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

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 when taken by mouth, making it more available in the body so that decitabine will

Trial Details

NCT ID

NCT07012044

Phase

PHASE1

Sponsor

National Cancer Institute (NCI)

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Biospecimen Collection
Bone Marrow Aspiration
Bone Marrow Biopsy
Decitabine
Decitabine and Cedazuridine
Filgrastim

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
San Francisco, California, United States|37.77493,-122.41942
Aurora, Colorado, United States|39.72943,-104.83192
Atlanta, Georgia, United States|33.749,-84.38798
Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

STEP 0: Patient must be ≤ 21 years of age
PLEASE NOTE: Eligibility criteria to enroll onto Step 1 for the treatment trial is ≤ 21 years of age at the time of Step 1 enrollment. Please plan …
STEP 0: Patients with newly diagnosed high risk\* de novo AML, newly diagnosed therapy-related AML, relapsed, or refractory AML. in complete remiss…
Based on risk criteria adopted by the AAML1831 study

For full eligibility, visit ClinicalTrials.gov.

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