Table 10.
Blinatumomab pediatric leukemia trials in http://www.clinicaltrials.gov
| Number | Abbreviated title | NCT number | Age | Sponsor |
|---|---|---|---|---|
| 1 | Risk-stratified randomized trial of blinatumomab in first relapse of childhood B-ALL | 02101853 | 1–30 years | NCI |
| 2 | Single-arm MC trial preceded by dose evaluation to investigate the E, S, and T of blinatumomab R/R B-precursor ALL | 01471782 | ≤17 years | Amgen Pharma |
| 3 | Phase III trial to investigate the E, S, and T of blinatumomab as consolidation therapy vs conventional consolidation CT HR first relapse B-precursor ALL | 02393859 | ≤17 years | Amgen Pharma |
| 4 | OL MC expanded access protocol for R/R B-precursor ALL | 02187354 | ≤17 years | Amgen Pharma |
Notes: The search term “blinatumomab leukemia children” resulted in five hits. However, study NCT02003222 was in ALL patients of 30–70 years. This study was not entered into this table.
Abbreviations: NCT, National Clinical Trial; ALL, acute lymphoblastic leukemia; NCI, National Cancer Institute; MC, multicenter; E, efficacy; S, safety; T, tolerability; R/R, relapsed or refractory; CT, chemotherapy; HR, high-risk; OL, open-label.