Clinical trial NCT01003678 (phase 1, status: terminated)
Conditions: myelodysplastic syndrome
ICD codes: D46.9, D46.C, D46.Z
Drugs: clofarabine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Reason stopped: 
    drug provider withdrew support
  
Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed written informed consent.

          -  Patients with MDS must have IPSS score that falls in the intermediate or high risk
             disease (intermediate 1 will have to be transfusion dependent).

          -  Patients may have received up to two prior therapies for MDS including one
             hypomethylating agent and/or a biologic agent (biologic agents include GM-CSF or
             equivalent, danazol or equivalent, Sunitinib, Revlimid, ATG, or a vaccine).

          -  Age ≥ 18

          -  Have adequate renal and hepatic functions as indicated by the following laboratory
             values:

               -  Serum creatinine ≤ 1 mg/dL; if serum creatinine >l mg/dL, then the estimated
                  glomerular filtration rate (GFR) must be >50 mL/min/1.73 m2 as calculated by the
                  Modification of Diet in Renal Disease equation.

               -  Serum bilirubin ≤1.5 mg/dL x upper limit of normal (ULN)

               -  Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 x ULN

               -  Alkaline phosphatase ≤2.5 x ULN

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent.

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment.

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

        Exclusion Criteria:

          -  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.

          -  Active CNS disease

          -  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).

          -  Pregnant or lactating patients.

          -  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.

          -  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:

               -  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.

               -  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 (HN).

          -  Have prior positive test for the Human Immunodeficiency Virus (HN).

          -  Have currently active gastrointestinal disease, or prior surgery that may affect the
             ability of the patient to absorb oral clofarabine.

          -  Patients taking proton pump inhibitors such as omeprazole (Prilosec®), lansoprazole
             (Prevacid®), or esomeprazole (Nexium®). Those who cannot stop taking these drugs
             should be switched to H2 blockers such as famotidine (Pepcid®)or ranitidine (Zantac®).

          -  Patients taking alternative medicines (such as herbal or botanical) are not permitted.