MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease

Human subjects that volunteer to participate in this study will be requested to have
approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These
time intervals include prior to conditioning regimen for transplant, the day of
transplantation, day +30, +60 and +100 after transplantation. If a given subject develops
acute graft-versus-host disease, a blood sample will be obtained at that time as well. The
amount of blood samples collected in an 8 week period will not exceed 50 ml and collection
will not occur more than twice a week. There will be no pregnant women or children involved
in the investigators study.

All patients involved in the study will be undergoing bone marrow transplant and pregnancy
screening is done in pre-transplant testing. This blood will be collected in lavender top,
EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.

Inclusion Criteria:

- Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who
present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after
transplantation as defined by skin, GI, and/or liver involvement that are confirmed by
biopsy, regardless of age

- Patients undergoing a matched, unrelated donor (8/8) or matched, related donor
transplant (6/6)

- Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow
transplant

- Patients who develop grade II-IV aGVHD

Exclusion Criteria:

- Patients who receive transplants from incompletely matched donors

- Patients who receive T cell depleted transplants

- Patients who receive haplo-identical transplants

- Pregnant Patients