Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.

Trial Details

NCT ID
NCT06429449
Phase
PHASE1
Sponsor
University of Colorado, Denver
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Venetoclax
  • Azacitidine
  • Mitoxantrone
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Subject must have confirmation of non-APL AML by WHO criteria and have been treated with first-line venetoclax/HMA (azacitidine or decitabine).
  • Subject must have relapsed disease per IWG criteria or disease refractory to first line venetoclax/HMA defined by less than a PR response after ≥ 1…
  • Subject must have either measurable residual disease (MRD+), as measured by FDA-approved flow cytometric test performed by Hematologics (cohort 3 a…
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2.

For full eligibility, visit ClinicalTrials.gov.

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