5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome

The study drug, 5-azacytidine, is given daily intravenously for 7 days. After every 2 cycles
study participants will have a bone marrow test to evaluate the effect of the 5-azacytidine
on the Myelodysplastic Syndrome (MDS). Participants continue to get cycles of 5-Azacytidine
until 2 bone marrow tests show the MDS has stopped responding to the treatment. At that time
they will undergo a transplant if a donor is available.

Inclusion Criteria:

- Patients fulfilling the following criteria will be eligible for study entry:

1. Diagnosis of MDS according to WHO criteria

2. Intermediate-2 or high risk by IPSS score

3. Clinically able to receive 5-Azacytidine

4. Serum bilirubin levels laboratory (ULN). Higher levels are acceptable if these can be attributed to
active hemolysis or ineffective erythropoiesis

5. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic
transaminase (SGPT) levels
6. Serum creatinine levels
7. Negative serum pregnancy test prior to 5-Azacytidine treatment for women of
childbearing potential

8. Women and men of childbearing potential agree to use contraception while
receiving treatment with 5-Azacytidine

9. Potentially eligible for allogeneic transplantation

10. No prior allogeneic transplant

11. Age 18 to 70, inclusive.

Exclusion Criteria:

1. Known or suspected hypersensitivity to 5-azacytidine or mannitol

2. Patients previously treated with 5-azacytidine or deoxyazacytidine

3. Pregnant or breast feeding

4. Patients with advanced malignant hepatic tumors