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Showing 1–24 of 44 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: ASP2215 Clear all
Completed Phase 3 Interventional Results available

A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy

NCT02752035
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Interventions
gilteritinib, azacitidine
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
183 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2024
U.S. locations
12
States / cities
Los Angeles, California • Orange, California • Chicago, Illinois + 7 more
Source: ClinicalTrials.gov public record
Updated Jul 13, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

NCT06235801
View directory record Official record
Conditions
Myeloid Leukemia
Interventions
Gilteritinib, Momelotinib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 1Phase 2 Interventional Results available

A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)

NCT03730012
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Interventions
gilteritinib, atezolizumab
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
12
States / cities
Los Angeles, California • Chicago, Illinois • Lexington, Kentucky + 7 more
Source: ClinicalTrials.gov public record
Updated Nov 28, 2024 · Synced Sep 3, 2026, 1:02 AM EDT
Active, not recruiting Phase 1Phase 2 Interventional

A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

NCT05520567
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia
Interventions
Gilteritinib, Venetoclax, Azacitidine
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
20
States / cities
Duarte, California • Irvine, California • Los Angeles, California + 14 more
Source: ClinicalTrials.gov public record
Updated Mar 3, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Recruiting Phase 1 Interventional

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

NCT05010772
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Decitabine and Cedazuridine, Enasidenib, Gilteritinib, Ivosidenib, Venetoclax
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Withdrawn Phase 1Phase 2 Interventional

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies

NCT05279859
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
ERAS-007, ERAS-601, Gilteritinib
Drug
Lead sponsor
Erasca, Inc.
Industry
Eligibility
18 Years to 99 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
4
States / cities
San Francisco, California • Dallas, Texas • Houston, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2022 · Synced Sep 3, 2026, 1:02 AM EDT
Approved For Marketing No phase listed Expanded access

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

NCT03070093
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Interventions
gilteritinib
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
U.S. locations
32
States / cities
Los Angeles, California • Aurora, Colorado • Pembroke Pines, Florida + 23 more
Source: ClinicalTrials.gov public record
Updated Apr 19, 2021 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 3 Interventional Results available

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

NCT02421939
View directory record Official record
Conditions
Leukemia, Acute Myeloid (AML)
Interventions
gilteritinib, LoDAC (Low Dose Cytarabine), Azacitidine, MEC (Mitoxantrone, Etoposide, Cytarabine), FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
371 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2025
U.S. locations
37
States / cities
Birmingham, Alabama • Los Angeles, California • Orange, California + 28 more
Source: ClinicalTrials.gov public record
Updated Dec 3, 2025 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 2 Interventional Results available

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

NCT03836209
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Gilteritinib, Midostaurin, Daunorubicin, Cytarabine
Drug
Lead sponsor
PrECOG, LLC.
Other
Eligibility
18 Years to 70 Years
Enrollment
181 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
44
States / cities
Scottsdale, Arizona • Clovis, California • Los Angeles, California + 36 more
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 1 Interventional

Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors

NCT02456883
View directory record Official record
Conditions
Advanced Solid Tumors, Pharmacokinetics of 14C-labeled Gilteritinib
Interventions
gilteritinib, 14C-labeled gilteritinib
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 4, 2024 · Synced Sep 3, 2026, 1:02 AM EDT
Recruiting Phase 2 Interventional

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

NCT02115295
View directory record Official record
Conditions
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Blasts 10 Percent or More of Peripheral Blood White Cells, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Acute Myeloid Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Interventions
Cladribine, Cytarabine, Gilteritinib, Idarubicin, Laboratory Biomarker Analysis, Midostaurin, Venetoclax
Drug · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years to 65 Years
Enrollment
508 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2030
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 19, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT04240002
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
Interventions
gilteritinib, fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF)
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
6 Months to 21 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 4, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Recruiting Phase 1 Interventional

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

NCT05024552
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation
Interventions
Gilteritinib, Vyxeos
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Dec 4, 2025 · Synced Sep 3, 2026, 1:02 AM EDT
Recruiting Phase 2 Interventional

Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

NCT07032727
View directory record Official record
Conditions
Targeted Therapy, IDH1-Mutated Malignancies, Mutations
Interventions
Olutasidenib, Cladribine (CLAD), Venetoclax, Gilteritinib, Ruxolitinib, Cytarabine
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT02014558
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Gilteritinib, Voriconazole, Midazolam, Cephalexin
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
265 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
23
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Duarte, California + 16 more
Source: ClinicalTrials.gov public record
Updated Dec 2, 2024 · Synced Sep 3, 2026, 1:02 AM EDT
Recruiting Phase 1 Interventional

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

NCT05756777
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML)
Interventions
Gilteritinib, Ivosidenib, Enasidenib
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 3 Interventional Results available

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

NCT02997202
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
gilteritinib, Placebo
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
356 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
46
States / cities
Birmingham, Alabama • Phoenix, Arizona • Scottsdale, Arizona + 35 more
Source: ClinicalTrials.gov public record
Updated Jan 16, 2025 · Synced Sep 3, 2026, 1:02 AM EDT
Suspended Phase 2 Interventional

A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

NCT05955261
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Venetoclax, Azacitidine, Cytarabine, Gemtuzumab Ozogamicin, Daunorubicin Hydrochloride, Fludarabine Phosphate, Idarubicin Hydrochloride, Mitoxantrone Hydrochloride, Etoposide, Gilteritinib
Drug
Lead sponsor
St. Jude Children's Research Hospital
Other
Eligibility
29 Days to 21 Years
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2034
U.S. locations
10
States / cities
Madera, California • Orange, California • San Diego, California + 7 more
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215

NCT02571816
View directory record Official record
Conditions
Hepatic Impairment, Healthy
Interventions
ASP2215
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2016
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 4, 2024 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

NCT02561455
View directory record Official record
Conditions
Advanced Solid Tumors, Acute Myeloid Leukemia
Interventions
Gilteritinib
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
7
States / cities
Phoenix, Arizona • Baltimore, Maryland • New York, New York + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 18, 2024 · Synced Sep 3, 2026, 1:02 AM EDT
Recruiting Phase 1 Interventional

Gilteritinib for the Treatment of ALK NSCLC

NCT06225427
View directory record Official record
Conditions
Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Interventions
Biopsy, Biospecimen Collection, Computed Tomography, Echocardiography, Gilteritinib, Magnetic Resonance Imaging, Questionnaire Administration
Procedure · Drug · Other
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
3
States / cities
Los Angeles, California • Washington D.C., District of Columbia • Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jun 25, 2026 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 2 Interventional Results available

A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission

NCT02927262
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
Interventions
Gilteritinib, Placebo
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years and older
Enrollment
98 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
6
States / cities
Gainesville, Florida • Jacksonville, Florida • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Nov 25, 2024 · Synced Sep 3, 2026, 1:02 AM EDT
Completed Phase 1 Interventional

A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

NCT03625505
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML)
Interventions
Venetoclax, Gilteritinib
Drug
Lead sponsor
AbbVie
Industry
Eligibility
18 Years and older
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
11
States / cities
Los Angeles, California • San Francisco, California • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Sep 13, 2021 · Synced Sep 3, 2026, 1:02 AM EDT
Withdrawn Phase 1 Interventional

GM-CLAG in Relapsed/Refractory FLT3-mutated AML

NCT05330377
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Gilteritinib 40 MG Oral Tablet, Cladribine, Cytarabine, Filgrastim, Mitoxantrone
Drug
Lead sponsor
Ayman H Qasrawi
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2032
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Apr 24, 2023 · Synced Sep 3, 2026, 1:02 AM EDT