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Gilteritinib (ASP2215) as Maintenance Therapy in FLT3/ITD+ Acute Myeloid Leukemia (AML) Patients Following Hematopoietic Stem Cell Transplant

2215-CL-0304/ NCT02997202

A phase 3 double-blind, multicenter, randomized, placebo-controlled study of gilteritinib (ASP2215) as maintenance therapy following hematopoietic stem cell transplant (HCT) in AML patients with FLT3/ITD.

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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Key Registration Criteriaa

• In CR after 1 or 2 cycles of induction therapy

• Candidate for HSCT

• Presence of FLT3/ITD activating mutations


Key Randomization Criteriaa

• Patients within 30 - 90 days post-transplant

• In continuous CR after transplant

aNot a complete list of selection criteria.


Find out more at
Astellas Pharma
800-888-7704, ext 5473 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). Accessed 07-26-2017.