|MDACC Study No:||2013-0321 (clinicaltrials.gov 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 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.