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NCT07717164Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 28 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
51 (estimated)
First submitted
16 Jul 2026
Start date
31 Jul 2026
Primary completion date
20 Sept 2026
Lead sponsor
Miltenyi Biomedicine GmbH
NCT number
NCT07717164

What you commit to

  • Study type: Observational
  • Planned participants: 51
  • From 31 Jul 2026 to the primary completion date, 20 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who received PTCy with sirolimus (and not a CNI)

Other

  • Patients will be entered into this trial only if they meet none of the following criteria:
  • Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)
  • HLA \<8/8 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/MTX) or PTCy-based GVHD prophylaxis Arm B\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)
  • Patients who did not sign consent for research
  • Patient transplanted at a center that does not meet CIBMTR data quality standards
  • Use of CNI- or PTCy-based GVHD prophylaxis Arm C: Control CIBMTR population
  • Patients who did not sign consent for research
  • Patient transplanted at a center that does not meet CIBMTR data quality standards
  • Use of ATG and/or alemtuzumab
  • Use of ex vivo CD34 selection

Who the study is looking for

  • Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)
  • Patients who participated in the PRAISE-IR single center phase II study
  • Patient age at transplant: ≥ 1 year and \< 66 years
  • HLA 8/8 MRD or MUD
  • Conditioning intensity: myeloablative
  • Conditioning regimens: Model-based ATG with TBI/Thiotepa/Cyclophospamide (TBI/Thio/Cy) or Busulfan/Melphalan/Fludarabine (Bu/Mel/Flu).
  • 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
  • Patient age at transplant: ≥ 1 year and \< 66 years
  • Disease: Patients with AML, MDS, and ALL
  • HLA 8/8 MRD or MUD
  • Peripheral blood stem cell allograft
  • Conditioning intensity: myeloablative conditioning
  • Conditioning regimens: standard dose ATG (2.5 mg/kg/day 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
  • Patient age at transplant: ≥ 1 year and \< 66 years
  • Disease:Patients with AML, MDS, and ALL
  • HLA 8/8 MRD or MUD
  • Peripheral blood stem cell allograft
  • Conditioning intensity: myeloablative conditioning
  • Conditoning regmens: TBI/Thiotepa/Cyclophospamide (TBI/Thio/Cy) or Busulfan/Melphalan/Fludarabine (Bu/Mel/Flu) and standard dose ATG (2.5 mg/kg/day given on Day -4 and Day -3)
  • GVHD prophylaxis: ex vivo CD34 selection
  • Morphologic complete remission at the time of alloHCT Arm C: Control CIBMTR population
  • First AlloHCT in the US between 2021-2023
  • Patient age at transplant: ≥ 1 year and \< 66 years
  • Disease:Patients with AML, MDS, and ALL
  • HLA 8/8 MRD or MUD
  • Peripheral blood stem cell
  • Conditioning intensity: myeloablative conditioning
  • Conditioning regimens: Busulfan/Cyclophosphamide (Bu/Cy), Busulfan/Fludaranbine (Bu/Flu), Cyclophosphamide/TBI (Cy/TBI), TBI/Etopsoside
  • GVHD prophyalxis: / CNI or PTCy-based
  • CNI-based: CNI (tacrolimus or ciclosporin) plus MTX
  • PTCy-based: Cyclophosphamide on day +3 and +4 (50 mg/kg/d) combined with CNI and mycophenolate mofetil (MMF)

Age in the registry: 1 year to 66 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status		New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.