Study for the Evaluation of a GVHD Negative Outcome Score (GNOS) in Matched Unrelated or Haploidentical Hematopoietic Stem Cell Transplant
Completed
Conditions studied: Hematopoietic Stem Cell Transplantation, Stem Cell Transplantation, Hematopoietic, Transplantation, Hematopoietic Stem Cell
In brief
Before considering high-GVHD Negative Outcome Score (GNOS) donor selection for routine clinical practice, this blinded prospective study will be carried out for assessment of severe GVHD (graft-versus-host-disease) reduction associated with selecting high-GNOS donors for allogeneic hematopoietic peripheral blood stem cell transplant. The objective of this prospective study is to show: (a) that GVHD reductions and donor availabilities as observed in the retrospective studies also apply to prospective samples that are collected and processed from on-going matched unrelated transplants, and (b) that high-GNOS donor selection readily fits into today's donor selection process, such as to facilitate access to the benefits of GVHD reduction. The prospective study is designed to be blinded, and will not involve specific donor selection nor any influence on clinical management or decision making by application of the GNOS technology. To determine if some GNOS models perform better than others across different clinical centers, or across different recipient / donor attributes, 4 different specific GNOS models will be evaluated. Bootstrap computational analyses have been carried out on the retrospective data for the 4 GNOS models and will be tested and validated in this prospective study.
Key facts
- Study ID
- NCT02414113
- Run by
- Washington University School of Medicine
- People needed
- 113
- Starts
- 2015-03-25
- Expected to finish
- 2021-01-21
- Last updated by the study team
- 2021-02-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
- UNC Hospitals — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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