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Study identifier: NCT06177067 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Refractory Acute Myeloid Leukemia · Relapsed Acute Myeloid Leukemia · Acute Leukemia of Ambiguous Lineage  ·  Sponsor: St. Jude Children's Research Hospital

PhasePhase 1
Planned participants24
Who can joinAll sexes, 1 Year to 30 Years
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Hiroto Inaba, MD, PhD  ·  888-226-4343  ·  referralinfo@stjude.org

Always discuss trial participation with your own doctor first.

Locations (10)

Rady Children's HospitalSan Diego, California, United StatesRecruiting
Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting
Children's Healthcare of AtlantaAtlanta, Georgia, United StatesRecruiting
Children's Mercy Hospital of Kansas CityKansas City, Missouri, United StatesRecruiting
Memorial Sloan- Kettering Cancer CenterNew York, New York, United StatesRecruiting
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio, United StatesRecruiting
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United StatesRecruiting
St. Jude Children's Research HospitalMemphis, Tennessee, United StatesRecruiting
UT Southwestern/Simmons Cancer CenterDallas, Texas, United StatesRecruiting
Cook Children's Medical CenterFort Worth, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06177067