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Study for the Evaluation of a GVHD Negative Outcome Score (GNOS) in Matched Unrelated or Haploidentical Hematopoietic Stem Cell Transplant

NCT02414113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2021-02-04

No results posted yet for this study

Summary

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.

Conditions

  • Hematopoietic Stem Cell Transplantation
  • Stem Cell Transplantation, Hematopoietic
  • Transplantation, Hematopoietic Stem Cell

Sponsors & Collaborators

  • Predictive BioDiagnostics, LLC

    collaborator UNKNOWN

  • National Marrow Donor Program

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark A Schroeder, M.D. · Washington University School of Medicine

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2020-04-29
Completion
2021-01-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414113 on ClinicalTrials.gov