CLINICAL TRIAL SUMMARY

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 Status:Closed
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.

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Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:Azacitidine
Placebo
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Celgene Corporation
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Guillermo Garcia-Manero
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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