[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577507":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":74,"collaborators":28,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":28,"enrollmentInfo":86,"targetDuration":28,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Nebraska","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Attenuated-dose post-transplant cyclophosphamide (PTCy) Arm","EXPERIMENTAL","Participants will receive attenuated-dose post-transplant cyclophosphamide (PTCy) at 25 mg\u002Fkg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis.",[13,14,15],"Drug: Attenuated-dose Cyclophosphamide","Drug: Sirolimus","Drug: Mycophenolate Mofetil (MMF)",{"label":17,"type":18,"description":19,"interventionNames":20},"High-dose post-transplant cyclophosphamide (PTCy) Arm: Standard of Care","ACTIVE_COMPARATOR","Participants will receive high-dose post-transplant cyclophosphamide (PTCy) at 50 mg\u002Fkg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for GVHD prophylaxis.",[21,14,15],"Drug: High-dose Cyclophosphamide",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Attenuated-dose Cyclophosphamide","Cyclophosphamide administered at an attenuated dose of 25 mg\u002Fkg on days +3 and +4 post-transplant for GVHD prophylaxis.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"High-dose Cyclophosphamide","Cyclophosphamide administered at the standard high dose of 50 mg\u002Fkg on days +3 and +4 post-transplant for GVHD prophylaxis.",[17],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Sirolimus","Sirolimus is started on day +5 with a loading dose of 6 mg, followed by a maintenance dose of 2 mg daily, adjusted to target trough levels of 8-12 ng\u002FmL. Sirolimus taper is recommended to start at day +90 and to be completed by day +180, provided there is no evidence of acute GVHD.",[9,17],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Mycophenolate Mofetil (MMF)","MMF is started on day +5 at a dose of 15 mg\u002Fkg per dose (maximum 1 g per dose) three times daily. MMF is generally discontinued by day +35 in the absence of GVHD.",[9,17],[42],{"name":43,"affiliation":5,"role":44},"Moataz Ellithi, MBChB","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Taylor Johnson","CONTACT","402-559-4596","taylora.johnson@unmc.edu",{"name":52,"role":48,"phone":49,"phoneExt":28,"email":53},"IIT OFFICE","iitoffice@unmc.edu",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"University of Nebraska Medical Center","RECRUITING","Omaha","Nebraska","68198","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-95.94043,41.25626,{"lat":67,"lon":66},[70,71,73],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},{"name":72,"role":48,"phone":28,"phoneExt":28,"email":28},"A",{"name":43,"role":44,"phone":28,"phoneExt":28,"email":28},{"type":75,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100577507","phase-2-optimizing-gvhd-prophylaxis-after-allogeneic-hematopoietic-cell-transplantation-100577507",false,"NCT06799195","Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation","A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial","PTCYGVHD","Inclusion criteria:\n\n* Adults aged 60 years or older\n* Diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation\n* Planned to receive any reduced-intensity conditioning regimen (any graft source is acceptable) and availability of human leukocyte antigen (HLA)-matched donor at HLA loci A, B, C, and HLA-DR beta chain antigen (DRB1)\n* Karnofsky Performance Status (KPS) of 70% or higher.\n\nExclusion criteria:\n\n* Previous history of one or more prior allogeneic stem cell transplants (i.e., second or third allogeneic transplant)\n* Planned use of high doses of cyclophosphamide (e.g., a total cyclophosphamide dose of approximately 50 mg\u002Fkg or more) as part of the conditioning regimen prior to allogeneic stem cell transplant. A lower dose of cyclophosphamide (e.g., fludarabine, cyclophosphamide, and low-dose total body irradiation regimen that uses 2 doses of cyclophosphamide at 14.5 mg\u002Fkg) is acceptable.\n* Known diagnosis of liver cirrhosis or other advanced liver disease that may impact cyclophosphamide metabolism.\n* Diagnosis of myelofibrosis\n* Creatinine clearance less than 40 mL\u002Fmin\u002F1.73 m², which may increase the risk of hemorrhagic cystitis with post-transplant cyclophosphamide (PTCy)\n* Systolic cardiac dysfunction with an ejection fraction of less than 45%.\n* Use of a haploidentical or mismatched donor.\n* Any other condition judged by the physician to increase the risk of toxicities associated with PTCy.","ALL","60 Years",{"count":87,"type":88},126,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","This study will compare post-transplant health-related quality of life following the use of standard versus attenuated dose of post-transplant cyclophosphamide in addition to two-drug graft-versus-host disease (GVHD) prophylaxis among recipients of allogeneic hematopoietic stem cell transplant.",[94,95],"Hematological Malignancies","Graft-versus-Host Disease (GVHD)",[97,98,34,38,99,100],"Allogeneic Hematopoietic Stem Cell Transplantation","GVHD Prophylaxis","Health-Related Quality of Life (HRQoL)","Randomized Controlled Trial","2025-12-08",{"date":103,"type":104},"2025-12-15","ACTUAL",{"date":106,"type":104},"2025-06-23",{"date":108,"type":88},"2031-11",{"name":5,"class":6},1]