NCT04712942

Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat

Treatment of MDS/AML Patients With an Impending Hematological Relapse With Azacitidine Alone or in Combination With PEvonedistat - a Randomized Phase 2 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Acute Myeloid Leukemia in Remission
• Myelodysplastic Syndromes
• Minimal Residual Disease

Interventions

Type	Name	Description
DRUG	Pevonedistat	Patients receive pevonedistat at 20 mg/m2 i.v. (d1,3,5, q4w) up to 12 cycles
DRUG	Azacitidine	azacitidine is given at a standard dose of 75 mg/m² (d1-7 or 1-5,8,9, q4w) up to 12 cycles

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2021-01-19
• Last updated: 2023-08-21

Locations

14 sites across 1 country: Germany