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Myeloid and Monocytic Leukemia, Phase I

A Phase I Trial of Revumenib in Combination With 7+3 (7 Days of Cytarabine and 3 Days of Daunorubicin) + Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AML

What is the purpose of this trial?

This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).

The names of the study drugs involved in this study are:

  • Revumenib (SNDX-5613) (a type of menin inhibitor)
  • Midostaurin (a type of multi-kinase including FLT3 inhibitor)
  • Cytarabine (a type of antineoplastic agent)
  • Daunorubicin (a type of antineoplastic agent)

Contact Information

For more information about this study, including how to volunteer, contact Farah Fasihuddin

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  • Last Updated
    12/24/2025
  • Study HIC
    #2000040630