RecruitingPhase IEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Rozpoznanie ostrą białaczką szpikową lub białaczką o niejasnym pochodzeniu, która nie poddała się co najmniej dwóm kursom chemioterapii lub nawróciła po osiągnięciu remisji
  • Obecność co najmniej 5% białych komórek nowotworowych w szpiku kostnym lub 1% w krwi
  • Wiek od 1 roku do 30 lat
  • Dobrze funkcjonująca wątroba, nerki i serce (określone parametrami medycznymi)
  • Co najmniej 14 dni od zakończenia poprzedniej chemioterapii (z pewnymi wyjątkami)
  • Liczba białych krwinek poniżej 25 000 komórek na mikroliter krwi
  • Posiadanie określonych zmian genetycznych w komórkach nowotworowych (KMT2A, NUP98, NPM1 lub inne)
  • Wystarczająco dobry ogólny stan zdrowia do tolerowania leczenia

Simplified criteria — AI translation

Trial details

Minimum age
1 Year
Maximum age
30 Years
Last updated (source)
August 3, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (10)

Rady Children's Hospital

San Diego, United States

Children's Hospital Colorado

Aurora, United States

Children's Healthcare of Atlanta

Atlanta, United States

Children's Mercy Hospital of Kansas City

Kansas City, United States

Memorial Sloan- Kettering Cancer Center

New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, United States

Children's Hospital of Philadelphia

Philadelphia, United States

St. Jude Children's Research Hospital

Memphis, United States

UT Southwestern/Simmons Cancer Center

Dallas, United States

Cook Children's Medical Center

Fort Worth, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/4/2026.

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