At a glance
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A Randomized Phase II Study of the Combination of 5-Azacytidine With Valproic Acid (VPA) Versus Low-Dose Ara-C in Patients With AML/MDS Not Eligible for Other Studies
In Brief
A Phase 2 clinical trial evaluating 5-Azacytidine, Ara-C, and 1 other intervention for Acute Myelogenous Leukemia and 2 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
75 mg/m\^2 daily for 7 days (days 1-7) via subcutaneous injection.
20 mg twice daily via subcutaneous injection for 10 days.
50 mg/m\^2 orally daily days 1-7.