Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation (NCT04203316)

🧪 Interventions in This Study

• Enasidenib (DRUG)
• Enasidenib Mesylate (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients must be \>= 24 months and \< 21 years of age at the time of study enrollment
2. Patient must have AML with an IDH2 mutation identified from a peripheral blood or bone marrow sample at the time of diagnosis and/or relapsed/refractory disease
3. Patient must have bone marrow assessment (aspiration or biopsy) with \> 5% leukemic blasts by morphology and/or flow cytometry in at least one of the following clinical scenarios:
4. Second or greater relapse after chemotherapy or hematopoietic stem cell transplant (HSCT)
5. Refractory after \>= 2 attempts at induction therapy
6. Relapsed patients
7. Must not have received prior re-induction therapy for this relapse
8. Each block of chemotherapy (i.e., cytarabine, daunorubicin and etoposide \[ADE\], cytarabine and mitoxantrone \[MA\]) is a separate re-induction attempt
9. Donor lymphocyte infusion (DLI) is considered a re-induction attempt
10. Refractory patients
11. Each attempt at induction therapy may include up to two chemotherapy courses
12. Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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.
• 💵 Compensation indicated: Should a patient be found to have CNS2 or CNS3 status by CSF prior to eligibility screening, patient may receive intrathecal chemotherapy \> 72 hours prior to starting study drug.

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
• Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia — Houston, Texas
• A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia — Duarte, California
• Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm — Houston, Texas
• BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation — Duarte, California

Explore by condition: All Recurrent Acute Myeloid Leukemia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.