A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Children, Adolescents, and Young Adults With Acute Myeloid Leukemia

Full Title

A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax and in Pediatric and Young Adult Patients with Refractory or Relapsed Acute Myeloid Leukemia (RAVAML)

Purpose

Researchers are assessing two different doses of revumenib to give with azacitidine and venetoclax in young people with leukemia. This study includes children, teens, and young adults with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that came back or keeps progressing after treatment.

Revumenib blocks a protein called menin that leukemia cells need to grow and mature. Venetoclax blocks BCL-2, a protein that helps cancer cells survive and resist the effects of cancer treatments. By blocking menin, revumenib will make leukemia cells mature and become normal cells. By blocking BCL-2, venetoclax may cause the death of cancer cells or make them more sensitive to other treatments. Revumenib and azacitidine are both taken orally (by mouth).

Azacitidine switches off another protein, leading to the turning on of genes that stop cancer cells from growing and dividing. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You or your child must:

  • Have AML or ALAL that came back or keeps progressing after treatment.
  • Be age 1 year to 30 years.

Contact

For more information and to see if you or your child can join this study, please call 833-MSK-KIDS.

Protocol

24-368

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06177067