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Acute Myeloid Leukemia (AML)

AML is driven by cytogenetic and molecular abnormalities that are pathogenic.1 Cytogenetic and molecular changes can alter the prognosis of AML, and can also potentially affect treatment decisions.1, 2

The FLT3 receptor is a tyrosine kinase receptor that is expressed on hematopoietic stem cells and plays a role in proliferation and differentiation.2 FLT3 has been shown to be overexpressed in the majority of AML cases, and is mutated in 1/3 of AML cases.2 FLT3 mutations are pathogenic in AML and cause leukemic cell proliferation, impaired hematopoietic stem cell differentiation, and prolonged survival of malignant clones.3

There are 2 common classes of FLT3 mutations: internal tandem duplication (ITD) mutations, and tyrosine kinase domain (TKD) mutations.3 ITD mutations lead to constitutive activation of the receptor and are associated with worsened clinical outcomes, including a worse disease free survival and overall survival.4 TKD mutations are less clearly linked to prognosis.3

Overview of Astellas FLT3+ AML Clinical Development Program

The safety and efficacy of the agent under investigation have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for uses being investigated. All information current as of August 2017.

National Clinical Trial (NCT) #
PHASE OF DEVELOPMENT
STUDY NAME
Study Description
NCT02421939
Phase III
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation5
Find out more
NCT02927262
Phase III
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 Remission6
Find out more
NCT02997202
Phase III
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)7
Find out more
NCT02752035
Phase II/III
A Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation in Patients Not Eligible for Intensive Induction Chemotherapy8
Find out more
NCT02236013
Phase I
A Phase 1 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia9
*Trial being conducted in the United States
Find out more
NCT02310321
Phase I
A Phase 1 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia10
*Trial being conducted in Japan
Find out more
National Clinical Trial (NCT) #
NCT02421939
PHASE OF DEVELOPMENT
Phase III
STUDY NAME
Study Description

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

Find out more
National Clinical Trial (NCT) #
NCT02927262
PHASE OF DEVELOPMENT
Phase III
STUDY NAME
Study Description
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
Find out more
National Clinical Trial (NCT)
NCT02997202
PHASE OF DEVELOPMENT
Phase III
STUDY NAME
Study Description
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)
Find out more
National Clinical Trial (NCT) #
NCT02752035
PHASE OF DEVELOPMENT
Phase II/III
STUDY NAME
Study Description
A Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Find out more
National Clinical Trial (NCT) #
NCT02236013
PHASE OF DEVELOPMENT
Phase I
Study Description
A Phase 1 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
*Trial being conducted in the United States
Find out more
National Clinical Trial (NCT) #
NCT02310321
PHASE OF DEVELOPMENT
Phase I
Study Description
A Phase 1 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
*Trial being conducted in Japan
Find out more
1. Saultz JN, Garzon R. Acute myeloid leukemia: a concise review. J Clin Med. 2016;5(3):33. 2. Theide C, Steudel C, Mohr B, et al. Analysis of FLT3-activating mutations in 979 patients with acute myelogenous leukemia: association with FAB subtypes and identification of subgroups with poor prognosis. Blood 2002;99(12):4326-35. 3. Walker A, Marcucci G. Molecular prognostic factors in cytogenetically normal acute myeloid leukemia. Exp Rev Hematol 2012;5(5):547-58. 4. Kayser S, Levis MJ. FLT3 tyrosine kinase inhibitors in acute myeloid leukemia: clinical implications and limitations. Leukemia Lymphoma 2014;55(2):243-55. 5. ClinicalTrials.gov. A study of ASP2215 versus salvage chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) with FMS-like tyrosine kinase (FLT3) mutation (07-25-2017). https://clinicaltrials.gov/ct2/show/NCT02421939?term=NCT02421939&rank=1. Accessed 07-27-2017. 6. ClinicalTrials.gov. A study of ASP2215 (gilteritinib), administered as maintenance therapy following indication/consolidation therapy for subjects with FMS-like tyrosine kinase 3 (FLT3/ITD) acute myeloid leukemia (AML) in first complete remission (06-26-2017). https://clinicaltrials.gov/ct2/show/NCT02927262?term=NCT02927262&rank=1. Accessed 07-27-2017. 7. ClinicalTrials.gov. 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) (07-18-2017). https://clinicaltrials.gov/ct2/show/NCT02997202?term=NCT02997202&rank=1. Accessed 07-26-2017. 8. ClinicalTrials.gov. A study of ASP2215 (gilteritinib), combination of ASP2215 plus azacitidine and azacitidine alone in the treatment of newly diagnosed acute myeloid leukemia with FMS-like tyrosine kinase (FLT3) mutation in patients not eligible for intensive induction chemotherapy (05-23-2017). https://clinicaltrials.gov/ct2/show/NCT02752035?term=NCT02752035&rank=1. Accessed 07-27-2017. 9. ClinicalTrials.gov. A phase 1 study of ASP2215 in combination with induction and consolidation chemotherapy in patients with newly diagnosed acute myeloid leukemia (05-04-2017). https://clinicaltrials.gov/ct2/show/NCT02236013?term=NCT02236013&rank=1. Accessed 05-10-2017. 10. ClinicalTrials.gov. A study of ASP2215 in combination with induction and consolidation chemotherapy in Japanese patients with newly diagnosed acute myeloid leukemia (03-27-2017). https://clinicaltrials.gov/ct2/show/NCT02310321?term=NCT02310321&rank=1. Accessed 05-15-2017.