MDACC Study No:2013-0321 ( NCT No: NCT01873703)
Title:A Phase II Randomized, Double-Blinded, Placebo-Controlled Study of Pracinostat in Combination with Azacitidine in Patients with Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk 2 or High-Risk Myelodysplastic Syndrome (MDS)
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:Azacitidine; Placebo; Pracinostat
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if pracinostat given with
azacitidine can control MDS better than azacitidine alone. The side effects of
this treatment will also be studied.

An extension phase has been added to this study allowing patients already
receiving pracinostat to continue to receive pracinostat if they feel they are
benefitting from treatment with pracinostat and azacitidine. You are being
invited to participate in this extension phase.

New data from this clinical study recently became available. These study
results showed that pracinostat in combination with azacitidine failed to
increase the complete remission rate expected with azacitidine alone.
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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:Azacitidine
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:MEI Pharma, Inc.
Return Visit:
Home Care:

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Physician Name:Guillermo Garcia-Manero
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:1-877-MDA-6789

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