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    Association details:
    Biomarker:FLT3 D835
    Cancer:Acute Myelogenous Leukemia
    Drug:Xospata (gilteritinib) (Multi-tyrosine kinase inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

    Excerpt:
    ...- Patient has presence of the FLT3 mutation (internal tandem duplication and/or tyrosine kinase domain [D835/I836] mutation) in bone marrow or peripheral blood....
    Trial ID:
    NCT03409081
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

    Excerpt:
    ...- Participant is positive for FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] and/or tyrosine kinase domain [TKD] [D835/I836] mutation) in bone marrow or whole blood as determined by the central laboratory....
    Trial ID:
    NCT05520567
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

    Excerpt:
    ...Participants can be enrolled from a local test result if they have any of the following FLT3 mutations: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD)/D835 or FLT3- TKD/I836....
    Trial ID:
    ADMIRAL
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Individual Patient Expanded Access Gilteritinib (ASP2215)

    Excerpt:
    ...Subject has presence of the FLT3 mutation (internal tandem duplication [ITD] and/or tyrosine kinase domain [TKD] [D835/I836] mutation) in bone marrow or peripheral blood as determined by local laboratory....
    Trial ID:
    NCT03315299
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    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

    Excerpt:
    ...- Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD] [D835/I836] mutation) (or for...
    Trial ID:
    LACEWING
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

    Excerpt:
    ...Subjects can be enrolled from a local test result if the subjects have any of the following FLT3 mutations: FLT3-internal tandem duplication (ITD), FLT3-tyrosine kinase domain (TKD)/D835 or FLT3-TKD/I836....
    Trial ID:
    COMMODORE
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Hematol Oncol
    Title:

    Outcomes with sequential FLT3-inhibitor-based therapies in patients with AML

    Published date:
    10/08/2020
    Excerpt:
    A total of 239 patients with FLT3-ITD- and/or FLT3-D835-mutated AML who received FLT3i-based treatments (including single-agent or combination FLT3i therapies) were identified...Of the 21 patients harboring D835 TKD mutations, 6 achieved CRc (30%): 14 received crenolanib (4 achieved CRc), 3 quizartinib (1 CRc), 2 gilteritinib (1 CRc), and 2 sorafenib (no CRc) as first FLT3i.
    DOI:
    10.1186/s13045-020-00964-5
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2018
    Title:

    RAS MUTATIONS ARE THE DOMINANT MECHANISM OF SECONDARY RESISTANCE TO GILTERITINIB THERAPY FOR RELAPSED/REFRACTORY FLT3-MUTATED AML

    Published date:
    05/17/2018
    Excerpt:
    CONTRADICTING EVIDENCE: Adults with R/R FLT3-mutated AML...At study enrollment 26/29 (89.7%) had a FLT3-ITD mutation, including 5 (17.2%) with both FLT3-ITD and FLT3-D835 mutations...Three subjects (10.3%) had a FLT3-D835 mutation only...23/29 progressed during gilteritinib therapy, 5 were withdrawn for transplant or toxicity, and one remains on gilteritinib in remission.
    Trial ID:
    NCT02014558
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Lancet Oncol
    Title:

    Selective Inhibition of FLT3 by Gilteritinib in Relapsed/Refractory Acute Myeloid Leukemia: a Multicenter, First-in-human, Open-label, Phase 1/2 Study

    Excerpt:
    ...gilteritinib monotherapy was well tolerated, generated high response rates and durable survival in FLT3mut+ R/R AML patients, including those with both FLT3-ITD and D835 mutations.
    DOI:
    10.1016/S1470-2045(17)30416-3
    Trial ID:
    NCT02014558