Treatment
Gilteritinib clinical trials
We’re tracking 25 recruiting studies that include Gilteritinib, each written for real people, not researchers, below.
Recruiting studies
- NCT07140016RecruitingPhase 1
Study of gilteritinib for advanced ALK-positive lung cancer
This trial tests an oral drug called gilteritinib for people with advanced ALK-positive non-small cell lung cancer that has progressed after prior ALK inhibitor treatment. It aims to see if gilteritinib can help when other treatments have stopped working.
Fullerton, CaliforniaAges 18 years+ - NCT05024552RecruitingPhase 1
Vyxeos plus gilteritinib for certain relapsed AML
This Phase 1 trial studies whether combining Vyxeos (a chemotherapy) with gilteritinib (a targeted drug) can treat AML that has come back or hasn’t responded well, specifically AML with certain FLT3 mutations. If it works, it could improve chances of controlling the leukemia.
Tampa, FloridaAges 18 years+ - NCT03013998RecruitingPhase 1/Phase 2
Biomarker-guided treatment study for older adults with AML
This trial studies whether choosing treatment based on lab test “biomarkers” (specific genetic or blood markers) can help people with acute myeloid leukemia (AML). It focuses on adults who are not good candidates for the most intensive chemotherapy, and it uses different sub-studies for different AML types.
Phoenix, ArizonaAges 18 years+ - NCT04140487RecruitingPhase 1/Phase 2
Study drugs for certain FLT3-mutated blood cancers that have returned
This trial tests a combination of three medicines—azacitidine, venetoclax, and gilteritinib—in people with specific gene changes (FLT3 mutations) in leukemia and related bone marrow diseases that have come back or are hard to treat. The goal is to see if this drug combination can control the disease and improve outcomes.
Houston, TexasAges 18 years+ - NCT04293562RecruitingPhase 3
Testing targeted drugs plus chemo for newly diagnosed AML
This study compares standard chemotherapy to chemotherapy plus CPX-351 and/or gilteritinib in children and young adults newly diagnosed with AML. It aims to see whether adding these targeted treatments improves outcomes, especially for certain gene changes like FLT3.
Birmingham, AlabamaAges Up to 21 years - NCT05010122RecruitingPhase 1/Phase 2
Testing venetoclax and gilteritinib with ASTX727 for FLT3 leukemia
This Phase 1/2 trial tests a combination of medicines (ASTX727, venetoclax, and gilteritinib) for adults with FLT3-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). It aims to see how well the treatment works and how safe it is for people whose disease has come back, is not responding, or (for some) is newly diagnosed.
Houston, TexasAges 18 years+ - NCT05010772RecruitingPhase 1
Maintenance treatment study for AML in remission
This Phase 1 trial tests whether continuing decitabine alone or with other targeted drugs can help prevent AML from coming back after you reach remission. It’s designed to study safety and how well these maintenance options work for people who are not immediately able to get a stem cell transplant.
Houston, TexasAges 18 years+ - NCT05756777RecruitingPhase 1
Gilteritinib plus other IDH medicine for relapsed AML
This Phase 1 study tests how well gilteritinib works when combined with either ivosidenib or enasidenib in adults with relapsed or refractory acute myeloid leukemia (AML). It targets specific genetic changes in the leukemia and may help shrink or control the cancer when standard options haven’t worked.
Basking Ridge, New JerseyAges 18 years+ - NCT06222580RecruitingPhase 1
Combination of two targeted drugs for resistant FLT3-mutated AML
This trial tests a combination of two targeted drugs, SNDX-5613 and gilteritinib, for people whose AML has come back or hasn't responded to treatment. It is for those with an FLT3 gene mutation plus another specific genetic change like NPM1 or MLL. The study aims to see if this two-drug approach works better when used together.
Chapel Hill, North CarolinaAges 18 years+ - NCT06225427RecruitingPhase 1
Gilteritinib for advanced ALK-positive lung cancer
This trial tests a drug called gilteritinib for people with a specific genetic type of lung cancer (ALK-positive) that has spread and has been treated before. You may be eligible if you have already tried at least one targeted therapy, and your cancer is still growing.
Los Angeles, CaliforniaAges 18 years+ - NCT06696183RecruitingPhase 2
Gilteritinib with venetoclax and azacitidine for FLT3-positive AML
This trial tests adding a targeted drug called gilteritinib to a standard two-drug combination (venetoclax and azacitidine) for people with a specific genetic change (FLT3 mutation) in their acute myeloid leukemia (AML). The goal is to see if the three drugs together work better than the two alone, for patients who cannot tolerate strong chemotherapy.
DresdenAges 18 years+ - NCT07259707RecruitingPhase 2
Gilteritinib with chemotherapy for FLT3-ITD positive AML
This trial tests if adding the targeted drug gilteritinib to standard chemotherapy improves outcomes for adults with a specific type of AML (FLT3-ITD+). It's for newly diagnosed patients who can tolerate intensive treatment.
Hangzhou, ZhejiangAges 18–59 - NCT07463651RecruitingPhase 3
Gilteritini vs Sorafenib after transplant for FLT3-ITD AML
This trial tests two maintenance drugs (gilteritini and sorafenib) for people with FLT3-ITD positive AML after a stem cell transplant. It compares which drug better prevents relapse using a sensitive test for minimal residual disease (MRD).
Suzhou, JiangsuAges 14–70 - NCT06001788RecruitingPhase 1
Ziftomenib for relapsed or refractory acute myeloid leukemia
This trial tests a new drug combination called ziftomenib for people whose acute myeloid leukemia (AML) has come back or hasn't responded to treatment. Researchers will check how safe it is and what side effects happen.
Gilbert, ArizonaAges 18 years+ - NCT05564390RecruitingPhase 2
MyeloMATCH screening to match you to AML or MDS treatment
This study screens people with newly suspected acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) to see which treatment approach fits best—either a specific study treatment or standard care. It may help by directing you to the right option and by sharing your blood/bone marrow samples for research.
Birmingham, AlabamaAges 18 years+ - NCT07131059Recruiting
Study for MRD-positive AML in remission
This trial is for people with acute myeloid leukemia (AML) who are in remission but still have tiny traces of leukemia cells that can be found with sensitive tests (called MRD-positive). The study is testing a new treatment approach to try to get rid of those remaining cells and prevent the cancer from coming back.
Tianjin, Tianjin MunicipalityAges 14 years+ - NCT06265545Recruiting
Study for relapsed or hard-to-treat AML
This trial tests new treatment options for people whose acute myeloid leukemia (AML) has either not responded to standard therapy or returned. It aims to find better ways to help those who need new options.
TianjinAges Any age - NCT06561880RecruitingPhase 1/Phase 2
Three-drug combo for FLT3-mutated AML
This trial is testing a three-drug combination for people newly diagnosed with a type of AML that has a FLT3 mutation. The goal is to see if this treatment works better than standard care.
Tianjin, Tianjin MunicipalityAges 14 years+ - NCT07032727RecruitingPhase 2
Olutasidenib plus targeted therapy for relapsed IDH1-mutated myeloid cancers
This trial tests a combination of olutasidenib with other targeted drugs for people with certain blood cancers that have returned or not responded to treatment. It focuses on patients who have both an IDH1 mutation and a second activating mutation in specific signaling genes.
Houston, TexasAges 18 years+ - NCT06317649RecruitingPhase 2
Venetoclax and HMA for older adults with FLT3-mutated AML
This trial tests a combination of two drugs (venetoclax and a hypomethylating agent) plus a targeted FLT3 inhibitor for older or frail patients with a specific genetic change in their acute myeloid leukemia. The goal is to see if this treatment is safe and effective without using the strongest chemotherapy.
Birmingham, AlabamaAges 18 years+ - NCT07548710RecruitingPhase 2
SA plus X for newly diagnosed AML
This trial tests a combination of two drugs, SA and X, for people who have just been diagnosed with acute myeloid leukemia (AML) and have not yet received treatment (except hydroxyurea to lower white blood cells). The goal is to see if the combination works better than standard care.
Shanghai, Shanghai MunicipalityAges 18 years+ - NCT04988555RecruitingPhase 1/Phase 2
Study of an investigational drug for high-risk acute leukemia
This Phase 1/2 study tests enzomenib (DSP-5336) in people with relapsed or hard-to-treat acute leukemia (and, in some places, certain other blood cancers). The goal is to see how the drug works and how safe it is, especially for leukemia cases with specific genetic changes (KMT2A/MLL or NPM1).
Newport Beach, CaliforniaAges 12 years+ - NCT06022003RecruitingPhase 2
Azacitidine plus gilteritinib for FLT3-mutated AML
This trial tests whether adding an oral chemotherapy pill (azacitidine) to the targeted drug gilteritinib helps people whose FLT3-mutated AML came back or didn't respond after their first treatment. The goal is to see if the combination is more effective than gilteritinib alone.
AmiensAges 18 years+ - NCT06221683RecruitingPhase 2
Personalized induction therapy for children with AML based on genetics
This trial tests different induction therapy options based on the specific genetic subtype of a child’s AML and how the leukemia responds early on. The goal is to personalize treatment to improve outcomes and reduce side effects.
Hefei, AnhuiAges Up to 18 years
What Gilteritinib is being studied for
Conditions with recruiting Gilteritinib studies.
- Acute Myeloid Leukemia
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
- Leukemia, Myeloid, Acute
- Acute Myeloid Leukemia With FLT3/ITD Mutation
- AML, Adult
- Recurrent Chronic Myelomonocytic Leukemia
- Recurrent Myelodysplastic/Myeloproliferative Neoplasm
- Refractory Chronic Myelomonocytic Leukemia
- Refractory Myelodysplastic/Myeloproliferative Neoplasm
Common questions
- Are there clinical trials studying Gilteritinib?
- Yes. Clin2 currently lists 25 recruiting studies that include Gilteritinib, drawn from the U.S. registry and rewritten for real people so you can see what each is testing and who it's for.
- How do I know if I qualify for a Gilteritinib trial?
- Each study lists its own eligibility criteria — rules about condition, age, and prior treatments. On every Clin2 trial page we explain these in plain language and offer a short, optional pre-screen for a fit read. The study team makes the final decision.
- Is Gilteritinib an approved treatment?
- A drug being studied in a trial may be investigational (still being tested) or already approved and being studied for a new use. Each study page explains what phase it's in. Clin2 does not provide medical advice — talk with your doctor about whether Gilteritinib or a specific trial is right for you.
Related treatments
Clin2 helps you find and understand clinical trials and does not provide medical advice. Study data comes from ClinicalTrials.gov. A drug appearing here is being studied in a trial and may be investigational. Talk with your doctor about whether a specific treatment or trial is right for you.