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

Recruiting now · Phase 1

Conditions studied: Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Acute Leukemia of Ambiguous Lineage

In brief

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).

Key facts

Study ID

NCT06177067

Run by

St. Jude Children's Research Hospital

People needed

24

Starts

2024-04-19

Expected to finish

2027-04-01

Last updated by the study team

2026-08-03

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who are pregnant or breastfeeding are not eligible.
• Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.
• Patients with uncontrolled infection are not eligible. Patients with infections that are controlled on concurrent anti-microbial agents are eligible.

Where it is running

• Rady Children's Hospital — San Diego, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Children's Mercy Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• Memorial Sloan- Kettering Cancer Center — New York, New York, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
• UT Southwestern/Simmons Cancer Center — Dallas, Texas, United States (enrolling)
• Cook Children's Medical Center — Fort Worth, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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