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ClinicalTrials.gov public records Last synced Sep 15, 2026, 9:29 PM EDT

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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Gilteritinib Oral Tablet Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects

NCT03964038
View directory record Official record
Conditions
Healthy Volunteer
Interventions
gilteritinib, gilteritinib mini tablet
Drug
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 15, 2024 · Synced Sep 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM EDT
Terminated Phase 1 Interventional

A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

NCT04336982
View directory record Official record
Conditions
Leukemia, Myeloid, Acute
Interventions
CC-90009, Venetoclax, Azacitidine, Gilteritinib
Drug
Lead sponsor
Celgene
Industry
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
7
States / cities
San Francisco, California • New Haven, Connecticut • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated May 30, 2024 · Synced Sep 15, 2026, 9:29 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT05028751
View directory record Official record
Conditions
Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Lanraplenib, Gilteritinib
Drug
Lead sponsor
Kronos Bio
Industry
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
8
States / cities
Los Angeles, California • Atlanta, Georgia • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2024 · Synced Sep 15, 2026, 9:29 PM EDT
Active, not recruiting Phase 1 Interventional

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

NCT05546580
View directory record Official record
Conditions
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Interventions
Iadademstat, Gilteritinib Oral Tablet
Drug
Lead sponsor
Oryzon Genomics S.A.
Industry
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
13
States / cities
Gilbert, Arizona • Tucson, Arizona • Miami, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Aug 23, 2026 · Synced Sep 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM EDT
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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM EDT
Recruiting Phase 2Phase 3 Interventional

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

NCT03013998
View directory record Official record
Conditions
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Interventions
Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1), Azacitidine (BAML-16-001-S2), AG-221 (BAML-16-001-S3), Azacitidine (BAML-16-001-S3), Entospletinib (BAML-16-001-S4), Azacitidine (BAML-16-001-S4), Entospletinib (BAML-16-001-S5), Decitabine (BAML-16-001-S5), Entospletinib (BAML-16-001-S6), Daunorubicin (BAML-16-001-S6), Cytarabine (BAML-16-001-S6), Pevonedistat (BAML-16-001-S9), Azacitidine (BAML-16-001-S9), AG-120 (BAML-16-001-S16), Azacitidine (BAML-16-001-S16), Gilteritinib (BAML-16-001-S8 Group 1), Decitabine (BAML-16-001-S8 Group 1), AZD5153 (BAML-16-001-S10), Venetoclax (BAML-16-001-S10), TP-0903 (BAML-16-001-S14), Decitabine (BAML-16-001-S14), Decitabine (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S8 Group 2), AZD5991 (BAML-16-001-S18), Azacitidine (BAML-16-001-S18), SNDX-5613 (BAML-16-001-S17), Azacitidine (BAML-16-001-S17), Venetoclax (BAML-16-001-S17), Gilteritinib (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S12 Arm A), Azacitidine (BAML-16-001-S12 Arm A), Venetoclax (BAML-16-001-S12 Arm B), Azacitidine (BAML-16-001-S12 Arm B), ZE46-0134 (BAML-16-001-S21 Group 1), ficlatuzumab (BAML-16-001-S24), Azacitidine (BAML-16-001-S24), Venetoclax (BAML-16-001-S24), ZE46-0134 (BAML-16-001-S21 Group 2), Bleximenib (BAML-16-001-S25/HO181), Cytarabine (BAML-16-001-S25/HO181), Daunorubicin or Idarubicin (BAML-16-001-S25/HO181), Placebo (BAML-16-001-S25/HO181), Revumenib (BAML-16-001-S26/HO177), Placebo (BAML-16-001-S26/HO177)
Biological · Other · Drug
Lead sponsor
Beat AML, LLC
Other
Eligibility
18 Years and older
Enrollment
3,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2032
U.S. locations
31
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Los Angeles, California + 26 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM 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 15, 2026, 9:29 PM EDT