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