drugset / Trial / NCT07304011

Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent

NCT07304011

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.

Timeline

Start
2025-12-17
Primary completion
2027-12-01
Completion
2029-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified Intravenous
Subject Olutasidenib Small molecule Oral