- Subjects must have failed hypomethylating treatment where "failure" is defined as: Progression (according to 2006 International Working Group [IWG] criteria) at any time after initiation of the hypomethylating treatment OR Failure to achieve complete or partial response or hematological improvement (HI) (according to 2006 IWG) after at least 4 cycles treatment OR Relapse after initial complete or partial response or HI (according to 2006 IWG criteria).