Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT03836209. 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
Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML.
Study identification
- NCT ID
- NCT03836209
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 181 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- 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
- Dec 6, 2019 (Actual)
- Primary completion
- Oct 17, 2023 (Actual)
- Completion
- Jun 30, 2026 (Actual)
- Last update posted
- Jul 23, 2026
2019 – 2026
United States locations
- U.S. sites
- 44
- U.S. states
- 24
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| University of California, San Francisco-Fresno (University Oncology Associates) | Clovis | California | 93611 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Kaiser Permanente Oakland | Oakland | California | 94611 | — |
| UC Irvine Health | Orange | California | 92868 | — |
| Kaiser Permanente Roseville | Roseville | California | 95661 | — |
| Kaiser Permanente Santa Clara | Santa Clara | California | 94115 | — |
| Mayo Clinic- Jacksonville, FL | Jacksonville | Florida | 32224 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60451 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| St. Joseph's Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| Mayo Clinic- Rochester, MN | Rochester | Minnesota | 55905 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | — |
| Atlantic Health Systems/Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Weill Cornell Medicine New York Presbyterian Hospital | New York | New York | 10065 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| University of Oklahoma Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| LDS Hospital | Salt Lake City | Utah | 84143 | — |
| MultiCare | Spokane | Washington | 99218 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center | Marshfield | Wisconsin | 54449 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03836209, 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 Jul 23, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03836209 live on ClinicalTrials.gov.