drugset / Trial / NCT03862157

Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT03862157

Phase 1/2 Active not recruiting 40 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and pevonedistat may work better in treating patients with acute myeloid leukemia.

Timeline

Start
2019-02-27
Primary completion
2027-01-31
Completion
2027-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Subject Pevonedistat Small molecule 20 mg/m2 Intravenous
Subject Venetoclax Small molecule 200 mg Oral
Subject Venetoclax Small molecule 400 mg Oral