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Clinical trialNCT06177067RecruitingPhase 1Interventional

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

SponsorSt. Jude Children's Research HospitalEnrollment24Acute Leukemia of Ambiguous LineageRefractory Acute Myeloid LeukemiaRelapsed Acute Myeloid Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Rady Children'S Hospital

    San Diego, California, United States

    Dennis Kuo, MD
    Recruiting
  • Children'S Hospital Colorado

    Aurora, Colorado, United States

    Kelly Faulk, MD
    Recruiting
  • Children'S Healthcare of Atlanta

    Atlanta, Georgia, United States

    Himalee Sabnis, MD
    Recruiting
  • Children'S Mercy Hospital of Kansas City

    Kansas City, Missouri, United States

    Keith August, MD
    Recruiting
  • Memorial Sloan- Kettering Cancer Center

    New York, New York, United States

    Maria-Luisa Sulis, MD
    Recruiting
  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

    Lauren Pommert, MD
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Sarah Tasian, MD
    Recruiting
  • St. Jude Children'S Research Hospital

    Memphis, Tennessee, United States

    Hiroto Inaba, MD, PhD
    Recruiting
  • Ut Southwestern/simmons Cancer Center

    Dallas, Texas, United States

    Kathleen Ludwig, MD
    Recruiting
  • Cook Children'S Medical Center

    Fort Worth, Texas, United States

    Holly Pacenta, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Apr 2024
Primary completion
31 Oct 2026
Completion
30 Apr 2027
Last update posted
3 Aug 2026
Registered enrollment
24
Registry id
NCT06177067

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.