- Have either documented refractory or relapsed AML, or documented MDS of any risk group that has failed a hypomethylating agent (such as decitabine [Vidaza] and azacitidine [AZA]). (Therapy failure with a hypomethylating agent is defined as patients who have been sufficiently treated with hypomethylating agents without response in the opinion of the treating physician, or whose disease has progressed or relapsed while on a hypomethylating agent.) Has never been treated with CPI-613.