Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

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 wi

Trial Details

NCT ID
NCT07471841
Phase
PHASE2
Sponsor
Timothy Pardee
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Olutasidenib
  • Azacitidine (AZA)
Locations (sample)
  • Winston-Salem, North Carolina, United States|36.09986,-80.24422

Key Eligibility Criteria

  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be…
  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of ≤ 2 within 28 days prior to registration.
  • Must have histologically or cytologically documented relapsed and/or refractory Acute Myeloid Leukemia (Refractory is defined as failure to achieve…

For full eligibility, visit ClinicalTrials.gov.

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