A Phase 2, Single Arm Study to Determine the Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk Myelodysplastic Syndrome
- Patient is, in the investigator(s) opinion, willing and able to comply with the
- 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consent may be withdrawn by the patient at any time without prejudice to their future
- 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
- 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.