A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT03164057. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The overall aim of this study is to determine if epigenetic priming with a DNA methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries evidence of a clinical efficacy signal as determined by minimal residual disease (MRD), event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as well as total reduction in DNA methylation and outcome assessments will be done to simultaneously obtain preliminary biological and clinical data for each DMTi in parallel. PRIMARY OBJECTIVES: * Evaluate the tolerability of five days of epigenetic priming with azacitidine and decitabine as a single agent DMTi prior to standard AML chemotherapy blocks. * Evaluate the change in genome-wide methylation burden induced by five days of epigenetic priming and the association of post-priming genome-wide methylation burden with event-free survival among pediatric AML patients. SECONDARY OBJECTIVES * Describe minimal residual disease levels following Induction I chemotherapy in patients that receive DMTi. * Estimate the event-free survival and overall survival of patients receiving a DMTi prior to chemotherapy courses.
Study identification
- NCT ID
- NCT03164057
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 206 participants
Conditions and interventions
Conditions
Interventions
- Azacitidine Drug
- Decitabine Drug
- Cytarabine Drug
- Daunorubicin Drug
- Etoposide Drug
- ITMHA Combination Product
- Idarubicin Drug
- Fludarabine Drug
- Mitoxantrone Drug
- Erwinia asparaginase Drug
- Sorafenib Drug
- G-CSF Drug
- Dexrazoxane Drug
- Stem Cell Transplant Biological
- Asparaginase Erwinia Chrysanthemi, Recombinant-Rywn Drug
Drug · Combination Product · Biological
Eligibility (public fields only)
- Age range
- 29 Days to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 15, 2017 (Actual)
- Primary completion
- Sep 20, 2025 (Actual)
- Completion
- Jun 2027 (Estimated)
- Last update posted
- Apr 23, 2026
2017 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Central California | Madera | California | 93636 | — |
| Children's Hospital of Orange County | Orange | California | 92968 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Rady Children's Hospital and Health Center | San Diego | California | 92123 | — |
| University of Chicago Children's Hospital (Comer) | Chicago | Illinois | 60637 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Sanford Children's Specialty Clinic | Sioux Falls | South Dakota | 57117 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03164057, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03164057 live on ClinicalTrials.gov.