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|Profile Name||FLT3 I836X|
|Gene Variant Detail|
|Relevant Treatment Approaches|
|Molecular Profile||Indication/Tumor Type||Response Type||Relevant Treatment Approaches||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|FLT3 I836X||acute myeloid leukemia||sensitive||Cytarabine + Daunorubicin + Midostaurin||FDA approved - On Companion Diagnostic||Actionable||In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (74.7 mo vs 25.6 mo) in patients with FLT3-mutant (D835X and I836X) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114).||detail... detail... 28644114|
|FLT3 I836X||acute myeloid leukemia||sensitive||Gilteritinib||FDA approved - On Companion Diagnostic||Actionable||In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) treatment resulted in complete remission (CR) or CR with partial hematologic recovery in 21% (29/138) of patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD), D835, or I836 mutation (FDA.gov; NCT02421939).||detail... detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|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|
|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|