Status:
UNKNOWN
Safety and Efficacy of Azacitidine, and Thalidomide in Higher Risk MDS (Myelodysplastic Syndrome)
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study Objectives The aim of the study is to evaluate the safety and efficacy of the combination of 5-Aza-Cytidine + Thalidomide on the course of hrMDS patients. Primary end point: • To evaluate the ...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
- \-
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00704704
Start Date
September 1 2008
End Date
April 1 2011
Last Update
June 25 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hematolpgical department Tel Aviv Medical Center
Tel Aviv, Israel