RecruitingPhase 1NCT06222580

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Safety and Efficacy of Dual Menin and FLT3 Inhibition in Patients With Relapsed/Refractory FLT3- Mutated Acute Myeloid Leukemia Containing a Concurrent MLL-Rearrangement or NPM1 Mutation: A Phase I (Ph I) Study of SNDX-5613 + Gilteritinib


Sponsor

Uma Borate

Enrollment

30 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — SNDX-5613 and gilteritinib — in adults with relapsed or treatment-resistant AML (acute myeloid leukemia) that has specific genetic mutations (FLT3 mutation plus either an NPM1 mutation or MLL gene rearrangement). **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with AML that has relapsed or stopped responding to treatment - Your leukemia has both a FLT3 mutation (ITD or TKD type) AND an NPM1 mutation or MLL gene rearrangement - You are considered too unwell for intensive chemotherapy - Your heart, liver, and kidney function are adequate - You are able to swallow oral medications **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) - Your leukemia is only found outside the bone marrow (extramedullary) - You have a second active cancer requiring treatment - You are pregnant or breastfeeding - You have uncontrolled heart problems or a history of serious heart rhythm disorders - You have active hepatitis B, C, or HIV with detectable virus 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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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

DRUGGilteritinib

Given PO

DRUGRevumenib

Given PO

PROCEDUREEchocardiography Test

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA


Locations(3)

UNC Hospitals, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06222580


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