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NCT03164057 · ClinicalTrials.gov registry record · Phase 2
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
- 10
- Study locations
NCT03164057: Active Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by St. Jude Children's Research Hospital.
NCT03164057 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 206 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% higher). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03164057, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
Patients will be monitored for grade 4-5 non-hematologic toxic events during these two courses of chemotherapy. Tolerating a course is defined as completing the course without experiencing death or a grade 4 non-hematologic toxicity.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Decitabine
- DRUG Etoposide
- DRUG Cytarabine
- DRUG Daunorubicin
Study Locations (10)
California
- Children's Hospital of Central California - Madera
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital and Health Center - San Diego
Illinois
- University of Chicago Children's Hospital (Comer) - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Children's Hospital of Michigan - Detroit
South Dakota
- Sanford Children's Specialty Clinic - Sioux Falls
Tennessee
- St. Jude Children's Research Hospital - Memphis
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2017-06-15 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What the registry record for NCT03164057 still lists
NCT03164057 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (79% higher).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Azacitidine is the first listed.
NCT03164057 lists 10 locations in 7 states (California, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03164057 about?
NCT03164057 is a clinical study titled "A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia". 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 survi...
What is the current status of trial NCT03164057?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2017-06-15. Estimated completion is 2027-06.
What conditions does trial NCT03164057 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT03164057?
The interventions under investigation include: Azacitidine (DRUG), Decitabine (DRUG), Etoposide (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG).
Who is sponsoring clinical trial NCT03164057?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03164057 being conducted?
This trial has 10 study locations across California, Illinois, Massachusetts, Michigan, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03164057's enrollment target sits among peer trials
206 45th of 306 higher than 261 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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