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Showing 1–11 of 11 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation Clear all
Completed Phase 1 Interventional

Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations

NCT00943943
View directory record Official record
Conditions
Acute Myelogenous Leukemia, Leukemia
Interventions
G-CSF, Plerixafor, Sorafenib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2017
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 28, 2017 · Synced Jul 23, 2026, 2:23 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 Jul 23, 2026, 2:23 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 Jul 23, 2026, 2:23 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 Jul 23, 2026, 2:23 PM 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 Jul 23, 2026, 2:23 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 Jul 23, 2026, 2:23 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

NCT03793478
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Quizartinib, Fludarabine, Cytarabine, Intrathecal (IT) triple chemotherapy prophylaxis, Etoposide
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
1 Month to 21 Years
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
11
States / cities
Loma Linda, California • San Francisco, California • Aurora, Colorado + 8 more
Source: ClinicalTrials.gov public record
Updated Mar 31, 2026 · Synced Jul 23, 2026, 2:23 PM EDT
Completed Phase 1Phase 2 Interventional Results available

PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)

NCT00045942
View directory record Official record
Conditions
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Interventions
Itraconazole, PKC412
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
144 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2008
U.S. locations
4
States / cities
Los Angeles, California • Boston, Massachusetts • New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 10, 2017 · Synced Jul 23, 2026, 2:23 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 Jul 23, 2026, 2:23 PM EDT
No Longer Available No phase listed Expanded access

Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy

NCT02624570
View directory record Official record
Conditions
Acute Myeloid Leukemia (AML) With, FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)
Interventions
Midostaurin
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
44
States / cities
Phoenix, Arizona • Berkeley, California • Duarte, California + 35 more
Source: ClinicalTrials.gov public record
Updated Jul 14, 2020 · Synced Jul 23, 2026, 2:23 PM EDT
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 – 2025
U.S. locations
13
States / cities
Gilbert, Arizona • Tucson, Arizona • Miami, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2024 · Synced Jul 23, 2026, 2:23 PM EDT