- Relapsed or refractory disease meeting the following criteria: (a) Primary refractory, ie, refractory to induction with a standard anthracycline-based regimen or a hypomethylating agent (e.g. decitabine or azacitidine) for patients ineligible for anthracycline-based therapy; (b) First relapse after a first complete remission (CR) lasting less than 12 months; or (c) Second or later relapse. Relapse is defined as the reappearance of leukemic blasts in the peripheral blood or ≥ 5% leukemic blasts in the bone marrow after prior achievement of a CR or CRi.