Condition: IDH1 Mutation · Relapsed / Refractory AML · Sponsor: Timothy Pardee
This is a prospective, single-arm phase 2 pilot study to assess the response rate of IDH1 mutated relapsed/refractory acute myeloid leukemia (AML) patients who receive olutasidenib after progressing on venetoclax based regimens. Each cycle will last for 28 days. Patients will receive olutasidenib 150 mg orally twice daily Day 1 through Day 28. After 3 cycles of olutasidenib, azacitidine 75 mg/m2 given on Day 1 through Day 7 may be added at the discretion of the treating investigator if the patient has not achieved a complete remission. Subjects with at least a PR after 6 cycles of treatment will continue treatment as previously described. Subjects without at least a partial response (PR) after 6 cycles of treatment will move to long term follow up.
This description comes directly from the study's public registry record.
Timothy Pardee · MD, PhD · Timothy.Pardee@wfusm.edu
Ahran Lee · 317-634-5842 · alee@hoosiercancer.org
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| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07471841