drugset / Trial / NCT06313437
Revumenib in Combination With 7+3 + Midostaurin in AML
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |