Study of SGI-110 in Elderly Acute Myeloid Leukemia (AML)

Length of Study:

You will receive the study drug(s) for up to 24 months. You will be taken off study if the
doctor thinks it is in your best interest, if the disease gets worse, if you experience any
intolerable side effects, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up visits.

Study Groups and Drug Administration:

As of February 2017,if you are found to be eligible to take part in this study, you will be
randomly assigned (as in a roll of dice) to 1 of 2 study groups. You will have an equal
chance of being assigned to each of the groups. Neither you nor the study staff can choose to
which group you are assigned:

- If you are in Group A, you will receive SGI-110 alone for 5 days.

- If you are in Group B, you will receive SGI-110 for 5 days and idarubicin for 2 days.

SGI-110 will be given 1 time each day through a needle under the skin. Idarubicin will be
given 1 time each day by vein over up to an hour.

If you respond to the study drug(s) you can continue on the same schedule every 4 to 8 weeks,
depending on how you react to the study drug(s). These 4-8 week periods will be called study
cycles. The first few (up to 3) cycles will be called Induction Cycles. All cycles after this
will be called Maintenance Cycles. The doses of the drugs, or number of times you receive
them, may be reduced in the Maintenance Cycles.

Study Visits:

On Day 1 of every cycle (+/- 7 days), you will have a physical exam.

Every week, blood (about 1-2 teaspoons) will be drawn for routine tests until any point that
the disease appears to have gone away. After that, this blood draw will be every 2-8 weeks.
The study staff will let you know when you will need these blood draws.

On Day 15 (+/- 2 days) of Cycle 1, blood (about 2 teaspoons) will be drawn to check the
status of the disease.

On Day 28 (+/-7 days) of Cycle 1, you will have a bone marrow aspirate to check the status of
the disease. After that, you will have a bone marrow aspirate every 2 weeks (+/- 7 days)
until any point that the disease appears to not be responding. If the routine blood tests
show that there is still leukemia, you may not need to have the bone marrow samples
collected. If the disease has not appeared to have gone away after Cycle 2, the timing of
your next bone marrow aspirate will depend on the results of your blood tests.

Every 3-4 cycles (or whenever the doctor thinks it is needed), you will have either an ECHO
or a MUGA to check your heart function.

You will need to stay in Houston when you are receiving the study drug(s). When you have
study visits in which you are not receiving study drug(s), these tests can be performed by
your local doctor.

Follow-up Visits:

After your last dose of study drug, you will have follow-up visits. You will only have these
visits if the disease has responded to the study drug(s).

- Every month, blood (about 1 tablespoon) will be drawn for routine tests. These tests can
be performed by your local doctor.

- Every 6 months, you will return to Houston for a physical exam and blood (about 1
tablespoon) will be drawn for routine tests.

Inclusion Criteria:

1. Previously untreated AML patients, except those who have received prior therapy with
hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth
factors, biological or targeted therapies are allowed.

2. Age >/= 70 years

3. ECOG performance status
4. Sign a written informed consent form.

5. Adequate liver function (total bilirubin renal function creatinine clearance of >/= 50 mL/min (estimated by the Cockcroft-Gault
[C-G] formula).

6. Male patients must use an effective contraceptive method during the study and for a
minimum of 8 weeks after study treatment.

7. Baseline LVEF >/= 40%.

Exclusion Criteria:

1. Patients with >/= NYHA grade 3 heart disease as assessed by history and/or physical
examination.

2. Patients who received more than one full course of prior hypomethylating agents
azacitidine or decitabine

3. Have any other severe concurrent disease, or have a history of serious organ
dysfunction or disease involving the heart, kidney, liver, or other organ system that
may place the patient at undue risk to undergo treatment.

4. Patients with a systemic fungal, bacterial, viral, or other infection not controlled
(defined as exhibiting ongoing signs/symptoms related to the infection and without
improvement, despite appropriate antibiotics or other treatment).

5. Pregnant or lactating patients.

6. Any significant concurrent disease, illness, or psychiatric disorder that would
compromise patient safety or compliance, interfere with consent, study participation,
follow up, or interpretation of study results

7. Any concurrent malignancy (with the exception of exclusion # 8)

8. Exceptions to # 7: a) Patients with treated non-melanoma skin cancer, in situ
carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free
duration, are eligible for this study if definitive treatment for the condition has
been completed; b) Patients with organ-confined prostate cancer with no evidence of
recurrent or progressive disease based on prostate-specific antigen (PSA) values are
also eligible for this study if hormonal therapy has been initiated or a radical
prostatectomy has been performed