NCT07471841

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

Pilot Single Arm Phase 2 Study of Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Timothy Pardee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• IDH1 Mutation
• Relapsed / Refractory AML

Interventions

Type	Name	Description
DRUG	Olutasidenib	Olutasidenib 150 mg orally twice a day
DRUG	Azacitidine (AZA)	Azacitidine 75 mg/m2 subcutaneously or IV (over 10-40 minutes)

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study