[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648064":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":19,"locations":25,"responsibleParty":38,"collaborators":10,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":10,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":10,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Miltenyi Biomedicine GmbH","INDUSTRY",[8,12,15,17],{"label":9,"type":10,"description":11,"interventionNames":10},"Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)",null,"CliniMACS CD34 Reagent System",{"label":13,"type":10,"description":14,"interventionNames":10},"Arm B: Standard ATG dosing CD34-selection (CIBMTR population)","Intervention: CliniMACS CD34 Reagent System",{"label":16,"type":10,"description":11,"interventionNames":10},"Arm B*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)",{"label":18,"type":10,"description":10,"interventionNames":10},"Arm C: Control CIBMTR population",[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Michaela Malchow","CONTACT","+49 15117151746","Michaela.Malchow@miltenyi.com",[26],{"facility":27,"status":10,"city":28,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":10},"Memorial Sloan Kettering Cancer center","New York","10021","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-74.00597,40.71427,{"lat":36,"lon":35},{"type":39,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100648064","praise-ir-versus-cibmtr-controls-100648064",false,"NCT07717164","PRAISE-IR Versus CIBMTR Controls","Comparison of the PRAISE -IR (\"Phase 2 Study of Personalized r-ATG (Rabbit Anti-thymocyte Globulin) Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT (Hematopoietic Cell Transplantation) \", NCT04872595) Study Population With CIBMTR Controls","Inclusion Criteria:\n\nArm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)\n\n* Patients who participated in the PRAISE-IR single center phase II study\n* Patient age at transplant: ≥ 1 year and \\\u003C 66 years\n* HLA 8\u002F8 MRD or MUD\n* Conditioning intensity: myeloablative\n* Conditioning regimens: Model-based ATG with TBI\u002FThiotepa\u002FCyclophospamide (TBI\u002FThio\u002FCy) or Busulfan\u002FMelphalan\u002FFludarabine (Bu\u002FMel\u002FFlu).\n* Morphologic complete remission at the time of alloHCT Arm B: Standard ATG dosing CD34-selection (CIBMTR population)\n* First AlloHCT in the US between 2021-2023\n* Patient age at transplant: ≥ 1 year and \\\u003C 66 years\n* Disease: Patients with AML, MDS, and ALL\n* HLA 8\u002F8 MRD or MUD\n* Peripheral blood stem cell allograft\n* Conditioning intensity: myeloablative conditioning\n* Conditioning regimens: standard dose ATG (2.5 mg\u002Fkg\u002Fday given on Day -4 and Day -3)\n* GVHD prophylaxis: ex vivo CD34 selection\n* Morphologic complete remission at the time of alloHCT Arm B\\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)\n* Patients in BMT CTN 1301, who received the CD34-selected graft\n* Patient age at transplant: ≥ 1 year and \\\u003C 66 years\n* Disease:Patients with AML, MDS, and ALL\n* HLA 8\u002F8 MRD or MUD\n* Peripheral blood stem cell allograft\n* Conditioning intensity: myeloablative conditioning\n* Conditoning regmens: TBI\u002FThiotepa\u002FCyclophospamide (TBI\u002FThio\u002FCy) or Busulfan\u002FMelphalan\u002FFludarabine (Bu\u002FMel\u002FFlu) and standard dose ATG (2.5 mg\u002Fkg\u002Fday given on Day -4 and Day -3)\n* GVHD prophylaxis: ex vivo CD34 selection\n* Morphologic complete remission at the time of alloHCT Arm C: Control CIBMTR population\n* First AlloHCT in the US between 2021-2023\n* Patient age at transplant: ≥ 1 year and \\\u003C 66 years\n* Disease:Patients with AML, MDS, and ALL\n* HLA 8\u002F8 MRD or MUD\n* Peripheral blood stem cell\n* Conditioning intensity: myeloablative conditioning\n* Conditioning regimens: Busulfan\u002FCyclophosphamide (Bu\u002FCy), Busulfan\u002FFludaranbine (Bu\u002FFlu), Cyclophosphamide\u002FTBI (Cy\u002FTBI), TBI\u002FEtopsoside\n* GVHD prophyalxis: \u002F CNI or PTCy-based\n* CNI-based: CNI (tacrolimus or ciclosporin) plus MTX\n* PTCy-based: Cyclophosphamide on day +3 and +4 (50 mg\u002Fkg\u002Fd) combined with CNI and mycophenolate mofetil (MMF)\n\nExclusion Criteria:\n\nPatients will be entered into this trial only if they meet none of the following criteria:\n\nArm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)\n\n* HLA \\\u003C8\u002F8 MRD or MUD Arm B: Standard ATG dosing CD34-selection (CIBMTR population)\n* Patients who participated in the PRAISE-IR study\n* Patients who did not sign consent for research\n* Patient transplanted at a center that does not meet CIBMTR data quality standards\n* Use of CNI-(Tac\u002FMTX) or PTCy-based GVHD prophylaxis Arm B\\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)\n* Patients who did not sign consent for research\n* Patient transplanted at a center that does not meet CIBMTR data quality standards\n* Use of CNI- or PTCy-based GVHD prophylaxis Arm C: Control CIBMTR population\n* Patients who did not sign consent for research\n* Patient transplanted at a center that does not meet CIBMTR data quality standards\n* Use of ATG and\u002For alemtuzumab\n* Patients who received PTCy with sirolimus (and not a CNI)\n* Use of ex vivo CD34 selection","ALL","1 Year","66 Years",{"count":51,"type":52},51,"ESTIMATED","OBSERVATIONAL","The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.",[56,57,58],"ALL (Acute B-Lymphoblastic Leukemia)","AML (Acute Myeloid Leukemia)","MDS (Myelodysplastic Syndrome)","NOT_YET_RECRUITING","2026-07-24",{"date":62,"type":63},"2026-07-28","ACTUAL",{"date":65,"type":52},"2026-07-31",{"date":67,"type":52},"2026-09-30",{"name":5,"class":6},1]