RecruitingPhase 1NCT06177067

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

A Phase 1 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

Enrollment

24 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — revumenib, azacitidine, and venetoclax — for children and young adults with relapsed or refractory acute myeloid leukemia (AML) that carries specific genetic mutations (such as KMT2A or NUP98 rearrangements) that are targeted by revumenib. **You may be eligible if...** - You are a child or young adult with AML or a related leukemia that has relapsed (come back) or did not respond to at least two rounds of chemotherapy - Your leukemia carries one of the specific gene mutations targeted by this trial (KMT2A, NUP98, NPM1, or others listed in the protocol) - Your bone marrow has at least 5% leukemia cells confirmed - You have adequate organ function **You may NOT be eligible if...** - Your leukemia does not have one of the required genetic mutations - You do not have enough leukemia cells in the bone marrow to confirm relapse - Your organ function (liver, kidneys, heart) is too impaired for this treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRevumenib

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

DRUGVenetoclax

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

DRUGAzacitidine

Given intravenously (IV) infusion

DRUGintrathecal (IT) chemotherapy

Given intrathecal (IT)

DRUGCytarabine

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

DRUGMethotrexate

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06177067


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