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
Hiroto Inaba, MD, PhD
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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