CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 276 enrolled
Drug / intervention
Gilteritinib +5 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/NCT03182244
NCT03182244Phase 3Active
CompareCT.gov

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 Inc·interventional·Posted Jun 9, 2017·Updated May 5, 2026

In Brief

A Phase 3 clinical trial evaluating Gilteritinib, Cytarabine, and 4 other interventions for AML With FLT3 Mutation. Active but no longer recruiting, targeting 276 participants across 49 sites in 5 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 AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as 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--
ConditionsAML With FLT3 Mutation
CountriesChina, Malaysia, Russia, Singapore, Thailand
Collaborators--

Timeline

Phase 3Active
2018201920202021202220232024202520262027
First PostedJun 9, 2017
Enrollment StartOct 25, 2017
Primary CompletionDec 25, 2023
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.1 years ago

Interventions

Gilteritinibdrug

Tablet administered orally once daily.

Cytarabinedrug

Once/twice daily Intravenously (IV)/subcutaneously (SC).

Mitoxantronedrug

Once daily IV injection.

Etoposidedrug

Once daily IV injection.

G-CSFdrug

Once daily IV/SC injection.

Fludarabinedrug

Once daily IV injection.