Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)
← catalyst calendarSponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
6actual
Sites
6
Country
Japan
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 | 2025-01-08 | actual | When the study began enrolling |
| Primary completion | 2025-07-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-04 | actual | The whole study's end, after follow-up |
| First posted | 2024-10-18 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- B-precursor Acute Lymphoblastic Leukemia
Intervention
- Drug: Blinatumomab — also filed as Blincyto®
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
measured From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days
Number of Participants Experiencing Adverse Events of Interest (EOI)
measured From first dose until 33 days after last dose of trial; median (min,max) overall duration was 107.4 (41.2, 190.2) days
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-06-05 · 3.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-09-26 · 440 KB · SAP_001.pdf
Permalink · AMGN's whole pipeline · Catalyst calendar · Every registered study · What changed