A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Myeloid Leukemia
In brief
The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
Key facts
- Study ID
- NCT02997202
- Run by
- Astellas Pharma Global Development, Inc.
- People needed
- 356
- Starts
- 2017-08-16
- Expected to finish
- 2023-05-09
- Last updated by the study team
- 2025-01-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
- Virginia G Piper Cancer Center — Scottsdale, Arizona, United States
- University of California San Francisco — San Francisco, California, United States
- Stanford University — Stanford, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- University of Florida — Gainesville, Florida, United States
- University of Miami — Miami, Florida, United States
- H. Lee Moffitt Cancer Center — Tampa, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Northside — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Indiana Blood and Marrow Transplant — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University of Maryland Medical Systems — Baltimore, Maryland, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- University of Massachusetts — Worcester, Massachusetts, United States
- Karmanos Cancer Center — Detroit, Michigan, United States
- University of Minnesota School of Medicine — Minneapolis, Minnesota, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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