Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation (NCT04203316)
An Open-Label Feasibility Study to Assess the Safety and Pharmacokinetics of Enasidenib in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML) With an Isocitrate Dehydrogenase-2 (IDH2) Mutation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 24 Months to 21 Years
🧪 Interventions in This Study
📋 "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 (28 Sites)
Showing the first 25 of 28 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- Arkansas Children's Hospital — Little Rock, Arkansas
- Children's Hospital Colorado — Aurora, Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
- Alfred I duPont Hospital for Children — Wilmington, Delaware
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- Children's National Medical Center — Washington D.C., District of Columbia
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Nicklaus Children's Hospital — Miami, Florida
- Lurie Children's Hospital-Chicago — Chicago, Illinois
- Riley Hospital for Children — Indianapolis, Indiana
- Norton Children's Hospital — Louisville, Kentucky
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- C S Mott Children's Hospital — Ann Arbor, Michigan
- Children's Mercy Hospitals and Clinics — Kansas City, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- State University of New York Upstate Medical University — Syracuse, New York
- Montefiore Medical Center - Moses Campus — The Bronx, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania
- Saint Jude Children's Research Hospital — Memphis, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee
- UT Southwestern/Simmons Cancer Center-Dallas — Dallas, 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.
More studies in Recurrent Acute Myeloid Leukemia
- Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax — Duarte, California
- CPX-351 Plus Enasidenib for Relapsed AML — Los Angeles, California
- Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant — Houston, Texas
- Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia — Duarte, California
- Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia — Birmingham, Alabama
Explore by condition: All Recurrent Acute Myeloid Leukemia clinical trials
💡 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.