Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
1. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces
longer event free survival time in patients age > or = 60 years with untreated Acute Myeloid
Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for,
or not placed on, studies of new agents.
Secondary Objective:
1. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts
predicts response to either therapy or whether the ability of the 5 azacytidine + valproic
acid combination to induce demethylation or acetylation parallels response.