Last updated on July 2020

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

Brief description of study

The purpose of this study is to compare relapse-free survival (RFS) between subjects with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who are randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.

Detailed Study Description

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. Gilteritinib or placebo will be given daily for up to 2 years. 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). Subjects will be contacted every 3 months until final database lock. Study drug will not be provided during the follow-up period.

Clinical Study Identifier: NCT02927262

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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