Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML

Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need. The combination therapy with two medicines, azacitidine and venetoclax, is the usual plan of action. This has brought significant progress in the treatment, but it nevertheless is not curative and the disease does relapse over time. Revumenib blocks a specific molecule called menin in the cell nucleus. Some types of AML are reliant on menin working properly. These are leukemia cells with a change in the DNA, i.e. a mutation in the NPM1 or KMT2A gene.

Trial Details

NCT ID
NCT06652438
Phase
PHASE3
Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Revumenib
  • Placebo
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Fairway, Kansas, United States|39.02223,-94.6319

Key Eligibility Criteria

  • In order to be eligible to participate in this study, a patient must meet all of the following criteria:
  • Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. ≥ 10% blas…
  • OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). KMT2A partia…
  • Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173) and EVOLVE-2 (HO177) are open for inclusion at your site, then patients c…

For full eligibility, visit ClinicalTrials.gov.

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