SGI-110 With Donor Lymphocyte Infusion (DLI) for Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing Post Allogeneic Stem Cell Transplantation (AlloSCT)

Study Treatment Administration:

If you are found to be eligible to take part in this study, you will receive SGI-110 as an
injection under the skin 1 time a day on Days 1-5 of each 28-day cycle. Day 1 is the first
day you will receive the study drug. You may receive up to 12 cycles of SGI-110.

The study doctor will tell you how long each of your cycles may be and when your next cycle
will start.

If the doctor thinks it is needed, your dose of SGI-110 may be changed or stopped during the
study.

Donor Lymphocyte Infusions:

On Day 6 of Cycles 2, 4, and 6, you will receive a donor lymphocyte infusion by vein over
about 10-30 minutes. If you have high-risk AML or MDS and you are receiving SGI-110 as
maintenance, you will not receive donor lymphocyte infusions.

Graft-versus-host disease (GVHD) may occur after the T-cell infusion. GVHD occurs when donor
cells attack the cells of the person receiving the stem cell transplant. If GVHD occurs, you
will be given standard drugs that may help control GVHD. You may ask the study staff for
information about how the drugs are given and their risks. You cannot continue to receive the
study drug until the GVHD is controlled. The study doctor will discuss this with you.

Study Visits:

Within 3 days before the start of each cycle, on Day 3 of each cycle, and then one time
during Weeks 2 and 3 of each cycle (if the doctor thinks it is needed), blood (about 2
tablespoons) will be drawn for routine tests and to check your kidney and liver function.
Part of this blood sample will be used for a pregnancy test if you can become pregnant. Urine
may also be collected for this pregnancy test.

You may be able to have these blood draws performed at a local lab or clinic closer to your
home. The results of these tests will be sent to the study doctor at MD Anderson for review.
Talk with the study doctor about this possibility.

On Day 28 of Cycles 1, 2, 4, and 6 or on Day 100 and then at 6 months and 1 year after the
stem cell transplant (if you have high-risk AML or MDS):

- Blood (about 2 tablespoons) will be drawn for chimerism studies, which looks to see how
much the blood cells mixed between the donor and recipient. This test shows how well the
lymphocyte infusion has "taken."

- If the doctor thinks it is needed, you may have a bone marrow aspiration and biopsy
performed to check the status of the disease. To collect a bone marrow
aspiration/biopsy, an area of the hip is numbed with anesthetic, and a small amount of
bone marrow and bone is withdrawn through a large needle.

These tests/procedures may be performed more often, if you doctor thinks it is needed.

Length of Treatment:

You may receive up to 12 cycles of SGI-110. You may be taken off study early if the disease
gets worse, if intolerable side effects occur, if you develop uncontrolled or severe GVHD, or
if your doctor thinks it is in your best interest.

Inclusion Criteria:

1. Diagnosis of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (including
Chronic Myelomonocytic Leukemia [CMML]) according to WHO classification that underwent
first allogeneic HSCT with either peripheral blood or bone marrow as the source of the
hematopoietic stem cells.

2. Age 18 to 75 years old.

3. No more than 1 antigen mismatch at HLA-A, B, C, DRB1 and DQB1 locus for either related
or unrelated donor.

4. High risk AML and MDS patients will be included. Cohort 1: Morphological relapse at
least 90 days after stem cell transplant: 1. MDS patients: Re-appearance of dysplastic
changes in the bone marrow, with or without increase in bone marrow last count, which
is pathologically consistent with myelodysplastic syndrome. 2. AML patients: Bone
marrow blast count >/= 5%.

5. (#4, continued): Cohort 2: Persistence or reappearance of minimal residual disease by
flow cytometry or cytogenetic or molecular testing while being in morphological
remission after allogeneic stem cell transplantation.

6. (#4, continued): Cohort 3: High risk AML and MDS patients who are in complete
remission morphologically with no evidence of minimal residual disease by flow
cytometry or cytogenetic or molecular testing after allogeneic stem cell
transplantation.

7. (#4, continued): MDS patients: 1. Cytogenetics consistent with poor or very poor risk
group by 5-risk classification. 2. Cytogenetics consistent with monosomal karyotype.
3. Bone marrow blast count > 5% but less than 20% at any time during their disease
course before HSCT. 4. Peripheral blood blast
8. (#4, continued): AML patients: 1. Cytogenetics and molecular features consistent with
adverse risk group. 2. Presence of minimal residual disease by multi-color flow
cytometry or cytogenetics or molecular studies at the time of HSCT. 3. Presence of
active disease defined as bone marrow blast count >5% but less than of HSCT. 4. Peripheral blood blast count
9. (#4, continued): Be able to start the drug therapy between 42 to 100 days following
allogeneic SCT. 1. No more than 1 prior allogeneic SCT. 2. Post-transplant bone marrow
consistent with complete remission with no evidence of minimal residual disease by
flow-cytometry or cytogenetics or molecular testing. 3. Adequate engraftment within 14
days prior to starting study drug: ANC >/= 1.0 x 10^9/L without daily use of myeloid
growth factor; and, platelet >/= 50 x 1^90/L without platelet transfusion within 1
week.

10. ECOG performance status of 0, 1, or 2.

11. Serum creatinine as defined by the Cockcroft-Gault Equation*. Males(mL/min):(140-age)*IBW(kg) /
72*(serum creatinine(mg/dl)). Females(mL/min): 0.85*(140-age)*IBW(kg) / 72*(serum
creatinine(mg/dl)).

12. Serum bilirubin
13. Aspartate transaminase (AST) or alanine transaminase (ALT)
14. Alkaline phosphatase
15. No active bleeding.

16. No uncontrolled GVHD.

17. No clinical evidence of life-threatening infection.

18. Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent.

19. HIV negative and HBs-Ag negative.

20. Negative serum or urine pregnancy test for women with reproductive potential. The only
subjects who will be exempt from this criterion are postmenopausal women (defined as
women who have been amenorrheic for > 12 months) or subjects who have been surgically
sterilized or otherwise proven sterile.

Exclusion Criteria:

1. Use of any anti-leukemic agents after relapse is documented (note that the use of
these anti-leukemic agents given as post-transplant maintenance therapy is allowed in
this study, e.g., subcutaneous or oral 5-Azacytidine or FLT3 inhibitors for
maintenance) for cohorts 1 and 2.

2. Bone marrow blast count >60% for cohort 1.

3. Use of any of the following after transplantation and prior to starting study therapy
for cohort 3: 1. Investigational agents/therapies. 2. Anti-leukemic agents given as
post-transplant maintenance therapy (e.g., subcutaneous or oral 5-Azacytidine or FLT3
inhibitors for maintenance).

4. Active acute GVHD grade II or higher.

5. Active chronic GVHD that is extensive.

6. Concurrent use of systemic immune suppressive other than calcineurin inhibitors and
sirolimus.

7. Active uncontrolled systemic fungal, bacterial or viral infection.

8. Symptomatic or uncontrolled arrhythmias.

9. Significant active cardiac disease within the previous 6 months, including: New York
Hear Association (NYHA) class III or IV congestive heart failure; Unstable angina or
angina requiring surgical or medical intervention, and/or; Myocardial infarction.

10. Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B
Virus (HBV) or Hepatitis C Virus (HCV).

11. Prior history of malignancies, other than MDS or AML, unless the subject has been free
of the disease for >/= 1 year. However, subjects with the following history/concurrent
conditions are allowed: Basal or squamous cell carcinoma of the skin; Carcinoma in
situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of
prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging
system).