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A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
||A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission
Acute Myeloid Leukemia, Leukemia
||Kellie Sprague, MD
||Elizabeth Kendricken, RN
The purpose of the study is to see if a medicine called gilteritinib (ASP2215) is both effective and safe as maintenance treatment (treatment you will receive to maintain the response achieved during the first course of your treatment) for AML patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.
- Diagnosed with AML and in first complete remission with mutations in the FLT3 gene
- Will not be receiving a bone marrow transplant
- Otherwise normal organ function
- No pregnant or nursing women
- No complicating diseases or disorders including but not limited to: prior allogenic transplant, active CNS leukemia, HIV positive, active acute or chronic infections, severe heart disease, or cancer requiring treatment within the last 5 years.
Subjects in CR1 will be approached for this study after induction/consolidation therapy is complete and a decision not to proceed with transplantation is made or a suitable donor could not be identified. Subjects will be randomized in a 2:1 ratio to receive gilteritinib or placebo. Subjects will enter the screening period up to 14 days prior to the start of treatment. Subjects will be administered treatment over continuous 28-day cycles. After treatment discontinuation, subjects will have a 30-day follow-up visit for safety, after which the subjects will enter the long-term follow up period for collection of subsequent AML treatment, remission status, and survival (cause of death and date of death). Gilteritinib or placebo will be given daily for up to 2 years. Subjects will be followed for up to 3 years after the last treatment visit, or until 80% of the subjects have an RFS event, whichever comes first. Study drug will not be provided during the follow-up period.