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.
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
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
Disease: Patients with AML, MDS, and ALL
Other
Retrospective
Not listed
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). Note: 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\*). Comparison 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)/Methotrexate (MTX) for GVHD prophylaxis (Arm C).
Acute GVHD, grades II-IV
Acute Graft-versus-Host Disease (GVHD), grades II-IV
Chronic GVHD
Chronic Graft-versus-Host Disease (GVHD)
Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)
Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment)
Rate of primary graft failure
Rate of primary graft failure
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