Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00704704
Eligibility Criteria:
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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:
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00704704
Study Brief:
Protocol Section:
NCT00704704