A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Trial Details

NCT ID
NCT06852222
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Bleximenib
  • Venetoclax (VEN)
  • Azacitidine (AZA)
  • Placebo
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Duarte, California, United States|34.13945,-117.97729
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Be 18 years of age or older at the time of informed consent
  • Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) wi…
  • Ineligible for intensive chemotherapy based on the following criteria: a) \>= 75 years of age and ineligible per physician's discretion, with Easte…
  • Participants must have adequate hepatic and renal function

For full eligibility, visit ClinicalTrials.gov.

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