Clinical Trial

Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia

Active, Not Recruiting Phase 1
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Summary
The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes. The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control the disease. The safety and effects of this combination will also be studied in both parts.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-08-11
notable Enrollment increased: 20 -> 32 participants 2026-08-11
Trial Details
NCT Number NCT07411586
Lead Sponsor M.D. Anderson Cancer Center
Conditions Acute Myeloid Leukemia
Enrollment 32 participants
Start Date 2026-05-28
Primary Completion 2027-01-14 (estimated)
Study Completion 2029-01-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-10