drugset / Trial / NCT03745352

Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT03745352

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well pevonedistat works with azacitidine compared to azacitidine alone in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. It is not yet known if pevonedistat with azacitidine or azacitidine alone may work better in treating patients with acute myeloid leukemia.

Timeline

Start
2019-05-20
Primary completion
2021-08-19
Completion
2021-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified Intravenous
Subject Pevonedistat Small molecule Intravenous