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Trial Summary


Protocol No.CTO-KO-MEN-001
StatusOPEN TO ACCRUAL
Principal InvestigatorSayar, Hamid
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
DescriptionThis first-in-human (FIH) dose escalation will determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed AML who have failed or are ineligible for any approved standard of care therapies, including HSCT.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Refractory or relapsed AML defined as the reappearance of > 5% blasts in the bone marrow and who have failed or are ineligible for any approved standard of care therapies, including HSCT.
  • Patient doesn't have a diagnosis of acute promyelocytic leukemia.
  • Patient doesn't have a diagnosis of chronic myelogenous leukemia in blast crisis..
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesLeukemia, other
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu