RecruitingPhase 1NCT06313437

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

Sponsor

Richard Stone, MD

Enrollment

22 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

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)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment for newly diagnosed acute myeloid leukemia (AML) — a fast-growing blood cancer. It adds a targeted drug called revumenib to the standard "7+3" chemotherapy regimen plus midostaurin, which specifically targets patients whose leukemia has certain genetic mutations. **You may be eligible if...** - You are between 18 and 74 years old - You have been newly diagnosed with AML and have not yet received treatment (except for a short course of hydroxyurea or brief ATRA for suspected APL) - Your leukemia has both FLT3 mutations (ITD or TKD) AND an NPM1 mutation - Your general health is good enough for intensive chemotherapy (ECOG 0–2) **You may NOT be eligible if...** - You have already received chemotherapy or other treatments for your AML (other than hydroxyurea) - You have had a prior allogeneic (donor) stem cell transplant - You lack the specific genetic mutations (FLT3 + NPM1) required for this study - Your organ function or overall health does not allow intensive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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