Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)

The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation. Bleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die. The main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who

Trial Details

NCT ID
NCT07223814
Phase
PHASE3
Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Bleximenib
  • Cytarabine
  • Daunorubicin or Idarubicin
  • Placebo
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orlando, Florida, United States|28.53834,-81.37924
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Kansas City, Kansas, United States|39.11417,-94.62746

Key Eligibility Criteria

  • ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informe…
  • New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 20…
  • Considered eligible for intensive chemotherapy.
  • WHO/ECOG performance status ≤2.

For full eligibility, visit ClinicalTrials.gov.

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