A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT03164057)
A Phase II Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Central California — Madera, California
Age range: 29 Days to 21 Years
🧪 Interventions in This Study
- 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)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Children's Hospital of Central California — Madera, California
- Children's Hospital of Orange County — Orange, California
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California
- Rady Children's Hospital and Health Center — San Diego, California
- University of Chicago Children's Hospital (Comer) — Chicago, Illinois
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Children's Hospital of Michigan — Detroit, Michigan
- Sanford Children's Specialty Clinic — Sioux Falls, South Dakota
- St. Jude Children's Research Hospital — Memphis, Tennessee
- Cook Children's Medical Center — Fort Worth, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia — Burbank, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.