Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia in Remission
- Minimal Residual Disease
- Myelodysplastic Syndromes
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: With Cross-Over optionMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 po...
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)
Tracking Information
- NCT #
- NCT04712942
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Investigators
- Principal Investigator: Uwe Platzbecker, Prof. Dr. University Leipzig
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