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Gilteritinib (ASP2215) in Relapsed/Refractory FLT3+
Acute Myeloid Leukemia (AML)

2215-CL-0301 / NCT02421939

A phase 3 open-label, multi-center, randomized study of gilteritinib versus salvage chemotherapy in patients with FLT3 mutations who are refractory to or have relapsed after first-line AML therapy.

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.

Now Enrolling
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Selection Criteriaa

• Refractory or relapsed after first-line AML therapy

• Positive for FLT3-activating mutation (ITD, D835/I836 TKD point mutation)

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

aNot a complete list of selection criteria.


Find out more at
Astellas Pharma
800-888-7704, ext 5473

CR, complete remission; CRi, complete remission with incomplete hematologic recovery; CRp, complete remission with incomplete platelet recovery. 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). Accessed 07-27-2017.