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Clinical Trial Summary

MDS/AML with MRD and impending relapse after allogeneic stem cell transplantation and/or conventional chemotherapy


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04712942
Study type Interventional
Source University of Leipzig
Contact
Status Completed
Phase Phase 2
Start date January 1, 2021
Completion date January 31, 2023

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