A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.

Trial Details

NCT ID
NCT04065399
Phase
PHASE1 / PHASE2
Sponsor
Syndax Pharmaceuticals
Status
RECRUITING
Cancer Type
Acute Lymphoblastic (ALL) Leukemia
Interventions
  • revumenib
  • cobicistat
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Participants must have active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the National Comp…
  • Arm A: Participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole.
  • Arm B: Participants receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis.
  • Arm C: Participants receiving revumenib in combination with cobicistat.

For full eligibility, visit ClinicalTrials.gov.

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