[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07717164":3,"trial-entities:NCT07717164":112,"trial-summary:NCT07717164":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":90,"locations":94,"central_contacts":103,"overall_officials":109,"references":110,"see_also_links":111},"NCT07717164","PROJXXXX","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","NOT_YET_RECRUITING","2026-09-30","2026-07","2026-07-28","2026-07-31","Miltenyi Biomedicine GmbH","INDUSTRY",null,"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.","Comparison of the PRAISE -IR (\"Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT\", NCT04872595) study population with CIBMTR controls",[19,20,21],"ALL (Acute B-Lymphoblastic Leukemia)","AML (Acute Myeloid Leukemia)","MDS (Myelodysplastic Syndrome)",[],"OBSERVATIONAL",[],{"count":26,"type":27},51,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"Comparison of OS between PRAISE-IR study participants (Arm A) with CIBMTR control participants who have received a CD34 selected graft and standard dose ATG (Arm B) with the goal of demonstrating superiority of Arm A.","Comparison of overall survival (OS) between PRAISE-IR study participants (Arm A) with CIBMTR control participants who have received a CD34 selected graft and standard dose ATG (Arm B).\n\nNote: If the number of participants meeting the criteria for Arm B is insufficient for 1:1 matching, Arm A could be compared with the CD34 selection group from the BMT CTN1301 study (Arm B\\*).\n\nComparison of OS between PRAISE-IR study participants (Arm A) with CIBMTR control patients who have received standard of care (SoC) allogeneic hematopoietic stem cell transplantation (alloHCT) without CD34 selection with post transplantation cyclophosphamide (PTCy) and Calcineurin inhibitor (CNI)\u002FMethotrexate (MTX) for GVHD prophylaxis (Arm C).","two years",[35,38,41,43,45,47,49],{"measure":36,"description":37,"timeFrame":33},"Acute GVHD, grades II-IV","Acute Graft-versus-Host Disease (GVHD), grades II-IV",{"measure":39,"description":40,"timeFrame":33},"Chronic GVHD","Chronic Graft-versus-Host Disease (GVHD)",{"measure":42,"description":42,"timeFrame":33},"Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)",{"measure":44,"description":44,"timeFrame":33},"Rate of primary graft failure",{"measure":46,"description":46,"timeFrame":33},"Non-relapse mortality",{"measure":48,"description":48,"timeFrame":33},"Relapse",{"measure":50,"description":50,"timeFrame":33},"Relapse-free survival","ALL","1 Year","66 Years",false,{"inclusion":56,"exclusion":79,"raw_text":89},[57,58,59,60,61,62,63,58,64,59,65,66,67,68,69,70,58,71,59,65,66,72,68,73,63,58,71,59,74,66,75,76,77,78],"Patients who participated in the PRAISE-IR single center phase II study","Patient age at transplant: ≥ 1 year and \\\u003C 66 years","HLA 8\u002F8 MRD or MUD","Conditioning intensity: myeloablative","Conditioning regimens: Model-based ATG with TBI\u002FThiotepa\u002FCyclophospamide (TBI\u002FThio\u002FCy) or Busulfan\u002FMelphalan\u002FFludarabine (Bu\u002FMel\u002FFlu).","Morphologic complete remission at the time of alloHCT Arm B: Standard ATG dosing CD34-selection (CIBMTR population)","First AlloHCT in the US between 2021-2023","Disease: Patients with AML, MDS, and ALL","Peripheral blood stem cell allograft","Conditioning intensity: myeloablative conditioning","Conditioning regimens: standard dose ATG (2.5 mg\u002Fkg\u002Fday given on Day -4 and Day -3)","GVHD prophylaxis: ex vivo CD34 selection","Morphologic complete remission at the time of alloHCT Arm B\\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)","Patients in BMT CTN 1301, who received the CD34-selected graft","Disease:Patients with AML, MDS, and ALL","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)","Morphologic complete remission at the time of alloHCT Arm C: Control CIBMTR population","Peripheral blood stem cell","Conditioning regimens: Busulfan\u002FCyclophosphamide (Bu\u002FCy), Busulfan\u002FFludaranbine (Bu\u002FFlu), Cyclophosphamide\u002FTBI (Cy\u002FTBI), TBI\u002FEtopsoside","GVHD prophyalxis: \u002F CNI or PTCy-based","CNI-based: CNI (tacrolimus or ciclosporin) plus MTX","PTCy-based: Cyclophosphamide on day +3 and +4 (50 mg\u002Fkg\u002Fd) combined with CNI and mycophenolate mofetil (MMF)",[80,81,82,83,84,82,83,85,82,83,86,87,88],"HLA \\\u003C8\u002F8 MRD or MUD Arm B: Standard ATG dosing CD34-selection (CIBMTR population)","Patients who participated in the PRAISE-IR study","Patients who did not sign consent for research","Patient transplanted at a center that does not meet CIBMTR data quality standards","Use of CNI-(Tac\u002FMTX) or PTCy-based GVHD prophylaxis Arm B\\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)","Use of CNI- or PTCy-based GVHD prophylaxis Arm C: Control CIBMTR population","Use of ATG and\u002For alemtuzumab","Patients who received PTCy with sirolimus (and not a CNI)","Use of ex vivo CD34 selection","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",[91,92,93],"CHILD","ADULT","OLDER_ADULT",[95],{"facility":96,"city":97,"state":97,"zip":98,"country":99,"geoPoint":100},"Memorial Sloan Kettering Cancer center","New York","10021","United States",{"lat":101,"lon":102},40.71427,-74.00597,[104],{"name":105,"role":106,"phone":107,"email":108},"Michaela Malchow","CONTACT","+49 15117151746","Michaela.Malchow@miltenyi.com",[],[],[],{"nct_id":4,"conditions":113,"biomarkers":117},[114,115,116],"Acute B-Lymphoblastic Leukemia","Acute Myeloid Leukemia","Myelodysplastic Syndrome",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an observational study comparing two groups of patients. It aims to enroll 51 participants.","completed","Observational Study Comparing PRAISE-IR Participants with CIBMTR Controls for Blood Cancers","This observational study is comparing outcomes for patients who previously participated in the PRAISE-IR study with a group of control patients from the CIBMTR (Center for International Blood and Marrow Transplant Research) registry. The PRAISE-IR study involved a specific type of stem cell transplant using CD34-selected grafts and personalized dosing of ATG (anti-thymocyte globulin), which affects the RAF mechanism. This study aims to see if the PRAISE-IR approach leads to better overall survival compared to standard CD34-selected grafts with standard ATG. You might be able to join if you were in the original PRAISE-IR study, are between 1 and 66 years old, and had a specific type of stem cell transplant for acute B-lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or myelodysplastic syndrome (MDS). The study is looking to enroll 51 participants, but its current recruitment status is unclear.","The primary goal is to compare overall survival at two years.",139,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]