Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens. Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission. Subjects with at least a PR after 6 cycles of treatment will continue treatment as previously described. Subjects without at least a partial response (PR) after 6 cycles of treatment will move to long term follow up.

NCT Number	NCT07471841
Lead Sponsor	Timothy Pardee Collaborators: Atrium Health Wake Forest Baptist, Rigel Pharmaceuticals
Conditions	IDH1 Mutation, Relapsed / Refractory AML
Enrollment	25 participants
Start Date	2026-07
Primary Completion	2028-06 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-26