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NCT07012044 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT07012044: Recruiting Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT07012044 is a Phase 1 study that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07012044, a Phase 1 study, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Defined as maximum dose at which fewer than one-third of patients experience dose limiting toxicity.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Decitabine
- DRUG Decitabine and Cedazuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2026-06-09 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What NCT07012044 shows while recruiting
NCT07012044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07012044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07012044 about?
NCT07012044 is a clinical study titled "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 ...
What is the current status of trial NCT07012044?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2026-06-09. Estimated completion is 2027-03-31.
What interventions are being tested in trial NCT07012044?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine (DRUG), Decitabine and Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT07012044?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07012044's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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