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ClinicalTrials.gov public records Last synced Jul 23, 2026, 10:48 PM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: FLT3-mutated Acute Myeloid Leukemia Clear all
Withdrawn Phase 1Phase 2 Interventional

Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

NCT04982354
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
CPX-351, Midostaurin, Busulfan, Melphalan, Fludarabine, CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Drug · Biological
Lead sponsor
Guenther Koehne
Other
Eligibility
18 Years to 74 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2032
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Sep 30, 2024 · Synced Jul 23, 2026, 10:48 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Withdrawn Phase 1 Interventional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 Jul 23, 2026, 10:48 PM EDT
Completed Phase 2 Interventional Results available

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

NCT01883362
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Midostaurin, Standard of Care
Drug · Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
18
States / cities
La Jolla, California • Los Angeles, California • Denver, Colorado + 14 more
Source: ClinicalTrials.gov public record
Updated Mar 16, 2021 · Synced Jul 23, 2026, 10:48 PM EDT
Recruiting Phase 2 Interventional

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

NCT06317649
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Azacitidine, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Gilteritinib, Venetoclax
Drug · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
147 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
225
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 179 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Jul 23, 2026, 10:48 PM EDT
Completed Phase 1 Interventional

Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia

NCT03900949
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Cytarabine, Daunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Midostaurin
Procedure · Drug
Lead sponsor
Uma Borate
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
2
States / cities
Columbus, Ohio • Portland, Oregon
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Jul 23, 2026, 10:48 PM EDT
Recruiting Phase 1Phase 2 Interventional

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

NCT04140487
View directory record Official record
Conditions
Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Refractory Acute Myeloid Leukemia, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic/Myeloproliferative Neoplasm
Interventions
Azacitidine, Gilteritinib, Venetoclax
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2028
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 15, 2026 · Synced Jul 23, 2026, 10:48 PM EDT
Completed Phase 1 Interventional

Sorafenib Tosylate Before and After Donor Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia

NCT01578109
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation
Interventions
Bone Marrow Transplantation, Sorafenib, Sorafenib Tosylate
Procedure · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2021
U.S. locations
2
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 1, 2024 · Synced Jul 23, 2026, 10:48 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, 10:48 PM EDT
Completed Phase 2 Interventional Results available

Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation

NCT02196857
View directory record Official record
Conditions
Leukemia
Interventions
Azacytidine, Sorafenib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 13, 2020 · Synced Jul 23, 2026, 10:48 PM EDT
Terminated Phase 2 Interventional Results available

A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia

NCT04209725
View directory record Official record
Conditions
Leukemia, Myeloid, Acute
Interventions
CPX-351, Quizartinib
Drug
Lead sponsor
SCRI Development Innovations, LLC
Other
Eligibility
18 Years to 80 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
5
States / cities
Denver, Colorado • Kansas City, Missouri • Nashville, Tennessee + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 4, 2023 · Synced Jul 23, 2026, 10:48 PM EDT
Terminated Phase 2 Interventional Results available

Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation

NCT02634827
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, FLT3 Tyrosine Kinase Domain Point Mutation, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Interventions
Decitabine, Laboratory Biomarker Analysis, Midostaurin
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
60 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 6, 2019 · Synced Jul 23, 2026, 10:48 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, 10:48 PM EDT
Terminated Phase 2 Interventional Results available

Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer

NCT03333486
View directory record Official record
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Leukemia in Remission, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Aplastic Anemia, B-Cell Non-Hodgkin Lymphoma, CD40 Ligand Deficiency, Chronic Granulomatous Disease, Chronic Leukemia in Remission, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Congenital Amegakaryocytic Thrombocytopenia, Congenital Neutropenia, Congenital Pure Red Cell Aplasia, Glanzmann Thrombasthenia, Immunodeficiency Syndrome, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Paroxysmal Nocturnal Hemoglobinuria, Plasma Cell Myeloma, Polycythemia Vera, Recurrent Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome, Severe Aplastic Anemia, Shwachman-Diamond Syndrome, Sickle Cell Disease, T-Cell Non-Hodgkin Lymphoma, Thalassemia, Waldenstrom Macroglobulinemia, Wiskott-Aldrich Syndrome
Interventions
Cyclophosphamide, Fludarabine Phosphate, Laboratory Biomarker Analysis, Peripheral Blood Stem Cell Transplantation, Total-Body Irradiation
Drug · Other · Procedure + 1 more
Lead sponsor
Roswell Park Cancer Institute
Other
Eligibility
1 Year to 75 Years
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Jul 3, 2025 · Synced Jul 23, 2026, 10:48 PM EDT
Completed Phase 3 Interventional

Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

NCT03258931
View directory record Official record
Conditions
Newly Diagnosed FLT3 Mutated AML
Interventions
Crenolanib, Midostaurin, Cytarabine, Duanorubicin
Drug
Lead sponsor
Arog Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
214 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2026
U.S. locations
31
States / cities
Duarte, California • Los Angeles, California • Sacramento, California + 18 more
Source: ClinicalTrials.gov public record
Updated Apr 8, 2026 · Synced Jul 23, 2026, 10:48 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, 10:48 PM EDT
Recruiting Phase 1 Interventional

Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia

NCT06366789
View directory record Official record
Conditions
AML With Gene Mutations
Interventions
ZE46-0134
Drug
Lead sponsor
Lomond Therapeutics Holdings, Inc.
Industry
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
12
States / cities
Los Angeles, California • San Francisco, California • Atlanta, Georgia + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 30, 2025 · Synced Jul 23, 2026, 10:48 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, 10:48 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, 10:48 PM EDT
Active, not recruiting Phase 2 Interventional

AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission

NCT04062266
View directory record Official record
Conditions
Acute Myeloid Leukemia in Remission, FLT3 Gene Mutation, Hematologic and Lymphocytic Disorder, Acute Myeloid Leukemia, Minimal Residual Disease Persistence, Therapy-Related Acute Myeloid Leukemia
Interventions
Azacitidine, Venetoclax
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2030
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Jul 23, 2026, 10:48 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, 10:48 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, 10:48 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

NCT01892371
View directory record Official record
Conditions
FLT3 Gene Mutation Negative, FLT3 Internal Tandem Duplication Positive, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic Syndrome
Interventions
Azacitidine, Cytarabine, Quizartinib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 5, 2025 · Synced Jul 23, 2026, 10:48 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

NCT02400281
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Crenolanib besylate, Idarubicin, Cytarabine, Azacytidine, Mitoxantrone, Etoposide, Fludarabine, G-CSF
Drug
Lead sponsor
Arog Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 2, 2024 · Synced Jul 23, 2026, 10:48 PM 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 Jul 23, 2026, 10:48 PM EDT