[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630889":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":57,"locations":63,"responsibleParty":78,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":82,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treo\u002FFlu with PTCy","EXPERIMENTAL","Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.",[13,14,15,16,17,18,19],"Drug: Treosulfan","Drug: Fludarabine","Radiation: Total Body Irradiation","Drug: Tacrolimus","Drug: Mycophenolate Mofetil","Drug: Cyclophosphamid","Biological: Stem Cell Infusion",[21,27,31,38,42,48,52],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Treosulfan","12 g\u002Fm2 administered intravenously over 2 hours on days -4, -3, and -2.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Fludarabine","Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology .",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"RADIATION","Total Body Irradiation","TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.",[9],[37],"TBI",{"type":22,"name":39,"description":40,"armGroupLabels":41,"otherNames":26},"Tacrolimus","Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg\u002FmL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg\u002FmL.",[9],{"type":22,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Mycophenolate Mofetil","All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.",[9],[47],"MMF",{"type":22,"name":49,"description":50,"armGroupLabels":51,"otherNames":26},"Cyclophosphamid","Cyclophosphamide 40 mg\u002Fkg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide).",[9],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":26},"BIOLOGICAL","Stem Cell Infusion","Given on day 0.",[9],[58],{"name":59,"role":60,"phone":61,"phoneExt":26,"email":62},"Christopher Graham, MD","CONTACT","612-625-3051","grah0329@umn.edu",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":26},"Masonic Cancer Center at University of Minnesota","RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-93.26384,44.97997,{"lat":76,"lon":75},{"type":79,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100630889","phase-2-mt2025-35-allogeneic-hematopoietic-stem-cell-transplantation-using-reduced-intensity-conditioning-treosulfan-and-fludarabine-with-post-transplant-cytoxan-ptcy-for-the-treatment-of-hematological-diseases-100630889",false,"NCT07493538","MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Patients 2-75 years of age\n* ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (\\\u003C 16 years) with appropriate organ criteria as below (in other inclusion criteria)\n* 5\u002F6 or 6\u002F6 related donor, OR a 5-8\u002F8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5\u002F10) related donor\n* adequate liver (no decompensated liver failure, Child Pugh A, AST\u002FALT \\\u003C5X ULN) and renal function (creatinine \\\u003C2.0)\n* absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%\n* DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Evidence of untreated\u002Funcontrolled HIV infection\n* Untreated active serious infection\n* Active CNS malignancy\n* CML in blast crisis not in a complete remission by abnormal blast count.\n* Less than 3 months since prior myeloablative transplant","ALL","2 Years","75 Years",{"count":90,"type":91},132,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","This is a Phase II study following subjects proceeding with Treosulfan (36g\u002Fm2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg\u002Fkg, tacrolimus and MMF for GVHD prophylaxis.",[97,98,99,100,101],"AML","MDS","Acute Leukemia","Acute Myeloid Leukemia","Myelodysplastic Syndromes","2026-04-13",{"date":104,"type":105},"2026-04-16","ACTUAL",{"date":107,"type":105},"2026-04-10",{"date":109,"type":91},"2035-03",{"name":5,"class":6},1]