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Gilteritinib (ASP2215), Gilteritinib + Azacitidine, or Azacitidine In Newly Diagnosed FLT3+ Acute Myeloid Leukemia (AML) Patients Not Eligible for Intensive Induction Chemotherapy

2215-CL-0201 / NCT02752035

A phase 2/3, open-label, multicenter, randomized study of gilteritinib (ASP2215) monotherapy, combination of gilteritinib plus azacitidine, and azacitidine monotherapy in newly diagnosed AML patients with FLT3 mutations that are not eligible for intensive induction chemotherapy.

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

• Diagnosis of previously untreated AML

• Ineligible for intensive induction chemotherapy

• Positive for FLT3 mutation

aNot a complete list of selection criteria.

Contact

Find out more at ClinicalTrials.gov
Astellas Pharma
800-888-7704, ext 5473
Astellas.registration@astellas.com

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.