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Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
NCT03836209 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Midostaurin
- DRUG Gilteritinib
Study Locations (20)
California
- University of California, San Francisco-Fresno (University Oncology Associates) — Clovis
- UCLA — Los Angeles
- Kaiser Permanente Oakland — Oakland
- UC Irvine Health — Orange
- Kaiser Permanente Roseville — Roseville
- Kaiser Permanente Santa Clara — Santa Clara
Illinois
- University of Chicago Medical Center — Chicago
- Northwestern University Feinberg School of Medicine — Chicago
Massachusetts
- Tufts Medical Center — Boston
- Massachusetts General Hospital — Boston
Arizona
- HonorHealth Research Institute — Scottsdale
Florida
- Mayo Clinic- Jacksonville, FL — Jacksonville
Georgia
- Augusta University Medical Center — Augusta
Indiana
- Franciscan Health Indianapolis — Indianapolis
Kentucky
- University of Kentucky Markey Cancer Center — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2019-12-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03836209
The ClinicalTrials.gov registry entry for NCT03836209 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PrECOG, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions — of which Cytarabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03836209 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03836209 about?
NCT03836209 is a clinical study titled "Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia". 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-dos...
What is the current status of trial NCT03836209?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2019-12-06. Estimated completion is 2026-12.
What conditions does trial NCT03836209 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03836209?
The interventions under investigation include: Cytarabine (DRUG), Daunorubicin (DRUG), Midostaurin (DRUG), Gilteritinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03836209?
This trial is sponsored by PrECOG, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03836209 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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