NCT06222580

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Uma Borate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the safety of revumenib (SNDX-5613) + gilteritinib. SECONDARY OBJECTIVES: I. To determine the preliminary efficacy of SNDX- 5613+ Gilteritinib. EXPLORATORY OBJECTIVES: I. To perform pharmacokinetic and pharmacodynamics assessments of the study drug combination. OUTLINE: This is a dose-escalation study. Patients receive SNDX-5613 orally (PO) twice per day (BID) and gilteritinib PO once per day (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan during screening, as well as bone marrow biopsy and aspiration and blood sample collection throughout the study. After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 2 years.

Conditions

• Acute Myeloid Leukemia With FLT3/ITD Mutation
• Acute Myeloid Leukemia With KMT2A Rearrangement
• Acute Myeloid Leukemia With NPM1 Mutation
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration and Biopsy	Undergo bone marrow aspiration and biopsy
DRUG	Gilteritinib	Given PO
DRUG	Revumenib	Given PO
PROCEDURE	Echocardiography Test	Undergo ECHO
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA

Timeline

• Start date: 2024-02-20
• Primary completion: 2027-01-31
• Completion: 2027-02-28
• First posted: 2024-01-24
• Last updated: 2026-03-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study