At a glance
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Phase II Study of the Combination of 5-azacytidine With Valproic Acid and All-trans Retinoic Acid in Patients With High Risk Myelodysplastic Syndrome and Acute Myelogenous Leukemia
In Brief
A Phase 2 clinical trial evaluating 5-Azacytidine (5-aza), Valproic Acid, and 1 other intervention for Myelodysplastic Syndrome and Acute Myelogenous Leukemia. Completed, enrolled 34 participants across 1 site.
Detailed Summary
5-aza is a chemotherapy drug with activity in leukemia and myelodysplastic syndromes (MDS). Researchers hope that valproic acid (VPA) and all-trans retinoic acid (ATRA)will increase the effects of 5-aza. The goal of this clinical research study is to find the highest safe dose of valproic acid (VPA) that can be given in combination with 5-azacytidine (5-aza) and all-trans retinoic acid (ATRA) in the treatment of AML and MDS. The safety and effectiveness of this combination therapy will also be studied. Additional blood and bone marrow samples will be requested. These samples will be used to evaluate the effect of the treatment on leukemic cells. In addition, any leftover blood and bone marrow samples that are collected at the start of the study and during the regularly scheduled evaluations to be sent for research studies. The research studies will examine changes in the blood and bone marrow cells that might help explain the causes of leukemia and MDS and how the combination of 5-aza, VPA, and ATRA works.
Study Details
Timeline
Interventions
Start at 75 mg/m\^2 subcutaneously daily for 7 days.
50 mg/kg daily by mouth for 7 days, same days as 5-aza.
45 mg/m\^2 orally daily (in two divided doses) for 5 days starting on day 3 of the administration of 5-aza and VPA.