RecruitingAcute Myeloid Leukemia
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Virginia Commonwealth University
You may qualify if…
- ✓ Histologically or cytologically confirmed non-acute promyelocytic isocitrate dehydrogenase (1 IDH1) mutant acute myeloid leukemia (AML). IDH1 mutation may be identified by NGS or PCR based methods and identified at time of diagnosis or any other time point prior to enrollment.
- ✓ Completed induction and/or consolidation intended as per treating physician to reach complete response (CR),complete response with partial hematologic recovery (CRh), or complete response with incomplete hematologic recovery (CRi), or morphologic leukemia free state (MLFS) at time of study enrollment Patients must be within 90 days of their last cycle of upfront therapy.
- ✓ Age ≥18 years
- ✓ Calculated creatinine clearance (by Cockroft-Gault) ≥30 mL/min
- ✓ Total bilirubin ≤2 × upper limit of normal (ULN) Note: patients with Gilbert's syndrome may be included if total bilirubin is ≤3 × ULN and direct bilirubin is ≤2 × ULN
- ✓ Serum aspartate aminotransferase/ alanine aminotransferase (AST/ALT) ≤3 × ULN
- ✓ Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2 or KPS \>50%
- ✓ Able to take oral medications
You may not qualify if…
- ✕ History of hypersensitivity or allergic reaction to olutasidenib or its components
- ✕ Corrected Q-T interval (QTc) (Fredericia calculation) \> 450 ms (after corrective action is taken)
- ✕ History of Torsades de Pointes
- ✕ Any gastrointestinal condition thought by the treating investigator to impair oral absorption of medication
- ✕ Stem cell transplant eligible and planned within 60 days of study start date in the opinion of the treating investigator
- ✕ Uncontrolled intercurrent illness or infection (those with controlled human immunodeficiency virus (HIV), hepatitis, or other chronic infections are eligible)
- ✕ Female participants who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
- ✕ Nursing women, women of childbearing potential with positive pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. (Appropriate method(s) of contraception include oral or injectable hormonal birth control, IUD, and double-barrier methods)
Where it's recruiting
Virginia
Richmond
Source: ClinicalTrials.gov · NCT07130695 · last updated 2026-02-06