A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
← catalyst calendarNCT07134088 · readout in 839 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
104estimated
Sites
5
Countries
Japan, United States
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 | 2025-12-08 | actual | When the study began enrolling |
| Primary completion | 2028-12-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-06-18 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
- Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
Intervention
- Drug: Blinatumomab
Primary outcomes
what the primary-completion date above is the date OFPhase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
measured Up to 29 days
Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
measured Up to approximately 7 months
Phase 1b: Number of Participants who Experienced Serious TEAEs
measured Up to 2 years and 7 months
Phase 1b: Number of Participants who Experienced Treatment-related TEAEs
measured Up to approximately 7 months
Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)
measured Up to approximately 7 months
Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 Cycles
measured Up to 70 days
Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles
measured Up to 70 days
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