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

NCT06177067 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-04

No results posted yet for this study

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).

Conditions

  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia
  • Acute Leukemia of Ambiguous Lineage

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.

Sponsors & Collaborators

Principal Investigators

  • Hiroto Inaba, MD, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2026-10-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06177067 on ClinicalTrials.gov