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
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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)
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- Last Updated12/24/2025
- Study HIC#2000040630