Vosaroxin and Azacitidine in Treating Patients With Myelodysplastic Syndromes

Inclusion Criteria:

- Diagnosis of myelodysplastic syndrome and one of the following:

- Cytopenias requiring red blood cell and/or platelet transfusions or neutropenia
(ANC <1 X109/L)

- IPSS score of INT-1 or higher at screening

- MDS with excess blasts in transformation as defined by FAB criteria (20-29% bone
marrow blasts) or

- Chronic myelomonocytic leukemia

- Age ≥18 years old

- Adequate renal and hepatic function defined as all of the following:

- total bilirubin ≤ 2.0 mg/dl, except in cases of Gilbert's disease;

- AST and ALT ≤2.5 institutional ULN;

- serum creatinine within normal institutional limits or estimated creatinine
clearance ≥60 mL/min/1.73 m2 by the Cockcroft-Gault equation

- ECOG performance status ≤2

- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).

- Females must be surgically or biologically sterile or postmenopausal or if of
childbearing potential, must agree to use an adequate method of contraception during
the study until 30 days after the last treatment. Males must be surgically or
biologically sterile or agree to use an adequate method of contraception during the
study until 30 days after the last treatment. Should a woman become pregnant or
suspect she is pregnant while participating in this study, she must inform her
treating physician immediately.

- Patients may have received up to 3 prior cycles of hypomethylator therapy (i.e.
decitabine or azacitidine) prior to enrollment and may have received supportive care
measures (growth factors, erythropoietin stimulating agents, transfusion, etc.

- Either enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic
Progression Factors in Hematologic Diseases"), which facilitates collection of blood,
bone marrow, and skin for correlative studies, or consents to collection of blood,
bone marrow, and skin as part of this protocol.

Exclusion Criteria:

- Prior treatment with four or more cycles of hypomethylator therapy.

- Receiving concomitant chemotherapy, radiation therapy, or immunotherapy during the
duration of treatment on protocol.

- Known seropositivity for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B virus vaccine are eligible. Patients who are
seropositive for HCV, but have a negative viral load are also eligible. Documentation
that the patients have completed a course of therapy for HCV is required and will be
obtained.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant and/or breastfeeding.