Last updated on July 2018

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


Brief description of study

This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster. For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster. This study will compare three different treatments. Patients are assigned to one of these three groups by chance: an experimental medicine gilteritinib, a different medicine called azacitidine, also known as Vidaza, or both medicines (azacitidine and gilteritinib) together. The clinical study may help show which treatment helps patients live longer.

Detailed Study Description

Subjects considered an adult according to local regulation at the time of obtaining informed consent may participate in the study.

Safety Cohort Prior to initiation of the randomized trial, 8 to 12 subjects will be enrolled to evaluate the safety and tolerability of ASP2215 given with azacitidine therapy in the study population.

Randomized Trial Approximately 528 subjects will be randomized in a 1:1:1 ratio to receive ASP2215 (Arm A), ASP2215 plus azacitidine (Arm AC) or azacitidine only (Arm C).

Subjects will enter the screening period up to 14 days prior to the start of treatment. Subjects will be administered treatment over 28-day cycles.

Clinical Study Identifier: NCT02752035

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Astellas Pharma Global Development

Site KR82002
Seoul, Korea, Republic of
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Astellas Pharma Global Development

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Seoul, Korea, Republic of
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Astellas Pharma Global Development

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Seoul, Korea, Republic of
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Astellas Pharma Global Development

Site KR82008
Seoul, Korea, Republic of
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