Triple Combination of Pevonedistat and Venetoclax Plus Azacitidine in Adults With Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

Summary

Participation Requirements

Description

The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people who have AML. This study will compare the improvement in EFS in Arm A: pevonedistat + venetoclax + azacitidine combination arm group when compared with Arm B: venetoclax + azacitidine. The study ...

The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people who have AML. This study will compare the improvement in EFS in Arm A: pevonedistat + venetoclax + azacitidine combination arm group when compared with Arm B: venetoclax + azacitidine. The study will enroll approximately 150 patients. Participants will be randomly assigned in 1:1 ratio to one of the two treatment groups in 28-day treatment cycles and which will remain disclosed to the patient and study doctor during the study: Pevonedistat 20 mg/m^2 + Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400mg) + Azacitidine 75 mg/m^2 Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400 mg) + Azacitidine 75 mg/m^2 This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 4 years. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner. Participants who discontinue study treatment without evidence of progressive disease (PD) will enter EFS follow-up or response follow-up (study visits every 3 months) or overall survival follow-up (contacted every 3 months to document subsequent therapies and survival status).

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