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A phase 3 trial of Gilteritinib, Cytarabine, Mitoxantrone, Etoposide and Fludarabine in acute myeloid leukaemia, run by Astellas Pharma Inc, now completed.
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 is a phase 3 interventional study registered as NCT03182244 by Astellas Pharma Inc, with 276 participants enrolled, started 2017-10-25 and reached its primary completion in 2023-12-25. Interventions recorded: Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF and Fludarabine. Results have been posted on the registry.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
276 enrolled.
95% CI 8.8 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2025-01-14), not from a publication · 95% CI 4.1 to 8.1
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall Survival (OS)primary | Gilteritinib | 137 | 10.3 months | 0.612 (0.451 to 0.832) | 0.00152 | link |
| Salvage Chemotherapy | 139 | 5.4 months |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares FLT3-mutated acute myeloid leukaemia, Fludarabine, Cytarabine, Etoposide and the tag pipeline.
Shares Mitoxantrone, Fludarabine, Cytarabine, Acute myeloid leukaemia and the tag pipeline.
Shares Gilteritinib, Mitoxantrone, Cytarabine, Etoposide and the tag pipeline.
Shares Cytarabine, Etoposide, Acute myeloid leukaemia and the tag pipeline.
Shares Mitoxantrone, Cytarabine, Etoposide, Acute myeloid leukaemia and the tag pipeline.
Shares Gilteritinib, Astellas, Acute myeloid leukaemia and the tag pipeline.
Shares Mitoxantrone, Cytarabine, Etoposide and the tag pipeline.
Shares Mitoxantrone, Cytarabine, Etoposide and the tag pipeline.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
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