Phase II Study of Clofarabine in Combination With Low Dose Cytarabine for Untreated Patients With Poor Risk Myelodysplastic Syndromes
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.