NCT06313437

Revumenib in Combination With 7+3 + Midostaurin in AML

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Richard Stone, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a single arm open label phase I trial of the menin inhibitor, revumenib, in combination with cytarabine and daunorubicin (7+3) chemotherapy and the multikinase inhibitor midostaurin for the frontline treatment of Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML). Investigators are trying to determine the highest dose of revumenib that can be given safely in combination with these chemotherapy drugs. Treatment consists of 1-2 cycles of so-called "induction treatment" (initial chemotherapy to induce a remission of the leukemia). This "induction treatment" consists of revumenib + 7+3 (7 days of cytarabine + 3 days of daunorubicin) chemotherapy + midostaurin. The U.S. Food and Drug Administration (FDA) has not approved the combination of revumenib, cytarabine, daunorubicin, and midostaurin as a treatment for AML. The research study procedures include screening for eligibility, study treatment visits, blood and urine tests, bone marrow biopsies, and electrocardiograms (ECGs). Participants will receive study treatment as long as there are no serious side effects and the disease does not progress. The trial will include up to 12 participants in dose finding phase and 10 additional participants in the dose expansion phase for a total participant number of 22 participants. Syndax Pharmaceuticals is supporting this research study by supply revumenib (SNDX-5613).

Conditions

• Acute Myeloid Leukemia
• AML, Adult
• AML With Gene Mutations
• AML
• Leukemia

Interventions

Type	Name	Description
DRUG	Revumenib	Menin inhibitor, 25 and 113 mg capsules, taken orally per protocol.
DRUG	Midostaurin	Kinase inhibitor, capsule taken orally per protocol.
DRUG	Cytarabine	Antineoplastic agent, via intravenous (into the vein) infusion per protocol.
DRUG	Daunorubicin	Antineoplastic agent, via intravenous (into the vein) infusion per protocol.

Timeline

• Start date: 2024-12-06
• Primary completion: 2027-03-02
• Completion: 2028-03-02
• First posted: 2024-03-15
• Last updated: 2026-03-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study