A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
276actual
Sites
49
Countries
China, Malaysia, Russia +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-10-25 | actual | When the study began enrolling |
| Primary completion | 2023-12-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2017-06-09 | actual | When this record first appeared on the registry |
| Results posted | 2025-01-14 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- AML With FLT3 Mutation
Interventions
- Drug: Gilteritinib — also filed as ASP2215
- Drug: Cytarabine
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: G-CSF
- Drug: Fludarabine
Primary outcome
what the primary-completion date above is the date OFOverall Survival (OS)
measured From the date of randomization up to the date of death (up to approximatley 74 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-06-05 · 1.2 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-02-22 · 850 KB · SAP_003.pdf
Publications
- PMID 40063243 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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