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Showing 1–24 of 38 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: FLT3 Internal Tandem Duplication Clear all
Completed Phase 2 Interventional Results available

Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)

NCT00989261
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Compound AC220
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 85 Years
Enrollment
333 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2014
U.S. locations
20
States / cities
San Francisco, California • Chicago, Illinois • Indianapolis, Indiana + 14 more
Source: ClinicalTrials.gov public record
Updated Dec 10, 2019 · Synced Jul 23, 2026, 3:43 AM EDT
Terminated Phase 1 Interventional

A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

NCT04477291
View directory record Official record
Conditions
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Interventions
CG-806
Drug
Lead sponsor
Aptose Biosciences Inc.
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
10
States / cities
Duarte, California • Los Angeles, California • Miami, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Mar 6, 2025 · Synced Jul 23, 2026, 3:43 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 Jul 23, 2026, 3:43 AM EDT
Completed Phase 2 Interventional Results available

Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies

NCT01760655
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Follicular Lymphoma, Hodgkin Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Myeloid Leukemia, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Polycythemia Vera, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
Interventions
Fludarabine phosphate, Busulfan, Total-Body Irradiation, Therapeutic Allogeneic Lymphocytes, Cyclophosphamide, Allogeneic Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Tacrolimus, Mycophenolate Mofetil, Laboratory Biomarker Analysis
Drug · Radiation · Biological + 2 more
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Eligibility
Not listed
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2022
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 29, 2025 · Synced Jul 23, 2026, 3:43 AM 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, 3:43 AM EDT
Completed Phase 3 Interventional Results available

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT01371981
View directory record Official record
Conditions
Acute Myeloid Leukemia, Leukemia Cutis, Myeloid Neoplasm, Myeloid Sarcoma
Interventions
Asparaginase, Bortezomib, Cytarabine, Daunorubicin Hydrochloride, Etoposide, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Pharmacological Study, Quality-of-Life Assessment, Questionnaire Administration, Sorafenib Tosylate
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
Up to 29 Years
Enrollment
1,645 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2026
U.S. locations
195
States / cities
Birmingham, Alabama • Mobile, Alabama • Mesa, Arizona + 143 more
Source: ClinicalTrials.gov public record
Updated Jun 1, 2026 · Synced Jul 23, 2026, 3:43 AM EDT
Completed Phase 2 Interventional Results available

Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

NCT01253070
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Acute Promyelocytic Leukemia With PML-RARA, FLT3 Gene Mutation, Therapy-Related Acute Myeloid Leukemia
Interventions
Biopsy, Bone Marrow Aspiration, Cytarabine, Daunorubicin Hydrochloride, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Sorafenib Tosylate
Procedure · Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
60 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2021
U.S. locations
43
States / cities
Lewes, Delaware • Newark, Delaware • Orlando, Florida + 35 more
Source: ClinicalTrials.gov public record
Updated Aug 3, 2022 · Synced Jul 23, 2026, 3:43 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype

NCT01534260
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
sorafenib, vorinostat and bortezomib
Drug
Lead sponsor
Hamid Sayar
Other
Eligibility
18 Years and older
Enrollment
37 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Aug 16, 2018 · Synced Jul 23, 2026, 3:43 AM EDT
Active, not recruiting Phase 1 Interventional

Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia

NCT03513484
View directory record Official record
Conditions
Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Fibroblast Growth Factor Basic Form Measurement, FLT3 Internal Tandem Duplication, Recurrent Adult Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Azacitidine, Laboratory Biomarker Analysis, Nintedanib
Drug · Other
Lead sponsor
Northwestern University
Other
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2027
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Oct 20, 2025 · Synced Jul 23, 2026, 3:43 AM EDT
Completed Phase 2 Interventional Results available

Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT01565668
View directory record Official record
Conditions
Leukemia, Myeloid, Acute
Interventions
AC220
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
18
States / cities
Los Angeles, California • Chicago, Illinois • Baltimore, Maryland + 12 more
Source: ClinicalTrials.gov public record
Updated Dec 26, 2019 · Synced Jul 23, 2026, 3:43 AM EDT
Terminated Phase 1 Interventional Results available

Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

NCT03552029
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
Quizartinib, Milademetan
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
8
States / cities
Los Angeles, California • New Haven, Connecticut • Fairway, Kansas + 5 more
Source: ClinicalTrials.gov public record
Updated May 19, 2022 · Synced Jul 23, 2026, 3:43 AM EDT
Completed Phase 2 Interventional Results available

Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia

NCT00553202
View directory record Official record
Conditions
Leukemia
Interventions
anti-thymocyte globulin, busulfan, cyclophosphamide, cyclosporine, methotrexate, methylprednisolone, tacrolimus, laboratory biomarker analysis, pharmacological study, allogeneic bone marrow transplantation, allogeneic hematopoietic stem cell transplantation
Biological · Drug · Other + 1 more
Lead sponsor
Children's Oncology Group
Network
Eligibility
Up to 30 Years
Enrollment
158 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2020
U.S. locations
48
States / cities
Birmingham, Alabama • Phoenix, Arizona • Long Beach, California + 45 more
Source: ClinicalTrials.gov public record
Updated Apr 15, 2020 · Synced Jul 23, 2026, 3:43 AM 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, 3:43 AM 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, 3:43 AM EDT
Recruiting Phase 1 Interventional

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

NCT06222580
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Interventions
Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Gilteritinib, Revumenib, Echocardiography Test, Multigated Acquisition Scan
Procedure · Drug
Lead sponsor
Uma Borate
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
4
States / cities
Chapel Hill, North Carolina • Columbus, Ohio • Philadelphia, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Jul 23, 2026, 3:43 AM EDT
Completed Phase 3 Interventional Results available

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

NCT02039726
View directory record Official record
Conditions
AML
Interventions
Quizartinib, Salvage Chemotherapy
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
367 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2020
U.S. locations
36
States / cities
Duarte, California • Los Angeles, California • Sacramento, California + 31 more
Source: ClinicalTrials.gov public record
Updated Feb 23, 2021 · Synced Jul 23, 2026, 3:43 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 Jul 23, 2026, 3:43 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT01349049
View directory record Official record
Conditions
Acute Myeloid Leukemia
Interventions
PLX3397
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
9
States / cities
San Francisco, California • Chicago, Illinois • Baltimore, Maryland + 5 more
Source: ClinicalTrials.gov public record
Updated Mar 1, 2020 · Synced Jul 23, 2026, 3:43 AM 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, 3:43 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia

NCT03735875
View directory record Official record
Conditions
Acute Myeloid Leukemia With FLT3/ITD Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Leukemia
Interventions
Quizartinib, Venetoclax
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Jul 23, 2026, 3:43 AM EDT
Active, not recruiting Phase 3 Interventional

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

NCT06578247
View directory record Official record
Conditions
Leukemia
Interventions
Quizartinib, Placebo, Chemotherapy
Drug
Lead sponsor
Daiichi Sankyo
Industry
Eligibility
18 Years to 70 Years
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
52
States / cities
Goodyear, Arizona • Phoenix, Arizona • Tucson, Arizona + 43 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2026 · Synced Jul 23, 2026, 3:43 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 Jul 23, 2026, 3:43 AM 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, 3:43 AM 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, 3:43 AM EDT