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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07130695
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olutasidenib Investigational Agent Administration — DRUG
    Twice daily olutasidenib maintenance therapy

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olutasidenib Investigational Agent Administration
    150 mg by mouth twice daily.

Primary Outcome Measure

Assess the feasibility of olutasidenib after upfront acute myeloid leukemia (AML) therapy with intensive induction and/or consolidation in IDH1 mutant AML. [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Massey CTO Heme Team
804-628-6430
Keri Maher, DO (PRINCIPAL_INVESTIGATOR)

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