Spots Global Cancer Trial Database for Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
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Trial Identification
Brief Title: Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
Official Title: 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
Study ID: NCT04203316
Study Description
Brief Summary: This trial studies the side effects of enasidenib and to see how well it works in treating 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 cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety of treatment with enasidenib mesylate (enasidenib) administered at continuous daily oral dosing for a 28-day cycle up to 12 cycles in pediatric patients with IDH2-mutant relapsed/refractory (R/R)-acute myeloid leukemia (AML). II. To characterize the plasma pharmacokinetic (PK) profile of enasidenib in pediatric patients with IDH2-mutant R/R-AML. SECONDARY OBJECTIVES: I. To investigate the pharmacodynamic (PD) relationship of oncogenic metabolite 2-hydroxyglutarate (2-HG) to enasidenib treatment in pediatric patients with IDH2-mutant R/R-AML. II. To describe the clinical activity of enasidenib in pediatric patients with IDH2-mutant R/R-AML. OUTLINE: Patients receive enasidenib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and/or biopsy and collection of blood on study. After completion of study treatment, patients are followed up at 30 days, then periodically up to 1 year.
Keywords
Eligibility
Minimum Age: 24 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Children's Hospital of San Antonio, San Antonio, Texas, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Contact Details
Name: Sara Zarnegar-Lumley
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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