NCT07130695

Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation

Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatment with olutasidenib for isocitrate dehydrogenase 1 (IDH1) mutant acute myeloid leukemia (AML) after completion of traditional intensive induction/consolidation is likely to be safe, tolerable, and may provide clinical benefit in terms of maintenance of remission and perhaps improvement in survival.

Detailed description

Up to 15 participants will receive treatment with olutasidenib 150 mg by mouth twice daily for up to 2 years. Participants will be regularly monitored for toxicities, adverse events, quality of life (QOL), and disease status. Once off treatment, participants will continue to be followed for a maximum of 2 years from date of enrollment for survival endpoints

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Olutasidenib Investigational Agent Administration	Twice daily olutasidenib maintenance therapy

Timeline

• Start date: 2026-02-02
• Primary completion: 2028-10-31
• Completion: 2030-10-31
• First posted: 2025-08-19
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study