Myelodysplastic Syndromes Clinical Trial
Official title:
Treatment of MDS/AML Patients With an Impending Hematological Relapse With Azacitidine Alone or in Combination With PEvonedistat - a Randomized Phase 2 Trial
MDS/AML with MRD and impending relapse after allogeneic stem cell transplantation and/or conventional chemotherapy
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) ;
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