A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 61
Summary
- Conditions
- Acute Myeloid Leukemia (AML)
- Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study will have 2 phases. Phase 1: The phase 1 portion of this study is to establish the recommended phase 2 dose (RP2D) of gilteritinib given in combination with atezolizumab. Phase 2: The phase 2 portion of the study will treat patients with gilteritinib and atezolizumab at the RP2D and will ...
This study will have 2 phases. Phase 1: The phase 1 portion of this study is to establish the recommended phase 2 dose (RP2D) of gilteritinib given in combination with atezolizumab. Phase 2: The phase 2 portion of the study will treat patients with gilteritinib and atezolizumab at the RP2D and will enroll in two stages. The first stage will evaluate the remission rate and if a minimum rate is achieved, a second stage of enrollment will continue.
Tracking Information
- NCT #
- NCT03730012
- Collaborators
- Not Provided
- Investigators
- Study Director: Executive Medical Director Astellas Pharma Global Development
Get Well Soon