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

ClinicalTrials.gov ID: NCT06177067

Public ClinicalTrials.gov record NCT06177067. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT06177067
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: St. Jude Children's Research Hospital; Other
Enrollment: 24 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 1 Year to 30 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 18, 2024
Primary completion: Sep 30, 2026
Completion: Mar 31, 2027
Last update posted: Aug 2, 2026

2024 – 2027

United States locations

U.S. sites: 10
U.S. states: 9
U.S. cities: 10

Facility	City	State	ZIP	Site status
Rady Children's Hospital	San Diego	California	92132	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	30329	Recruiting
Children's Mercy Hospital of Kansas City	Kansas City	Missouri	64108	Recruiting
Memorial Sloan- Kettering Cancer Center	New York	New York	10065	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
St. Jude Children's Research Hospital	Memphis	Tennessee	38105	Recruiting
UT Southwestern/Simmons Cancer Center	Dallas	Texas	75390	Recruiting
Cook Children's Medical Center	Fort Worth	Texas	76104	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06177067, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 2, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06177067 live on ClinicalTrials.gov.

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