Trial · NCT07012044
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
NCT07012044, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07012044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07012044
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT07012044
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 47 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Acute Myeloid Leukemia Post Cytotoxic Therapy, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Interventions
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine, Decitabine and Cedazuridine, Filgrastim, Imaging Procedure, Lumbar Puncture
- First posted
- 2025-06-10
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose of ASTX727 | Up to completion of cycle 2 (cycle length=28 days) | Defined as maximum dose at which fewer than one-third of patients experience dose limiting toxicity. |
| Primary | Incidence of adverse events of ASTX727 | Up to 2 years | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Primary | Area under the concentration by time curve of ASTX727 | Up to 28 days | Median area under the concentration over time curve assessed at 1 and 3 hours post dose in cycle 1 stratified by dose level. |
| Primary | Half life of ASTX727 | Up to 28 days | Median half-life of ASTX727 stratified by dose level assessed at 1 and 3 hours post dose in cycle 1 stratified by dose level. |
| Primary | Clearance of ASTX727 | Up to 28 days | Median clearance of ASTX727 assessed at 1 and 3 hours post dose in cycle 1 stratified by dose level. |
| Secondary | Incidence of graft versus host disease of ASTX727 | Up to 2 years | Frequency of graft versus host disease stratified by dose level. |
| Secondary | Severity of graft versus host disease of ASTX727 | Up to 2 years | Frequency of graft versus host disease severity score stratified by dose level. |
| Secondary | Incidence of graft rejection of ASTX727 | Up to 2 years | Frequency of graft rejection stratified by dose level. |
| Secondary | Severity of graft rejection of ASTX727 | Up to 2 years | Frequency of graft rejection severity score by dose level. |
| Secondary | Event free survival of ASTX727 | At 1 year | Median time to event stratified by dose level. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA228823 | Pediatric Early Phase Clinical Trials Network (PEP-CTN) Transfer Application | FOX, ELIZABETH | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2018 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07012044
GET https://conductscience.org/api/trials/v1/NCT07012044/registered