Study for the Evaluation of a GVHD Negative Outcome Score (GNOS) in Matched Unrelated or Haploidentical Hematopoietic Stem Cell Transplant
Condition: Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation, Hematopoietic; Transplantation, Hematopoietic Stem Cell
Study type: Observational

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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Matched unrelated hematopoietic stem cell transplant recipients
      
Biospecimen description: 
      -At the time of HLA confirmatory typing, 24 mL of whole blood will be collected from all
      potential donors who agree to participate.