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Study identifier: NCT07012044 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Acute Myeloid Leukemia Post Cytotoxic Therapy · Recurrent Acute Myeloid Leukemia · Refractory Acute Myeloid Leukemia  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants47
Who can joinAll sexes, N/A to 21 Years
Healthy volunteersNo

About this 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.

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

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Contact details are listed per location below or on the registry record.

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Locations (8)

Children's Hospital of AlabamaBirmingham, Alabama, United StatesRecruiting
Riley Hospital for ChildrenIndianapolis, Indiana, United StatesRecruiting
C S Mott Children's HospitalAnn Arbor, Michigan, United StatesRecruiting
University of Minnesota/Masonic Cancer CenterMinneapolis, Minnesota, United StatesRecruiting
Memorial Sloan Kettering Cancer CenterNew York, New York, United StatesRecruiting
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United StatesRecruiting
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania, United StatesRecruiting
Saint Jude Children's Research HospitalMemphis, Tennessee, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07012044