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

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.