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RECRUITING
NCT06177067
PHASE1

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective * To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives * Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).

Official title: A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

1 Year - 30 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-04-19

Completion Date

2027-04

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Revumenib

Given by mouth (capsule or liquid solution) or liquid solution by Nasogastric tube (NG) or Gastrostomy tube (G-tube)

DRUG

Venetoclax

Given by mouth (tablet) or by NG or G-tube

DRUG

Azacitidine

Given intravenously (IV) infusion

DRUG

intrathecal (IT) chemotherapy

Given intrathecal (IT)

DRUG

Cytarabine

Given intrathecal (IT) as part of intrathecal (IT) chemotherapy.

DRUG

Methotrexate

Given intrathecal (IT) as part of intrathecal (IT) chemotherapy.

Locations (10)

Rady Children's Hospital

San Diego, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Mercy Hospital of Kansas City

Kansas City, Missouri, United States

Memorial Sloan- Kettering Cancer Center

New York, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

UT Southwestern/Simmons Cancer Center

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States