iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes

It is hypothesized that personalized treatment informed by computational biology simulation
technology will improve treatment outcomes for patients with relapsed or refractory MDS.

Inclusion Criteria:

- Provide written informed consent

- Must be at least 18 years of age

- Diagnosis of MDS, as defined by World Health Organization (WHO) 2008, that has
relapsed after any duration of time from last best response or is refractory to
induction therapy (defined as 4 cycles of treatment with a hypomethylating agent, 2
cycles of lenalidomide, 1 cycle of low intensity chemotherapy, or 1 cycle of high
intensity chemotherapy)

- ECOG performance status of 0-2

- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
sterile) may participate, provided they meet the following conditions:

1. Must agree to use physician-approved contraceptive methods (e.g., abstinence,
intrauterine device, oral contraceptive, double barrier device) throughout the
study and for 3 months following the last dose of study treatment; and

2. Must have a negative serum or urine pregnancy test within 7 days prior to
beginning treatment on this trial

- Males with female partners of child-bearing potential must agree to use physician
approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the
study and should avoid conceiving children for 6 months following the last dose of
study treatment.

Exclusion Criteria:

- Must not have acute myeloid leukemia (AML), as defined by WHO 2008

- Pregnant and nursing subjects are excluded because the effects of study treatments on
a fetus or nursing child are unknown

- Must not have had treatment with any anti-cancer therapy (investigational or standard)
within the previous 21 days prior to the first dose of study drug or less than full
recovery (no worse than CTCAE v4.0 grade 1) from the clinically significant toxic
effects of that treatment.