NCT02414113

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

A Blinded, Prospective Non-Interventional Observational Study for the Evaluation of a GVHD Negative Outcome Score (GNOS) in Matched Unrelated or Haploidentical Hematopoietic Stem Cell Transplant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Enrollment of the recipient will occur prior to the unrelated donor search or haploidentical donor identification. FOR UNRELATED DONORS: When the unrelated donor search is formalized, the study team will submit a study participation request document to the NMDP for all potential donors that are being evaluated for an enrolled recipient. These documents will be relayed to the appropriate donor centers by the NMDP. This document informs the donor center that the potential donor's participation in this trial is being requested. The donor center then will approach the potential donor about participation in the trial. If the potential donor consents to participate, the required donor study samples will be obtained and shipped to the appropriate labs. This will conclude the potential donor's physical participation in the trial. The donor consent will be kept at the donor center and will not be provided to the investigator. FOR HAPLOIDENTICAL DONORS: Haploidentical donors will be identified by the transplant team caring for the recipient, and will follow the site's standard procedures for identification, HLA typing, and medical clearance for stem cell donation. Haploidentical donors will be approached by the transplant team or the study coordinator about participation in the trial. If the potential donor consents to participate, the required donor study samples will be obtained and shipped to the appropriate lab for processing prior to the start of growth factor for stem cell mobilization or prior to stem cell collection via bone marrow harvest. FOR ALL DONORS: At the time of HLA confirmatory typing, 24 mL of whole blood will be collected from donors.

Conditions

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

Timeline

• Start date: 2015-03-25
• Primary completion: 2020-04-29
• Completion: 2021-01-21
• First posted: 2015-04-10
• Last updated: 2021-02-04

Locations

4 sites across 1 country: United States