Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2031-01-01 -> 2027-12-01 2026-07-03
minor Completion moved earlier: 2032-01-01 -> 2029-12-01 2026-07-03
Trial Details
NCT Number NCT07304011
Lead Sponsor University of California, Davis
Collaborators: National Cancer Institute (NCI)
Conditions Acute Myeloid Leukemia
Enrollment 28 participants
Start Date 2025-12-17
Primary Completion 2027-12-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-02