Virginia Commonwealth University
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.
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
Inclusion Criteria: * 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 enroll…
Twice daily olutasidenib maintenance therapy
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