A Phase 2 Trial of Vorinostat in Combination with Azacitidine in Patients with Newly-Diagnosed Acute Myelogenous Leukemia or Myelodysplastic Syndrome who are ineligible for other Leukemia Protocols
The goal of this clinical research study is to learn if the combination of azacitidine and vorinostat can help to control AML or MDS better than azacitidine alone. The safety of this drug combination will also be studied.
Treatment Location: N/A
Primary: To 1) determine the effect of vorinostat in combination with 5-azacitidine versus 5-azacitidine alone on the 60 day survival of patients with untreated AML or MDS (Intermediate-1 or higher risk) who are ineligible for frontline studies and 2) the clinical activity of this combination in the above specified patient population. Secondary: To evaluate the safety and tolerability of this combination on this patient population, and the study the in vivo effect of this combination on methylation/acetylation status.
IRB Review and Approval Date: 09/08/2009
Recruitment Status: Closed
Projected Accrual: N/A