Actively Recruiting
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Led by Virginia Commonwealth University · Updated on 2026-02-06
15
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
R
Rigel Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-acute promyelocytic IDH1 mutant acute myeloid leukemia (AML)
- Completed induction and/or consolidation therapy aiming for complete or partial remission or leukemia-free state
- Within 90 days of last cycle of upfront therapy
- Age 18 years or older
- Calculated creatinine clearance of at least 30 mL/min
- Total bilirubin less than or equal to 2 times upper limit of normal (ULN), with exceptions for Gilbert's syndrome
- Serum AST/ALT less than or equal to 3 times ULN
- ECOG performance status 0, 1, or 2 or Karnofsky Performance Status over 50%
- Able to take oral medications
- Women of childbearing potential agree to effective contraception during treatment and for at least 6 months after last dose
- Male participants sexually active with women of childbearing potential and not vasectomized agree to use barrier contraception and avoid sperm donation until 90 days after last dose
You will not qualify if you...
- History of allergic reaction to olutasidenib or its components
- Corrected QT interval over 450 ms after correction
- History of Torsades de Pointes
- Gastrointestinal conditions impairing oral drug absorption
- Planned stem cell transplant within 60 days of study start
- Uncontrolled illness or infection (controlled HIV, hepatitis, or chronic infections allowed)
- Pregnant women or those intending to donate eggs during or 6 months after treatment
- Nursing women or women with positive pregnancy test or unwilling to use contraception
- Male participants intending to donate sperm during or 3 months after treatment
- Use of medications interfering with olutasidenib's efficacy or safety including QT prolonging drugs
- Concurrent chemotherapy for non-AML cancers expected to interfere with study drug
- Receipt of non-intensive upfront therapy including HMA/Venetoclax
- Use of other targeted AML therapies including IDH1/IDH2, FLT3, BCL-2, or menin inhibitors
- Participation in another investigational drug trial within 4 weeks prior to enrollment
- Use of systemic corticosteroids above physiological doses except for specific exceptions
- Medical, psychological, or social conditions that may increase risk or limit adherence per investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
M
Massey IIT Research Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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