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)
Public ClinicalTrials.gov record NCT02997202. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02997202
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 356 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2017 (Actual)
- Primary completion
- Jan 7, 2023 (Actual)
- Completion
- May 9, 2023 (Actual)
- Last update posted
- Jan 17, 2025
2017 – 2023
United States locations
- U.S. sites
- 46
- U.S. states
- 26
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| Virginia G Piper Cancer Center | Scottsdale | Arizona | 85258 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Stanford University | Stanford | California | 94305 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami | Miami | Florida | 33136 | — |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northside | Atlanta | Georgia | 30342 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Indiana Blood and Marrow Transplant | Indianapolis | Indiana | 46237 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7233 | — |
| University of Maryland Medical Systems | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Massachusetts | Worcester | Massachusetts | 01655 | — |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | — |
| University of Minnesota School of Medicine | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Memorial Sloan Kettering | New York | New York | 10065 | — |
| Weill Cornell Medical Center | New York | New York | 10065 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University, The | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84143 | — |
| Intermountain BMT | Salt Lake City | Utah | 84143 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506-9214 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 72 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02997202, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 17, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02997202 live on ClinicalTrials.gov.