The purpose of this study is to determine the clinical benefit of ASP2215 therapy in patients with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival compared to salvage chemotherapy. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
Subjects considered an adult according to local regulations at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive ASP2215 or salvage chemotherapy. Subjects will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subject; options will include low-dose cytarabine (LoDAC), azacitidine, mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC), or fludarabine, cytarabine, and granulocyte colony-stimulating factor (G-CSF) with idarubicin (FLAG-IDA). The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Subjects will be administered treatment over continuous 28-day cycles.
After treatment discontinuation, subjects will have an end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety, in which a telephone contact with the subject is sufficient unless any assessment must be repeated for resolution of treatment-related AEs. After that, long term follow-up will be done every 3 months up to 3 years from the 30 day follow-up.
Leukemia, Acute Myeloid (AML) ASP2215 Relapsed Acute Myeloid Leukemia FLT3 Mutation Refractory Acute Myeloid Leukemia Acute Myeloid Leukemia (AML) Fludarabine Fludarabine phosphate Etoposide Cytarabine Idarubicin Mitoxantrone Azacitidine Lenograstim
Open to people ages 18 years and up
Refractory to first-line AML therapy is defined as:
Untreated first hematologic relapse is defined as:
Be of non-child bearing potential:
Or, if of childbearing potential,
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02421939.
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