Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
← catalyst calendarNCT04994717 · readout in 1,115 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
303actual
Sites
192
Countries
Australia, Austria, Belgium +29
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 | 2021-11-02 | actual | When the study began enrolling |
| Primary completion | 2029-09-07 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2021-08-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Interventions
- Drug: Blinatumomab — also filed as Blincyto®
- Drug: Low-intensity chemotherapy regimen
- Drug: SOC chemotherapy regimen
Primary outcomes
what the primary-completion date above is the date OFSafety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
measured Up to approximately 5 years
Phase 3: Event-free Survival (EFS)
measured Up to approximately 5 years
Phase 3: Overall Survival (OS)
measured Up to approximately 5 years
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