Table 1.
Blinatumomab clinical trials.
| Patient population, phase | Number of patients | Remission rate (CR/CRh) | MRD-negative rate among responders | Survival (median follow up) | Salvaged to transplant | Reference, ClinicalTrials.gov identifier |
|---|---|---|---|---|---|---|
| Adult MRD of B-precursor ALL, phase II | 21 | N/A | 80% | RFS 65% (33 months) | 50% | Topp et al. [2011, 2012], NCT00560794 |
| Adult MRD of B-precursor ALL, phase II | 116 | N/A | 80% | N/A | N/A | Goekbuget et al. [2014], NCT01207388 |
| Adult R/R B-precursor ALL, phase I/II | 36 | 69% | 88% | OS 9.8 months (12.1 months); RFS 7.6 months (9.7 months) | 52% | Topp et al. [2014], NCT01209286 |
| Adult Ph- R/R B-precursor ALL, phase II | 189 | 43% | 82% | OS 6.1 months (9.8 months); RFS 5.9 months (8.9 months) | 40% | Topp et al. [2015a], NCT01466179 |
| Pediatric and adolescent R/R B-precursor ALL, phase I | 41 | 32% | 77% | OS 5.7 months; RFS 8.3 months (12.4 months) | 69% | Von Stackelberg et al. [2014], NCT01471782 |
| Pediatric and adolescent R/R B-precursor ALL, phase II | 39 | 31% | 42% | OS 4.3 months (6 months); RFS 5.6 months | 50% | Gore et al. [2014], NCT01471782 |
ALL, acute lymphoblastic leukemia; CR, complete remission; CRh, complete remission with partial hematologic recovery; MRD, minimal residual disease; OS, overall survival; Ph, Philadelphia chromosome; RFS, relapse-free survival; R/R, relapsed/refractory.