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



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:7/11/2018
Start Date:March 25, 2015
End Date:December 31, 2019
Contact:Mark A Schroeder, M.D.
Email:markschroeder@wustl.edu
Phone:314-454-8304

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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

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.

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.

Eligibility Criteria Prior to Unrelated Donor Search / Haploidentical Donor Identification:

- Recipient must be between 18 and 70 years of age, inclusive

- Recipient must be undergoing unrelated or haploidentical stem cell donor search with
one or more potential donors being requested for confirmatory typing and study
samples.

- Recipient must be able to understand and willing to sign written informed consent
document

Eligibility Criteria on Day 0:

- Selected donor must have agreed to participate in the trial and samples for GNOS must
have been received and processed.

- If MUD donor, selected donor must not be a C-antigen mismatch with the recipient
(C-allele mismatch donor-recipient pairs are eligible).

- Recipient must not have received alemtuzumab as part of stem cell conditioning
regimen.

- Recipient must not undergo transplantation with ex vivo T-cell depleted stem cells.

- If MUD donor, recipient must receive a myeloblative stem cell conditioning (MAC)
regimen per CIBMTR (Center for International Blood and Marrow Transplant Research)
criteria. Patients that receive only low intensity, non-myeloablative conditioning
regimen will be excluded.

- If haploidentical donor, recipient must receive standard MAC or RIC-conditioning with
post-transplant Cytoxan GVHD prophylaxis given on Days +3 and +4.

Enrollment will occur prior to the unrelated donor search. Following donor selection, if
the recipient does not meet the eligibility criteria listed for Day 0 or if the recipient
does not proceed to stem cell transplantation within 12 months of enrollment, the
donor/recipient pair will be non-evaluable for the study objectives. Non-evaluable
donor/recipient pairs will be removed from trial and replaced.
We found this trial at
4
sites
460 West 10th Avenue
Columbus, Ohio 43210
Principal Investigator: Steven Devine, M.D.
Phone: 614-366-6963
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Chapel Hill, North Carolina 27599
Principal Investigator: Thomas Shea, M.D.
Phone: 919-966-7746
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Mitchell Horwitz, M.D.
Phone: 919-668-1045
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-454-8304
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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