[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380748":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":70,"collaborators":39,"id":72,"slug":39,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":39,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":39,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":39,"overallStatus":43,"whyStopped":39,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Northside Hospital, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GM-CSF post-transplant","EXPERIMENTAL","Sargramostim (GM-CSF) will start on Day +5 and continue until ANC \\>1000 x3 days or \\>1500 x1 day. GM-CSF will be administered not less than 24 hours after the last dose of cyclophosphamide and will be given at a dose of 250mcg\u002Fm2\u002Fday as an infusion over 2 hours.",[13,14],"Drug: Sargramostim","Other: Control Arm",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Sargramostim","250mcg\u002Fm2\u002Fday IV starting Day +5",[9],[22],"GM-CSF",{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Control Arm","Standard G-CSF given to those who decline to receive GM-CSF",[9],[28],"G-CSF",[30],{"name":31,"affiliation":32,"role":33},"Melhem Solh, MD","Northside Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Stacey Brown, BA","CONTACT","404-780-7965",null,"stacey.brown@northside.com",[42],{"facility":32,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Atlanta","Georgia","30342","United States",{"type":49,"coordinates":50},"Point",[51,52],-84.38798,33.749,{"lat":52,"lon":51},[55,56,60,63,65,67,69],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":57,"role":37,"phone":58,"phoneExt":39,"email":59},"Caitlin Guzowski, MBA, MHA","404-851-8523","caitlin.guzowski@northside.com",{"name":61,"role":62,"phone":39,"phoneExt":39,"email":39},"H. Kent Holland, MD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":39,"phoneExt":39,"email":39},"Asad Bashey, MD",{"name":66,"role":62,"phone":39,"phoneExt":39,"email":39},"Lawrence E Morris, MD",{"name":68,"role":62,"phone":39,"phoneExt":39,"email":39},"Scott Solomon, MD",{"name":31,"role":33,"phone":39,"phoneExt":39,"email":39},{"type":71,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100380748",false,"NCT04237623","GM-CSF With Post-Transplant Cyclophosphamide","Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post-Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells and With Post Transplant Cyclophosphamide","Inclusion Criteria:\n\n* Availability of 5\u002F10 to 8\u002F10 matched related donor\n* KPS \\>\u002F= 70%\n* CML, AML, MDS, ALL, CLL, HD, NHL, MPS\u002FCMML, MM, any other hematologic condition deemed an eligible indication for allogeneic transplant by the treating center\n\nExclusion Criteria:\n\n* Poor cardiac, pulmonary, liver, and renal function\n* HIV-positive\n* Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent\n* History of severe or serious allergic reaction to human GM-CSF or yeast-derived products","ALL","18 Years","78 Years",{"count":82,"type":83},38,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.",[89],"Transplant-Related Hematologic Malignancy","2026-04-15",{"date":92,"type":93},"2026-04-16","ACTUAL",{"date":95,"type":93},"2020-05-18",{"date":97,"type":83},"2026-09-18",{"name":5,"class":6},1]