NCT03730012

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)

Phase 1/2 Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab. This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed.

Detailed description

This study was planned to have 2 phases: Phase 1: The phase 1 portion of this study was to establish the recommended phase 2 dose (RP2D) of gilteritinib given in combination with atezolizumab. Phase 2: The phase 2 portion of the study was to treat participants with gilteritinib and atezolizumab at the RP2D and was to be enrolled in two stages. The first stage was to evaluate the remission rate and if a minimum rate was to be achieved, a second stage of enrollment was to be continued.

Conditions

• Acute Myeloid Leukemia (AML)
• Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

Interventions

Type	Name	Description
DRUG	gilteritinib	Oral tablet
DRUG	atezolizumab	Intravenous infusion

Timeline

• Start date: 2019-06-19
• Primary completion: 2021-05-14
• Completion: 2021-06-15
• First posted: 2018-11-05
• Last updated: 2024-11-29
• Results posted: 2022-06-24

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study