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
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 354
Summary
- Conditions
- Acute Myeloid Leukemia (AML)
- Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ent...
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.
Tracking Information
- NCT #
- NCT02927262
- Collaborators
- Not Provided
- Investigators
- Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.