New drug gilteritinib takes on standard therapy in FLT3 leukemia trial
NCT ID NCT03836209
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether the oral drug gilteritinib works better than midostaurin for adults with a specific genetic subtype of acute myeloid leukemia (FLT3-mutated AML). All 181 participants also receive standard chemotherapy. The goal is to see which drug leads to more complete remissions without detectable leukemia cells. Gilteritinib is already approved for relapsed AML but is investigational for newly diagnosed patients.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Gilteritinib and midostaurin (oral drugs targeting FLT3 protein) plus standard chemotherapy (daunorubicin and cytarabine)
What this could lead to
If gilteritinib works better than midostaurin, it could become a new standard treatment for newly diagnosed FLT3-mutated AML, improving remission rates.
What could go wrong
This is a Phase 2 trial with only 181 participants, so results may not be definitive. Gilteritinib is not yet approved for newly diagnosed patients, and side effects from the drugs or chemotherapy could be serious.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Atlantic Health Systems/Morristown Medical Center
Morristown, New Jersey, 07962, United States
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Augusta University Medical Center
Augusta, Georgia, 30912, United States
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East Carolina University
Greenville, North Carolina, 27834, United States
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Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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Kaiser Permanente Oakland
Oakland, California, 94611, United States
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Kaiser Permanente Roseville
Roseville, California, 95661, United States
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Kaiser Permanente Santa Clara
Santa Clara, California, 94115, United States
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LDS Hospital
Salt Lake City, Utah, 84143, United States
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Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic- Jacksonville, FL
Jacksonville, Florida, 32224, United States
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Mayo Clinic- Rochester, MN
Rochester, Minnesota, 55905, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Mount Sinai
New York, New York, 10029, United States
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MultiCare
Spokane, Washington, 99218, United States
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Northwell Health
Lake Success, New York, 11042, United States
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
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Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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SUNY Upstate Medical University
Syracuse, New York, 13210, United States
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St. Joseph's Mercy Hospital
Ann Arbor, Michigan, 48106, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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UC Irvine Health
Orange, California, 92868, United States
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UCLA
Los Angeles, California, 90095, United States
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UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University of California, San Francisco-Fresno (University Oncology Associates)
Clovis, California, 93611, United States
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University of Chicago Medical Center
Chicago, Illinois, 60451, United States
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University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
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University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
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University of Nebraska Medical Center
Omaha, Nebraska, 68105, United States
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University of Oklahoma Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
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University of Rochester Medical Center
Rochester, New York, 14642, United States
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University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792, United States
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Vanderbilt University
Nashville, Tennessee, 37232, United States
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Weill Cornell Medicine New York Presbyterian Hospital
New York, New York, 10065, United States
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West Virginia University
Morgantown, West Virginia, 26506, United States