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A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia

Testing a new drug combination for children post-stem cell transplant.

Recruiting
21 years and younger
All
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is looking at how safe a new treatment is for kids with high-risk acute myeloid leukemia (AML), a type of blood cancer. The treatment uses a mix of drugs called ASTX727 (cedazuridine and decitabine) and filgrastim. Cedazuridine helps decitabine work better by stopping it from breaking down too fast in the body. Decitabine helps the body make normal blood cells and kills cancer cells. Filgrastim helps decitabine work even better.

In this study, kids will take these medicines after receiving a special type of blood cell transplant. The main goal is to find the highest safe dose of the medicines and understand any side effects. Kids will take ASTX727 by mouth for five days in a row and filgrastim for six days, repeated every 28 days for up to a year.

  • The study lasts up to 1 year with regular check-ups.
  • Participants must be 21 or younger and have had a specific type of blood transplant.
  • Frequent blood tests and check-ups are required throughout the study.
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Study details
    Acute Myeloid Leukemia Post Cytotoxic Therapy
    Recurrent Acute Myeloid Leukemia
    Refractory Acute Myeloid Leukemia

NCT07012044

National Cancer Institute (NCI)

17 October 2026

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