Trials / Recruiting
RecruitingNCT07134088
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 28 Days – 4383 Days
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
Conditions
- Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
- Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Blinatumomab | Blinatumomab will be administered as a SC injection for up to 5 cycles (each cycle will be 35 days). |
Timeline
- Start date
- 2025-12-08
- Primary completion
- 2028-12-05
- Completion
- 2030-06-18
- First posted
- 2025-08-21
- Last updated
- 2026-03-30
Locations
3 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07134088. Inclusion in this directory is not an endorsement.