PRAISE-IR Versus CIBMTR Controls
Starting soon
Conditions studied: ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
In brief
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.
Key facts
- Study ID
- NCT07717164
- Run by
- Miltenyi Biomedicine GmbH
- People needed
- 51
- Starts
- 2026-07-31
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-07-28
Who can join
Age: 1 and older, up to 66. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Patients who received PTCy with sirolimus (and not a CNI)
- Use of ex vivo CD34 selection
Where it is running
- Memorial Sloan Kettering Cancer center — New York, New York, United States
Full record on ClinicalTrials.gov
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