Drug or treatment

Gilteritinib clinical trials

• 14Clinical trials
• 8Countries

Newest trials

All recruiting trials (14)

• MRD‑guided maintenance after transplant: gilteritinib versus sorafenib

  This trial tests whether taking gilteritinib or sorafenib after an allogeneic stem cell transplant helps people aged 14–70 with FLT3‑ITD–positive AML who were MRD‑positive before transplant.

  Recruiting at 2 sites Phase 3 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu and 1 other locations · NCT07463651

• Gilteritinib with Venetoclax and Azacitidine, then High‑Dose Cytarabine and Gilteritinib Maintenance for Newly Diagnosed FLT3‑ITD AML

  This approach tests whether combining gilteritinib with venetoclax and azacitidine for induction, followed by DeepScan‑guided high‑dose cytarabine consolidation and gilteritinib maintenance, can produce deep remissions and allow fit adults with newly diagnosed FLT3‑ITD AML to avoid transplant.

  Recruiting Phase 2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07259707

• Gilteritinib for adults with advanced ALK-positive non-small cell lung cancer

  This phase 1 trial tests whether gilteritinib can help adults with advanced ALK-positive non-small cell lung cancer who have progressed after prior ALK inhibitor treatment.

  Recruiting at 16 sites Phase 1 Astellas Pharma Inc · Fullerton, California and 16 other locations · NCT07140016

• Combining Gilteritinib with Venetoclax and Azacitidine for AML Patients with FLT3 Mutations

  This study is testing if adding Gilteritinib to the standard treatments of Venetoclax and Azacitidine can help newly diagnosed AML patients with FLT3 mutations who can't have intensive chemotherapy.

  Recruiting Phase 2 Technische Universität Dresden · Dresden · NCT06696183

• Efficacy of a triple drug regimen for newly diagnosed AML patients with FLT3 mutation

  This study is testing a new combination of three drugs to see if it helps newly diagnosed acute myeloid leukemia patients with FLT3 mutations respond better to treatment.

  Recruiting Phase 1/2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06561880

• Combining Gilteritinib and Momelotinib for FLT3-Mutated Acute Myeloid Leukemia

  This study is testing a new combination of two drugs, gilteritinib and momelotinib, to see if they can safely help adults with a specific type of leukemia that hasn't responded to other treatments.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT06235801

• Using gilteritinib to treat advanced ALK positive lung cancer

  This study is testing if gilteritinib can safely help people with advanced ALK positive lung cancer who haven't had success with other treatments.

  Recruiting Phase 1 University of Michigan Rogel Cancer Center · Los Angeles, California and 2 other locations · NCT06225427

• Combination treatment for relapsed or refractory acute myeloid leukemia with specific mutations

  This study is testing a new combination of two drugs for people with relapsed or hard-to-treat acute myeloid leukemia that has specific gene mutations to see if it helps them feel better.

  Recruiting at 4 sites Phase 1 Ohio State University Comprehensive Cancer Center · Chapel Hill, North Carolina and 3 other locations · NCT06222580

• Combining oral azacitidine with gilteritinib for treating relapsed FLT3-mutated acute myeloid leukemia

  This study is testing if adding an oral medication called azacitidine to gilteritinib can help adults with relapsed FLT3-mutated acute myeloid leukemia feel better and live longer.

  Recruiting at 3 sites Phase 2 French Innovative Leukemia Organisation · Amiens and 19 other locations · NCT06022003

• Combining Vyxeos and Gilteritinib for FLT3-Mutated Acute Myeloid Leukemia

  This study is testing if combining two drugs, vyxeos and gilteritinib, can help people with FLT3-mutated acute myeloid leukemia who have not responded to previous treatments.

  Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT05024552

• Using decitabine alone or with other drugs to maintain remission in acute myeloid leukemia

  This study is testing if the drug decitabine, alone or with other medications, can help keep people with acute myeloid leukemia in remission and improve their chances of staying healthy.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT05010772

• Combination treatment for FLT3-mutated acute myeloid leukemia and high-risk myelodysplastic syndrome

  This study is testing a new combination of three drugs to see if it can help people with FLT3-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome feel better and live longer.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT05010122

• Comparing chemotherapy options for newly diagnosed acute myeloid leukemia

  This study is testing whether a new combination of treatments is better than standard chemotherapy for children and young adults with newly diagnosed acute myeloid leukemia.

  Recruiting at 188 sites Phase 3 Children's Oncology Group · Birmingham, Alabama and 205 other locations · NCT04293562

• Combining azacitidine, venetoclax, and gilteritinib for treating FLT3-mutated blood cancers

  This study is testing a new combination of three medications to see if they can help people with certain types of blood cancers that have a specific genetic mutation.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT04140487

Quick answers

How many clinical trials of Gilteritinib are recruiting right now?

14, as of November 12, 2026. We update this list each time we refresh our data from ClinicalTrials.gov.

Where are these trials running?

In 8 countries. The most sites are in United States (9 trials), China (3 trials), France (2 trials), Australia (1 trial), Canada (1 trial). Each study page lists its sites and which ones are recruiting.

What phases are they in?

Phase 1: 5, Phase 1/2: 4, Phase 2: 3, Phase 3: 2. Trials with no phase listed are usually device, behavioural or observational studies.

How do I join one?

Open a study, check the "Is this trial a fit for you?" section, then contact the study team listed on the page. They will ask a few screening questions. Asking is free and does not commit you to anything. Talk it over with your doctor first.

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