CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
Gilteritinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02927262
NCT02927262Phase 2Completed
CompareCT.gov

A Phase 2 Multicenter, 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

Astellas Pharma Global Development, Inc.·interventional·Posted Oct 7, 2016·Updated Nov 26, 2024

In Brief

A Phase 2 clinical trial evaluating Gilteritinib and Placebo for Acute Myeloid Leukemia (AML) and Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation. Completed, enrolled 98 participants across 73 sites in 21 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
CountriesBrazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Serbia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 7, 2016
Enrollment StartJan 10, 2017
Primary CompletionMay 25, 2021
Study CompletionFeb 19, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.7 years ago

Interventions

Gilteritinibdrug

Oral tablet

Placebodrug

Oral tablet