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    BIOMARKER:

    FLT3-ITD mutation

    i
    Other names: FLT3, Fms Related Tyrosine Kinase 3, Receptor-Type Tyrosine-Protein Kinase FLT3, Stem Cell Tyrosine Kinase 1, Fms-Like Tyrosine Kinase 3, CD135, FLK-2, STK1, Growth Factor Receptor Tyrosine Kinase Type III, Fetal Liver Kinase 2
    Entrez ID:
    2322
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    Apply
    Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene (NCT05886049)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    06/20/2024
    Primary completion :
    12/31/2027
    Completion :
    12/31/2027
    FLT3 • NPM1 • KMT2A
    |
    FLT3-ITD mutation • FLT3 mutation • NPM1 mutation • MLL mutation
    |
    daunorubicin • Revuforj (revumenib) • Starasid (cytarabine ocfosfate)
    Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) (NCT05554393)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    02/20/2025
    Initiation :
    09/13/2024
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    TP53 • FLT3 • NPM1 • RUNX1 • ASXL1 • RARA • RUNX1T1 • PML • CEBPA
    |
    TP53 mutation • FLT3-ITD mutation • NPM1 mutation • RUNX1 mutation • ASXL1 mutation • FLT3-TKD mutation
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • Starasid (cytarabine ocfosfate)
    A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults with FLT3-ITD Relapse/refractory (R/R) AML (AGORA-1) (NCT05199051)
    Phase 2
    Centre Antoine Lacassagne
    Recruiting
    Last update posted :
    02/19/2025
    Initiation :
    06/03/2023
    Primary completion :
    03/15/2027
    Completion :
    03/15/2027
    FLT3 • CD33
    |
    FLT3-ITD mutation • FLT3-TKD mutation • CD33 positive
    |
    cytarabine • Xospata (gilteritinib) • Mylotarg (gemtuzumab ozogamicin)
    Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome (NCT05457556)
    Phase 3
    Children's Oncology Group
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    03/15/2023
    Primary completion :
    12/01/2027
    Completion :
    12/01/2027
    FLT3 • ABL1 • BCR • NPM1 • HLA-DRB1 • CEBPA • HLA-DQB1 • HLA-B • HLA-C
    |
    FLT3-ITD mutation
    |
    Rituxan (rituximab) • cyclophosphamide • methotrexate • melphalan • Truxima (rituximab-abbs) • fludarabine IV • thiotepa • busulfan • Mabtas (rituximab biosimilar)
    ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCI-2021-06095) (NCT05010122)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/13/2025
    Initiation :
    07/08/2021
    Primary completion :
    01/30/2026
    Completion :
    01/30/2026
    FLT3
    |
    FLT3-ITD mutation • FLT3 mutation
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • Inqovi (decitabine/cedazuridine)
    Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (NCI-2018-01789) (NCT03661307)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    10/31/2018
    Primary completion :
    01/01/2026
    Completion :
    01/01/2026
    TP53 • FLT3
    |
    TP53 mutation • FLT3-ITD mutation • FLT3 mutation • TP53 deletion
    |
    Venclexta (venetoclax) • azacitidine • Vanflyta (quizartinib) • decitabine
    Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AAML1031) (NCT01371981)
    Phase 3
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    06/20/2011
    Primary completion :
    03/31/2019
    Completion :
    09/30/2027
    FLT3
    |
    FLT3-ITD mutation
    |
    sorafenib • cytarabine • bortezomib • etoposide IV • daunorubicin • mitoxantrone • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate)
    Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients with Hematologic Malignancies (HTLP-ONCO) (NCT04707300)
    Phase 1/2
    Assistance Publique - Hôpitaux de Paris
    Recruiting
    Last update posted :
    02/03/2025
    Initiation :
    02/16/2022
    Primary completion :
    11/01/2025
    Completion :
    08/01/2027
    HLA-DRB1 • CD34 • CD4 • CD7
    |
    FLT3-ITD mutation • NPM1 mutation
    |
    SMART 102
    A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML) (NCT04027309)
    Phase 3
    Stichting Hemato-Oncologie voor Volwassenen Ned...
    Active, not recruiting
    Last update posted :
    12/17/2024
    Initiation :
    12/20/2019
    Primary completion :
    10/01/2025
    Completion :
    06/01/2033
    FLT3
    |
    FLT3-ITD mutation • FLT3 mutation • FLT3-TKD mutation
    |
    Xospata (gilteritinib) • midostaurin
    A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant (HBO-UBC) (NCT03739502)
    Phase 2
    University of Rochester
    Recruiting
    Last update posted :
    08/19/2024
    Initiation :
    02/28/2019
    Primary completion :
    04/01/2025
    Completion :
    04/01/2026
    FLT3 • ABL1 • BCR • NPM1 • CD22 • CD34 • CD79A
    |
    FLT3-ITD mutation • NPM1 mutation
    Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML (NCT05024552)
    Phase 1
    H. Lee Moffitt Cancer Center and Research Insti...
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    08/23/2021
    Primary completion :
    08/01/2024
    Completion :
    08/01/2025
    FLT3
    |
    FLT3-ITD mutation • FLT3-TKD mutation
    |
    Xospata (gilteritinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia. (NCT02310321)
    Phase 1/2
    Astellas Pharma Inc
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    02/26/2015
    Primary completion :
    08/25/2021
    Completion :
    07/31/2024
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride
    A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies (NCT03522142)
    Phase 1
    Incyte Corporation
    Active, not recruiting
    Last update posted :
    06/06/2024
    Initiation :
    08/27/2018
    Primary completion :
    11/30/2024
    Completion :
    12/31/2024
    FLT3 • MSI • IDH1 • IDH2
    |
    MSI-H/dMMR • FLT3-ITD mutation • FLT3 wild-type • IDH wild-type
    |
    Zynyz (retifanlimab-dlwr) • INCB81776
    Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) (APAL2020D) (NCT05183035)
    Phase 3
    LLS PedAL Initiative, LLC
    Recruiting
    Last update posted :
    06/03/2024
    Initiation :
    10/01/2022
    Primary completion :
    02/01/2027
    Completion :
    02/01/2032
    FLT3 • BCL2
    |
    FLT3-ITD mutation
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • Mylotarg (gemtuzumab ozogamicin) • fludarabine IV
    Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations (NCI-2020-05261) (NCT04493138)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    07/21/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    TP53 • FLT3 • ASXL1
    |
    TP53 mutation • FLT3-ITD mutation • ASXL1 mutation • CBL mutation
    |
    azacitidine • Vanflyta (quizartinib)
    A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation (COMMODORE) (NCT03182244)
    Phase 3
    Astellas Pharma Inc
    Active, not recruiting
    Last update posted :
    05/24/2024
    Initiation :
    01/15/2018
    Primary completion :
    12/25/2023
    Completion :
    03/31/2026
    FLT3
    |
    FLT3-ITD mutation • FLT3 mutation • FLT3 D835 • FLT3 I836
    |
    cytarabine • Xospata (gilteritinib) • etoposide IV • mitoxantrone • fludarabine IV
    A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation (ADMIRAL) (NCT02421939)
    Phase 3
    Astellas Pharma Global Development, Inc.
    Active, not recruiting
    Last update posted :
    05/23/2024
    Initiation :
    10/20/2015
    Primary completion :
    09/17/2018
    Completion :
    07/31/2024
    FLT3
    |
    FLT3-ITD mutation • FLT3 mutation • FLT3 D835 • FLT3 I836
    |
    cytarabine • Xospata (gilteritinib) • azacitidine • etoposide IV • idarubicin hydrochloride • mitoxantrone • fludarabine IV
    Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy (NCT03674411)
    Phase 2
    Masonic Cancer Center, University of Minnesota
    Active, not recruiting
    Last update posted :
    04/10/2024
    Initiation :
    01/02/2019
    Primary completion :
    06/23/2020
    Completion :
    06/28/2024
    FLT3 • NPM1 • KMT2A • HLA-DRB1 • CEBPA
    |
    FLT3-ITD mutation • NPM1 mutation • MLL rearrangement • MLL rearrangement • CEBPA mutation • FLT3 wild-type
    |
    cyclophosphamide • melphalan • fludarabine IV • busulfan • cyclophosphamide intravenous • spanlecortemlocel (MGTA-456)
    Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance (NCT02756962)
    Phase 2
    Washington University School of Medicine
    Active, not recruiting
    Last update posted :
    04/02/2024
    Initiation :
    07/06/2016
    Primary completion :
    07/31/2033
    Completion :
    07/31/2033
    FLT3 • NPM1 • CEBPA
    |
    FLT3-ITD mutation • NPM1 mutation • CEBPA mutation
    |
    cytarabine • midostaurin
    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) (MORPHO) (NCT02997202)
    Phase 3
    Astellas Pharma Global Development, Inc.
    Completed
    Last update posted :
    03/15/2024
    Initiation :
    06/07/2017
    Primary completion :
    03/01/2023
    Completion :
    05/09/2023
    FLT3
    |
    FLT3-ITD mutation
    |
    Xospata (gilteritinib)
    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 (NCI-2019-04959) (NCT04140487)
    Phase 1/2
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    03/15/2024
    Initiation :
    12/17/2019
    Primary completion :
    09/01/2025
    Completion :
    09/01/2025
    FLT3
    |
    FLT3-ITD mutation • FLT3 mutation • FLT3 D835
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • azacitidine
    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 (GOSSAMER) (NCT02927262)
    Phase 2
    Astellas Pharma Global Development, Inc.
    Completed
    Last update posted :
    03/15/2024
    Initiation :
    01/10/2017
    Primary completion :
    05/25/2021
    Completion :
    02/19/2024
    FLT3
    |
    FLT3-ITD mutation
    |
    Xospata (gilteritinib)
    Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (PrE0905) (NCT03836209)
    Phase 2
    PrECOG, LLC.
    Active, not recruiting
    Last update posted :
    02/22/2024
    Initiation :
    12/06/2019
    Primary completion :
    10/17/2023
    Completion :
    12/01/2024
    FLT3
    |
    FLT3-ITD mutation • FLT3 mutation
    |
    cytarabine • Xospata (gilteritinib) • midostaurin • daunorubicin
    Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML (NCT03922100)
    Phase 1/2
    Nerviano Medical Sciences
    Recruiting
    Last update posted :
    02/21/2024
    Initiation :
    04/03/2019
    Primary completion :
    12/28/2025
    Completion :
    02/28/2026
    FLT3
    |
    FLT3-ITD mutation
    |
    NMS-088
    A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations (NCT02283177)
    Phase 2
    Arog Pharmaceuticals, Inc.
    Completed
    Last update posted :
    02/02/2024
    Initiation :
    01/01/2015
    Primary completion :
    12/01/2019
    Completion :
    12/01/2019
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • crenolanib (ARO-002) • daunorubicin • idarubicin hydrochloride
    Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations (NCT01522469)
    Phase 2
    Arog Pharmaceuticals, Inc.
    Completed
    Last update posted :
    01/30/2024
    Initiation :
    07/01/2012
    Primary completion :
    08/01/2014
    Completion :
    11/01/2014
    FLT3
    |
    FLT3-ITD mutation
    |
    crenolanib (ARO-002)
    A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia (NCT06017258)
    Phase 1
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    01/24/2024
    Initiation :
    08/22/2023
    Primary completion :
    08/22/2026
    Completion :
    08/22/2026
    FLT3 • IDH1 • IDH2 • IL18 • CD37
    |
    FLT3-ITD mutation • IDH1 mutation • IDH2 mutation • CD37 expression
    |
    CD371-YSNVZ-IL18 CAR T cells
    TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies (HAP2HCT) (NCT03849651)
    Phase 2
    St. Jude Children's Research Hospital
    Active, not recruiting
    Last update posted :
    01/19/2024
    Initiation :
    01/31/2019
    Primary completion :
    07/01/2024
    Completion :
    07/01/2025
    FLT3 • RUNX1 • KMT2A • ETV6 • WT1 • CREBBP • NUP98 • NSD1 • HOXA9 • NUP214 • CBFA2T3 • GLIS2 • KAT6A • KDM5A • DEK • AFDN • MLLT10
    |
    FLT3-ITD mutation • WT1 mutation • MLL fusion • NUP98-NSD1 fusion
    |
    cyclophosphamide • Blincyto (blinatumomab) • melphalan • fludarabine IV • mesna • thiotepa • Neupogen (filgrastim) • cyclophosphamide intravenous
    FLYSYN in MRD Positive AML (FLYSYN-101) (NCT02789254)
    Phase 1/2
    Synimmune GmbH
    Completed
    Last update posted :
    12/28/2023
    Initiation :
    02/07/2017
    Primary completion :
    09/27/2021
    Completion :
    09/27/2021
    FLT3 • NPM1
    |
    FLT3-ITD mutation • FLT3 wild-type • FLT3 expression
    |
    VX-A901
    Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood (NCT03793478)
    Phase 1/2
    Daiichi Sankyo, Inc.
    Recruiting
    Last update posted :
    12/11/2023
    Initiation :
    08/15/2018
    Primary completion :
    05/01/2027
    Completion :
    05/01/2027
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • etoposide IV • Vanflyta (quizartinib) • fludarabine IV
    A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations (NCT01657682)
    Phase 2
    Arog Pharmaceuticals, Inc.
    Completed
    Last update posted :
    11/30/2023
    Initiation :
    10/01/2012
    Primary completion :
    04/01/2019
    Completion :
    04/01/2019
    FLT3
    |
    FLT3-ITD mutation
    |
    crenolanib (ARO-002) • hydroxyurea
    Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies (NCT02543879)
    Phase 1
    Forma Therapeutics, Inc.
    Completed
    Last update posted :
    11/21/2023
    Initiation :
    09/01/2015
    Primary completion :
    03/01/2019
    Completion :
    03/01/2019
    FLT3
    |
    FLT3-ITD mutation
    |
    azacitidine • CC-95775
    Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First) (NCT02668653)
    Phase 3
    Daiichi Sankyo, Inc.
    Completed
    Last update posted :
    11/20/2023
    Initiation :
    09/01/2016
    Primary completion :
    08/13/2021
    Completion :
    06/16/2023
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • Vanflyta (quizartinib) • daunorubicin • idarubicin hydrochloride
    Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia (NCT03735875)
    Phase 1/2
    M.D. Anderson Cancer Center
    Completed
    Last update posted :
    10/16/2023
    Initiation :
    01/25/2019
    Primary completion :
    07/26/2023
    Completion :
    07/26/2023
    FLT3 • BCL2
    |
    FLT3-ITD mutation
    |
    Venclexta (venetoclax) • Vanflyta (quizartinib)
    Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes (NCT03121014)
    Phase 2
    University of Illinois at Chicago
    Recruiting
    Last update posted :
    07/04/2023
    Initiation :
    04/24/2017
    Primary completion :
    04/24/2024
    Completion :
    04/24/2024
    FLT3 • KMT2A • HLA-DRB1 • HLA-B • HLA-C
    |
    FLT3-ITD mutation • MLL rearrangement • MLL rearrangement • Chr t(9;11)
    |
    methotrexate • fludarabine IV • busulfan
    A Study of XY0206 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory AML With FLT3-ITD-Mutation (ALIVE) (NCT05876832)
    Phase 3
    Shijiazhuang Yiling Pharmaceutical Co. Ltd
    Not yet recruiting
    Last update posted :
    05/26/2023
    Initiation :
    06/15/2023
    Primary completion :
    07/01/2027
    Completion :
    07/01/2027
    FLT3
    |
    FLT3-ITD mutation
    |
    cytarabine • azacitidine • XY0206
    GM-CLAG in Relapsed/Refractory FLT3-mutated AML (NCT05330377)
    Phase 1
    Ayman H Qasrawi
    Withdrawn
    Last update posted :
    04/25/2023
    Initiation :
    03/01/2023
    Primary completion :
    05/30/2027
    Completion :
    05/30/2032
    FLT3
    |
    FLT3-ITD mutation • FLT3-TKD mutation
    |
    cytarabine • Xospata (gilteritinib) • mitoxantrone • cladribine • Neupogen (filgrastim)
    TL-895 and KRT-232 Study in Acute Myeloid Leukemia (NCT04669067)
    Phase 1b/2
    Telios Pharma, Inc.
    Active, not recruiting
    Last update posted :
    02/17/2023
    Initiation :
    03/31/2021
    Primary completion :
    11/01/2024
    Completion :
    11/01/2025
    TP53 • FLT3
    |
    FLT3-ITD mutation • FLT3 mutation • TP53 wild-type
    |
    navtemadlin (KRT-232) • M7583