Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk MDS (Myelodysplastic Syndrome) (IMDS001)

Inclusion Criteria:

• Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Patient is older than 18 years at the time of signing the informed consent.
• Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable double method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• Female of childbearing potential must have a negative serum β-human chorionic gonadotropin ( beta sub unit-HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential.
• Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of thalidomide therapy.
• Patient was diagnosed with myelodysplastic syndrome INT-2 or High risk according IPSS score .Bone marrow aspiration examination including cytogenetics performed up to 12 months before patient signing informed consent.
• Patient has a Performance Status 0-2 (WHO).
• Patient has a life-expectancy > 6 months
• Patient has not known active infectious hepatitis type B or C, or HIV infection.
• Patient is epopoietin resistant. Erythropoietin should be discontinued 28 days before starting treatment period.

• Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):

  • Platelet count ≥ 25 x 109/L without transfusion support within 7 days before the test.
  • Absolute neutrophil count (ANC) ≥ 0.5 x 109/L without the use of growth factors.
  • Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
  • Alanine transaminase (ALT): ≤ 2.5 x the ULN.
  • Total bilirubin: ≤ 1.5 x the ULN.
  • Serum creatinine< 2 X the ULN.

Exclusion Criteria:

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