Study of Clofarabine in Combination With Low Dose Cytarabine to Treat Myelodysplastic Syndromes (CLO2009AISSM05)

Inclusion Criteria:

• Male and female patients age 55 to 80 years
• Written informed consent to participate in the clinical trial
• Morphologically confirmed diagnosis of MDS according to WHO classification, and IPSS INT-2 or high risk according to IPSS index
• ECOG performance status 0-2
• No previous chemotherapy
• Serum bilirubin ≤1.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
• AST and ALT ≤2.5 times ULN
• Alkaline phosphatase ≤2.5 times ULN
• Serum creatinine ≤ 1 mg/dl: if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine) -1.154 x age in years -0-023 x 0.742 (if patient is female) x 1.212 (if patient is black)
• HIV negative

Exclusion Criteria:

• Have had any other chemotherapy or any investigational therapy as a treatment for MDS. Patients who received chemotherapy for other cancers than MDS/AML can be enrolled, provided that at least 6 months elapsed from accomplishment of the last course of chemo.
• Have had a prior hematopoietic stem cell transplant for MDS
• Have an uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
• Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
• Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart
• Have had any prior treatment with Clofarabine
• Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: 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.
• Have prior positive test for the Human Immunodeficiency Virus (HIV), HCV, HBV.