[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100126972":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":53,"locations":63,"responsibleParty":368,"collaborators":370,"id":373,"slug":374,"hasResults":375,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":35,"eligibilityCriteria":379,"healthyVolunteers":375,"sex":380,"minAge":35,"maxAge":381,"enrollmentInfo":382,"targetDuration":35,"studyType":385,"phases":386,"briefSummary":389,"conditions":390,"keywords":395,"overallStatus":66,"whyStopped":35,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Stratum 1","EXPERIMENTAL","Recipients with non-malignant disorders, excluding thalassemia. Related or unrelated 8\u002F8 HLA-matched bone marrow",[13,14],"Drug: Treatment Plan 1: Stratum 1","Drug: GVHD Regimen B: BM Recipients",{"label":16,"type":10,"description":17,"interventionNames":18},"Stratum 2","Recipient with transfusion dependent thalassemia. Related or unrelated. 8\u002F8 HLA-matched bone marrow or 5-8\u002F8 HLA-matched UCB",[19,20,14],"Drug: Treatment Plan 2: Strata 2, 3, or 4","Drug: GVHD Regimen A: UCB Recipients",{"label":22,"type":10,"description":23,"interventionNames":24},"Stratum 3","Recipient with hemoglobinopathy Related or unrelated. 7\u002F8 HLA-matched bone marrow or 5-8\u002F8 HLA-matched UCB",[19,20,14],{"label":26,"type":10,"description":27,"interventionNames":28},"Stratum 4","Recipient with non-malignant disorder, excluding hemoglobinopathy Related or unrelated. 7\u002F8 HLA-matched bone marrow or 5-8\u002F8 HLA-matched UCB",[19,20,14],[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Treatment Plan 1: Stratum 1","Day -50 to -21: Hydroxyurea 30mg\u002Fkg PO q day Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg\u002Fm2 IV... Day -7: Fludarabine 30mg\u002Fm2 IV... Day -6: Fludarabine 30mg\u002Fm2 IV... Day -5: Fludarabine 30mg\u002Fm2 IV... Day -4: Fludarabine 30mg\u002Fm2 IV... Day -3: Melphalan 140 mg\u002Fm2 IV... (dose modifications for patients \\\u003C10 kgs) Procedure\u002FSurgery: Hematopoietic stem cell infusion on Day 0...",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Treatment Plan 2: Strata 2, 3, or 4","Day -50 to -21: Hydroxyurea 30mg\u002Fkg PO q day… Day -22: Campath-1H 3 mg IV or SQ... Day -21: Campath-1H 10 mg IV or SQ... Day -20: Campath-1H 15 mg IV or SQ... Day -19: Campath-1H 20 mg IV or SQ... Day -8: Fludarabine 30mg\u002Fm2 IV... Day -7: Fludarabine 30mg\u002Fm2 IV... Day -6: Fludarabine 30mg\u002Fm2 IV... Day -5: Fludarabine 30mg\u002Fm2 IV... Day -4: Fludarabine 30mg\u002Fm2 IV... Day -4: Thiotepa 8mg\u002Fkg IV… Day -3: Melphalan 140 mg\u002Fm2 IV... (dose modifications for patients \\\u003C10 kgs) Procedure\u002FSurgery: Hematopoietic stem cell infusion on day 0...",[16,22,26],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"GVHD Regimen A: UCB Recipients","Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg\u002Fkg IV Day +5: Abatacept 10mg\u002Fkg IV Day +14: Abatacept 10mg\u002Fkg IV Day +28: Abatacept 10mg\u002Fkg IV Day +60: Abatacept 10mg\u002Fkg IV Day +100: Abatacept 10mg\u002Fkg IV",[16,22,26],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"GVHD Regimen B: BM Recipients","Day -3: Begin Tacrolimus or cyclosporine Begin MMF Day -1: Abatacept 10mg\u002Fkg IV Day +1: Methotrexate 7.5mg\u002Fm2 IV Day +3: Methotrexate 7.5mg\u002Fm2 IV Day +5: Abatacept 10mg\u002Fkg IV Day +6: Methotrexate 7.5mg\u002Fm2 IV Day +14: Abatacept 10mg\u002Fkg IV Day +28: Abatacept 10mg\u002Fkg IV Day +60: Abatacept 10mg\u002Fkg IV Day +100: Abatacept 10mg\u002Fkg IV Day +180: Abatacept 10mg\u002Fkg IV Day +270: Abatacept 10mg\u002Fkg IV Day +365: Abatacept 10mg\u002Fkg IV",[9,16,22,26],[49],{"name":50,"affiliation":51,"role":52},"Shalini Shenoy, MD","Washington University School of Medicine (in St. Louis)","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Lissy Keller, CCRP","CONTACT","3142861168","kellerl@wustl.edu",{"name":60,"role":56,"phone":61,"phoneExt":35,"email":62},"Ian Snyder, CCRP","3142735953","ian.s@wustl.edu",[64,81,94,106,119,132,143,155,161,170,180,193,203,213,226,237,247,260,273,282,291,301,311,316,325,338,350,360],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Phoenix Children's Hospital","RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-112.07404,33.44838,{"lat":76,"lon":75},[79],{"name":80,"role":52,"phone":35,"phoneExt":35,"email":35},"Wilson A 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York","10032",{"type":73,"coordinates":252},[253,254],-74.00597,40.71427,{"lat":254,"lon":253},[257,259],{"name":258,"role":56,"phone":35,"phoneExt":35,"email":35},"Monica Bhatia, MD",{"name":258,"role":52,"phone":35,"phoneExt":35,"email":35},{"facility":261,"status":66,"city":262,"state":263,"zip":264,"country":70,"countryCode":71,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"University of North Carolina","Chapel Hill","North Carolina","27514",{"type":73,"coordinates":266},[267,268],-79.05584,35.9132,{"lat":268,"lon":267},[271],{"name":272,"role":52,"phone":35,"phoneExt":35,"email":35},"Andrew Gilman, MD",{"facility":274,"status":134,"city":275,"state":263,"zip":276,"country":70,"countryCode":71,"cosmosGeoPoint":277,"geoPoint":281,"contacts":35},"Carolinas Medical Center","Charlotte","28232",{"type":73,"coordinates":278},[279,280],-80.84313,35.22709,{"lat":280,"lon":279},{"facility":283,"status":134,"city":284,"state":263,"zip":285,"country":70,"countryCode":71,"cosmosGeoPoint":286,"geoPoint":290,"contacts":35},"Duke Children's Hospital","Durham","27705",{"type":73,"coordinates":287},[288,289],-78.89862,35.99403,{"lat":289,"lon":288},{"facility":292,"status":134,"city":293,"state":294,"zip":295,"country":70,"countryCode":71,"cosmosGeoPoint":296,"geoPoint":300,"contacts":35},"The University of Oklahoma","Oklahoma City","Oklahoma","73104",{"type":73,"coordinates":297},[298,299],-97.51643,35.46756,{"lat":299,"lon":298},{"facility":302,"status":134,"city":303,"state":304,"zip":305,"country":70,"countryCode":71,"cosmosGeoPoint":306,"geoPoint":310,"contacts":35},"University of Pittsburg","Pittsburgh","Pennsylvania","15224",{"type":73,"coordinates":307},[308,309],-79.99589,40.44062,{"lat":309,"lon":308},{"facility":312,"status":134,"city":313,"state":314,"zip":315,"country":70,"countryCode":71,"cosmosGeoPoint":35,"geoPoint":35,"contacts":35},"Cook Children's Hospital","Forth Worth","Texas","76104",{"facility":317,"status":134,"city":318,"state":314,"zip":319,"country":70,"countryCode":71,"cosmosGeoPoint":320,"geoPoint":324,"contacts":35},"Texas Transplant Institute","San Antonio","78229",{"type":73,"coordinates":321},[322,323],-98.49363,29.42412,{"lat":323,"lon":322},{"facility":326,"status":66,"city":327,"state":328,"zip":329,"country":70,"countryCode":71,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"University of Utah","Salt Lake City","Utah","84132",{"type":73,"coordinates":331},[332,333],-111.89105,40.76078,{"lat":333,"lon":332},[336],{"name":337,"role":52,"phone":35,"phoneExt":35,"email":35},"Michael Pulsipher, MD",{"facility":339,"status":134,"city":340,"state":341,"zip":342,"country":343,"countryCode":344,"cosmosGeoPoint":345,"geoPoint":349,"contacts":35},"BC Children's Hospital","Vancouver","British Columbia","V6H 3N1","Canada","CA",{"type":73,"coordinates":346},[347,348],-123.11934,49.24966,{"lat":348,"lon":347},{"facility":351,"status":134,"city":352,"state":353,"zip":354,"country":343,"countryCode":344,"cosmosGeoPoint":355,"geoPoint":359,"contacts":35},"University of Manitoba","Winnipeg","Manitoba","MB R3E 0T4",{"type":73,"coordinates":356},[357,358],-97.14704,49.8844,{"lat":358,"lon":357},{"facility":361,"status":134,"city":362,"state":35,"zip":35,"country":343,"countryCode":344,"cosmosGeoPoint":363,"geoPoint":367,"contacts":35},"University of Calgary","Calgary",{"type":73,"coordinates":364},[365,366],-114.08529,51.05011,{"lat":366,"lon":365},{"type":369,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[371],{"name":372,"class":6},"St. Louis Children's Hospital","100126972","phase-1-campathfludarabinemelphalan-transplant-conditioning-for-non-malignant-diseases-100126972",false,"NCT00920972","Campath\u002FFludarabine\u002FMelphalan Transplant Conditioning for Non-Malignant Diseases","A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Non-Malignant Disease Using a Reduced-Intensity Preparatory Regime","Inclusion Criteria:\n\nStratum 1: Patient must have non-malignant disorder, excluding thalassemia. Must be receiving a 8\u002F8 HLA-matched bone marrow, related or unrelated Stratum 2: Patient must have thalassemia receiving 8\u002F8 HLA-matched bone marrow or 5-8\u002F8 HLA-matched UCB. Related or unrelated.\n\nStratum 3: Patient must have a hemoglobinopathy receiving 7\u002F8 HLA-matched bone marrow or 5-8\u002F8 HLA-matched UCB. Related or unrelated.\n\nStratum 4: Patient must have a non-malignant disorder (excluding hemoglobinopathy) receiving 7\u002F8 HLA-matched bone marrow or 5-8\u002F8 HLA-matched UCB. Related or unrelated.\n\nAll strata:\n\n* Recipient age \\\u003C 21 years\n* Lansky\u002FKarnofsky \\>\u002F= 40\n* Adequate pulmonary, renal, liver, and other organ function as defined in protocol\n* Negative pregnancy test\n* Adequate total nucleated cell or CD34+ dose of product as defined in protocol\n* If sickle cell, Hemoglobin S \\\u003C30%\n\nExclusion Criteria:\n\n* HIV positive\n* Invasive infection\n* Pregnancy\u002Flactating","ALL","20 Years",{"count":383,"type":384},220,"ESTIMATED","INTERVENTIONAL",[387,388],"PHASE1","PHASE2","The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.",[391,392,393,394],"Metabolic Disorders","Hematologic, Immune, or Bone Marrow Disorders","Hemoglobinopathies","Non-malignant Disorders",[396,397,398,399,400,401,402,403,404,405,406,407],"Bone marrow","Transplant","Transplantation","Hematopoietic","Umbilical cord","Related","Unrelated","Reduced","Non-myeloablative","Nonmyeloablative","Non-malignant","Nonmalignant","2026-03-24",{"date":410,"type":411},"2026-03-25","ACTUAL",{"date":413,"type":411},"2001-12",{"date":415,"type":384},"2031-12",{"name":5,"class":6},28]