|MDACC Study No:||2012-0733 (clinicaltrials.gov NCT No: NCT01566695)|
|Title:||A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND STUDY TO COMPARE THE EFFICACY AND SAFETY OF ORAL AZACITIDINE PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN SUBJECTS WITH RED BLOOD CELL TRANSFUSION-DEPENDENT ANEMIA AND THROMBOCYTOPENIA DUE TO IPSS LOWER-RISK MYELODYSPLASTIC SYNDROMES|
|Principal Investigator:||Guillermo Garcia-Manero|
|Treatment Agent:||Azacitidine; Placebo |
|Study Description:||The goal of this clinical research study is to learn if patients with MDS need |
fewer blood transfusions if they take azacitidine, compared to a placebo. The
safety of the study drug will also be studied.
Azacitidine is designed to block proteins in cancer cells that stop the
function of tumor-fighting genes. When the drug blocks the "bad" proteins, the
tumor-fighting proteins may be able to work better.
A placebo is not a drug. It looks like the study drug, but is not designed to
treat any disease or illness. It is designed to be compared with a study drug
to learn if the study drug has any real effect.