drugset / Trial / NCT06313437

Revumenib in Combination With 7+3 + Midostaurin in AML

NCT06313437

Non-randomizedSequentialOpen-labelTreatment

Summary

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)

Timeline

Start
2024-12-06
Primary completion
2027-03-02
Completion
2028-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Revumenib Small molecule 25 mg Oral
Subject Revumenib Small molecule 113 mg Oral
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous
Background Midostaurin Small molecule Oral