Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
Sponsor: Timothy Pardee • ClinicalTrials.gov ID: NCT07471841
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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.
Interventions
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Olutasidenib
(Drug)
Olutasidenib 150 mg orally twice a day
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Azacitidine (AZA)
(Drug)
Azacitidine 75 mg/m2 subcutaneously or IV (over 10-40 minutes)
Eligibility criteria
Conditions
Locations
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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