Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
NCT04203316 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial studies the side effects of enasidenib and sees how well it works in treating pediatric patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for leukemia cell growth.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Enasidenib Mesylate
- DRUG Enasidenib
Study Locations (20)
Colorado
- Children's Hospital Colorado — Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
- Children's National Medical Center — Washington D.C.
Florida
- UF Health Cancer Institute - Gainesville — Gainesville
- Nicklaus Children's Hospital — Miami
New York
- State University of New York Upstate Medical University — Syracuse
- Montefiore Medical Center - Moses Campus — The Bronx
Alabama
- Children's Hospital of Alabama — Birmingham
Arkansas
- Arkansas Children's Hospital — Little Rock
Delaware
- Alfred I duPont Hospital for Children — Wilmington
Illinois
- Lurie Children's Hospital-Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2026-10-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04203316
The ClinicalTrials.gov registry entry for NCT04203316 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04203316 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Colorado, District of Columbia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04203316 about?
NCT04203316 is a clinical study titled "Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation". This phase II trial studies the side effects of enasidenib and sees how well it works in treating pediatric patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic cha...
What is the current status of trial NCT04203316?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2023-08-14. Estimated completion is 2026-10-03.
What conditions does trial NCT04203316 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04203316?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Enasidenib Mesylate (DRUG), Enasidenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04203316?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04203316 being conducted?
This trial has 20 study locations across Alabama, Arkansas, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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