drugset / Trial / NCT04203316

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

NCT04203316

Phase 2 Active not recruiting 1 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects of enasidenib and sees how well it works in treating pediatric patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for leukemia cell growth.

Timeline

Start
2023-08-14
Primary completion
2025-09-30
Completion
2026-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Enasidenib Small molecule Oral