Molecular Profile Detail


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Profile Name FLT3 D835X
Gene Variant Detail

FLT3 D835X (unknown)

Relevant Treatment Approaches FLT3 Inhibitor


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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins FLT3 D835X acute myeloid leukemia sensitive Selinexor + Sorafenib Phase Ib/II Actionable In a Phase I/II trial, combination of Selinexor and Nexavar (sorafenib) treatment resulted in complete remission in 29% (4/14) and more than 50% blast reduction in 14% (2/14) of patients with acute myeloid leukemia harboring FLT3 ITD and/or D835 mutations (ASH, 59th Annual Meeting and Exposition, Dec 2017, Abstract 1344; NCT01607892). detail...
FLT3 exon 14 ins FLT3 D835X acute myeloid leukemia sensitive Crenolanib Phase I Actionable In a Phase I trial, Crenolanib treatment resulted in an overall survival (OS) of 128 days in AML patients harboring both FLT3 D835X and exon 14 insertion (ITD) that received no prior therapy, and an OS of 63 days in those progressed on TKIs (J Clin Oncol 34, 2016 (suppl; abstr 7008)). detail...
Clinical Trial Phase Therapies Title Recruitment Status
NCT02335814 Phase I FLX925 First-in-Human Study of FLX925 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia Terminated
NCT02400255 Phase II Crenolanib Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients Recruiting
NCT02752035 Phase II Gilteritinib Azacitidine + Gilteritinib Azacitidine 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 Recruiting
NCT03250338 Phase III Cytarabine + Filgrastim + Fludarabine + Idarubicin + Mitoxantrone Crenolanib + Cytarabine + Filgrastim + Fludarabine + Idarubicin + Mitoxantrone Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML Recruiting
NCT03512197 Phase III Daunorubicin + Midostaurin Cytarabine + Idarubicin + Midostaurin Cytarabine + Idarubicin Daunorubicin A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML) Active, not recruiting