Current Research Studies

PEPN2413: A Phase 1 study of oral cedazuridine and decitabine combination (ASTX727, IND# 175393, NSC# 820631) and filgrastim as maintenance therapy post-hematopoietic stem cell transplant in children with high-risk acute myeloid leukemia

PEPN2413

  • Condition(s): Leukemia, other, Myeloid and Monocytic Leukemia
  • Phase: I
  • Clinicaltrials.gov ID: NCT07012044

What is the goal of the study?

This phase I trial tests the safety, side effects, and best dose of ASTX727 and filgrastim for the treatment of children with high risk acute myeloid leukemia that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory) who have undergone allogenic hematopoietic stem cell transplantation. ASTX727 is a combination of cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Filgrastim stimulates the production of neutrophils (a type of white blood cell) which can help to prevent infection. Giving ATSX727 and filgrastim may be safe and tolerable in treating children with high risk, recurrent or refractory acute myeloid leukemia who have undergone allogenic hematopoietic stem cell transplantation.

Who can participate in the study?

Please contact the study team listed below to learn more.

Study Team: