":57,"role":58,"phone":21,"phoneExt":21,"email":21},"H. Kent Holland, MD","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":21,"phoneExt":21,"email":21},"Asad Bashey, MD",{"name":62,"role":58,"phone":21,"phoneExt":21,"email":21},"Lawrence E Morris, MD",{"name":28,"role":30,"phone":21,"phoneExt":21,"email":21},{"name":65,"role":58,"phone":21,"phoneExt":21,"email":21},"Melhem Solh, MD",{"name":67,"role":58,"phone":21,"phoneExt":21,"email":21},"Lizamarie Bachier-Rodriguez, MD",{"type":69,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[71],{"name":72,"class":73},"Sanofi","INDUSTRY","100519645",false,"NCT06046248","Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease","Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease","Inclusion Criteria:\n\n* First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)\n* Previously untreated, defined by having received \\\u003C10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD\n* KPS \\>\u002F= 70%\n* Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC \\>750 cells\u002Fmm3; Platelets \\>30,000 cells\u002Fmm#\n\nExclusion Criteria:\n\n* Late persistent or recurrent aGVHD\n* Active uncontrolled infection\n* History of HIV infection\n* Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.\n* Calculated CrCl \\\u003C30mL\u002Fmin\n* AST and\u002For ALT \\>5x ULN or direct bilirubin \\>3x ULN\n* Cardiac ejection fraction \\\u003C40% or history of uncontrolled cardiac arrhythmias\n* Has received more than one allogeneic transplant prior to the occurrence of cGVHD","ALL","18 Years",{"count":83,"type":84},25,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.",[90],"Chronic Graft Versus Host Disease","2026-04-15",{"date":93,"type":94},"2026-04-20","ACTUAL",{"date":96,"type":94},"2024-01-29",{"date":98,"type":84},"2027-12-31",{"name":5,"class":6},1]