Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation (NCT07130695)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (17 items).
Location: Virginia Commonwealth University — Richmond, Virginia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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)
- Male participants who intend to donate sperm during the course of this study or for 3 months after last dose
- Participants receiving, or are expected to require during the study, any concomitant medications that may interfere with efficacy, metabolism, or safety of the investigational agent, including drugs known to cause QT prolongation. for which drug interactions with olutasidenib would be prohibitory
- Concurrent chemotherapy for non-AML malignancy that is expected to interfere with the efficacy, metabolism, or safety of the agent under investigation
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Virginia Commonwealth University — Richmond, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.