[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100272624":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":90,"collaborators":23,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":23,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":58,"whyStopped":23,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Northside Hospital, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Flu\u002FCy\u002FTBI","EXPERIMENTAL","Fludarabine, Cyclophosphamide, TBI followed by bone marrow transplantation. Post-transplant Cyclophosphamide will be on Days 3 \\& 4.",[13,14,15,16],"Drug: Fludarabine","Drug: Cyclophosphamide","Radiation: Total Body Irradiation","Drug: Rabbit ATG",[18,24,28,35,39],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Fludarabine","30 mg\u002Fm2 IV QD x 5 days (Days -6 to -2)",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Cyclophosphamide","14.5 mg\u002Fkg\u002Fday IV x 2 doses (Days -6 \\& -5)",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"RADIATION","Total Body Irradiation","300 cGy x1 dose (Day -1)",[9],[34],"TBI",{"type":19,"name":36,"description":37,"armGroupLabels":38,"otherNames":23},"Rabbit ATG","1.5 mg\u002Fkg\u002Fday x 3 days (Days -3 to -1)",[9],{"type":19,"name":25,"description":40,"armGroupLabels":41,"otherNames":23},"Post-transplant: 50 mg\u002Fkg IV QD (Day +3 to +4)",[9],[43],{"name":44,"affiliation":45,"role":46},"Melhem Solh, MD","Blood and Marrow Transplant Group of Georgia","PRINCIPAL_INVESTIGATOR",[48,52],{"name":44,"role":49,"phone":50,"phoneExt":23,"email":51},"CONTACT","404-255-1930","msolh@bmtga.com",{"name":53,"role":49,"phone":54,"phoneExt":23,"email":55},"Stacey Brown","404-851-8238","stacey.brown@northside.com",[57,72],{"facility":45,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Atlanta","Georgia","30342","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-84.38798,33.749,{"lat":68,"lon":67},[71],{"name":44,"role":49,"phone":50,"phoneExt":23,"email":51},{"facility":73,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Northside Hospital",{"type":65,"coordinates":75},[67,68],{"lat":68,"lon":67},[78,79,80,83,85,87,89],{"name":44,"role":49,"phone":50,"phoneExt":23,"email":51},{"name":53,"role":49,"phone":54,"phoneExt":23,"email":55},{"name":81,"role":82,"phone":23,"phoneExt":23,"email":23},"Scott Solomon, MD","SUB_INVESTIGATOR",{"name":84,"role":82,"phone":23,"phoneExt":23,"email":23},"H. Kent Holland, MD",{"name":86,"role":82,"phone":23,"phoneExt":23,"email":23},"Asad Bashey, MD, PhD",{"name":88,"role":82,"phone":23,"phoneExt":23,"email":23},"Lawrence Morris, MD",{"name":44,"role":46,"phone":23,"phoneExt":23,"email":23},{"type":91,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100272624","phase-2-haploidentical-bone-marrow-transplant-with-post-transplant-cyclophosphamide-for-patients-with-severe-aplastic-anemia-100272624",false,"NCT02828592","Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia","A Study of T-Cell Replete, HLA-Mismatched Haploidentical Bone Marrow Transplantation With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related Donor","Inclusion Criteria:\n\n* Availability of 3\u002F6 - 5\u002F6 matched (HLA-A, B, DR) related donor who must have negative HLA cross-match in the host vs. graft direction\n* Age \\\u003C= 65 years for previously treated and \\\u003C= 75 years for previously treated patients\n* KPS \\>= 70%\n* Aplastic Anemia that meets the following criteria:\n\nPeripheral Blood (must fulfill 2 of 3):\n\n* \\\u003C500 PMN\u002Fmm3\n* \\\u003C20,000 platelets\n* absolute reticulocyte count \\\u003C40,000\u002FmicroL\n\nBone Marrow (must be either):\n\n* markedly hypocellular (\\\u003C25% of normal cellularity)\n* moderately hypocellular with 70% non-myeloid precursors and patient meets peripheral blood criteria above\n\nExclusion Criteria:\n\n* poor cardiac function (LVEF \\\u003C40%)\n* poor pulmonary function (FEV1 \\& FVC \\\u003C50% predicted)\n* poor liver function (bili \\>= 2mg\u002FdL)\n* poor renal function (creatinine \\>= 2.0mg\u002FdL or creatinine clearance \\\u003C40mL\u002Fmin)\n* prior allogeneic transplant","ALL","1 Year","75 Years",{"count":103,"type":104},20,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","Severe aplastic anemia is a rare and serious form of bone marrow failure related to an immune-mediated mechanism that results in severe pancytopenia and high risk for infections and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance of survival; however, a response rate with just immunosuppression for those patients lacking suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1\u002F3 of patients are cured, 1\u002F3 are dependent on long term immunosuppression, and the other 1\u002F3 relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical donor for transplantation has good response rates and significantly lower rates of acute and chronic GVHD.",[110],"Severe Aplastic Anemia",[112],"SAA","2026-04-15",{"date":115,"type":116},"2026-04-20","ACTUAL",{"date":118,"type":116},"2016-09-09",{"date":120,"type":104},"2028-08-31",{"name":5,"class":6},2]