A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
← catalyst calendarNCT04521231 · readout in 462 d
Sponsored by Amgen (industry) · AMGN — their whole pipeline →. With BeOne Medicines.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
181actual
Sites
109
Countries
Argentina, Australia, Austria +17
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 | 2021-01-04 | actual | When the study began enrolling |
| Primary completion | 2027-11-24 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-05-25 | estimated | The whole study's end, after follow-up |
| First posted | 2020-08-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- B Cell Precursor Acute Lymphoblastic Leukemia
Intervention
- Drug: Blinatumomab — also filed as AMG 103
Primary outcomes
what the primary-completion date above is the date OFDose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)
measured Up to 29 days
Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
measured Up to approximately 28 weeks
Dose Escalation Phase: Number of participants who experience one or more serious TEAEs
measured Up to approximately 28 weeks
Dose Escalation Phase: Number of participants who experience one or more treatment-related TEAEs
measured Up to approximately 28 weeks
Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) of Interest (AEIs)
measured Up to approximately 28 weeks
Dose Expansion and Phase 2 Ph-IIR cohort: Number of participants who achieve complete remission (CR) / complete remission with partial hematological recovery (CRh)
measured Up to 10 weeks
Phase 2 Ph-IIC cohort: Maximum concentration (Cmax) of blinatumomab SC1 and SC2
measured Up to approximately 4 weeks
Phase 2 Ph-IIC cohort: Average concentration (Cavg) of blinatumomab SC1 and SC2
measured Up to approximately 4 weeks
Phase 2 Ph-IIC cohort: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2
measured Up to approximately 4 weeks
Phase 2 Ph-IIC cohort: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2
measured Up to approximately 4 weeks
Phase 2 Ph-IIM cohort: Number of participants who achieve CR with MRD-negative response
measured Up to 10 weeks
Publications
- PMID 38317420 — cited as background
- PMID 40532723 — cited as background
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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