CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 371 enrolled
Drug / intervention
gilteritinib +4 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/NCT02421939
NCT02421939Phase 3Completed
CompareCT.gov

A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Astellas Pharma Global Development, Inc.·interventional·Posted Apr 21, 2015·Updated Dec 4, 2025

In Brief

A Phase 3 clinical trial evaluating gilteritinib, LoDAC (Low Dose Cytarabine), and 3 other interventions for Leukemia, Acute Myeloid (AML). Completed, enrolled 371 participants across 126 sites in 14 countries.

Detailed Summary

The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and determined the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study also determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Acute Myeloid (AML)
CountriesBelgium, Canada, France, Germany, Israel, Italy, Japan, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 21, 2015
Enrollment StartOct 20, 2015
Primary CompletionSep 17, 2018
Study CompletionFeb 25, 2025
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago

Interventions

gilteritinibdrug

tablet, oral

LoDAC (Low Dose Cytarabine)drug

subcutaneous (SC) or intravenous (IV) injection

Azacitidinedrug

SC or IV injection

MEC (Mitoxantrone, Etoposide, Cytarabine)drug

IV injection

FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)drug

SC (G-CSF) and IV (Fludarabine, Cytarabine, Idarubicin) injection