Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07498465
PHASE1

A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

Summary

This phase I trial tests the safety, best dose, and effectiveness of revumenib given as maintenance therapy after standard hematopoietic stem cell transplant (HSCT) in patients with acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia. Revumenib binds to a protein called menin, which prevents menin from interacting with another protein called MLL. This results in an inhibition of the proliferation of leukemic cells with certain genetic alterations. Revumenib may inhibit the survival, growth, transformation and proliferation of certain kinds of leukemia cells. It is approved for the treatment of patients with certain types of acute leukemia, but it is not approved for maintenance therapy (treatment that aims to prevent cancer from coming back) after HSCT.

Official title: A Phase 1 Trial of the Menin Inhibitor SNDX-5613 (Revumenib) (NSC# 852942) for Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia

Key Details

Gender

All

Age Range

30 Days - 22 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2026-09-10

Completion Date

2028-11-12

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cytarabine

Given IT

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Methotrexate

Given IT

PROCEDURE

Radiologic Examination

Undergo radiologic assessment

DRUG

Revumenib

Given PO or via NG- or G-tube

DRUG

Therapeutic Hydrocortisone

Given IT