Experimental arm: pevonedistat in combination with azacitidine Control arm: azacitidine alone~With the following modifications:~Patients on the azacitidine arm and still MRD+ at 3 months but without hematological relapse can cross over to the combination arm~Cross over into the combination arm is possible any time up to 9 months of study treatment if initially responding patients (at 3 months) on AZA monotherapy become MRD positive again~Maximum treatment duration of 1 year~Patients receive pevonedistat at 20 mg/m2 i.v. (d1,3,5, q4w); azacitidine is given at a standard dose of 75 mg/m² i.v. or s.c. (d1-7 or 1-5,8,9, q4w)
MDS/AML with MRD and impending relapse after allogeneic stem cell transplantation and/or conventional chemotherapy