Table 2.
Additional information from blinatumomab clinical trials.
| Patient population, phase | Blinatumomab dose (µg/m2/day) | Severe adverse events | Comment | Reference, ClinicalTrials.gov identifier |
|---|---|---|---|---|
| Adult MRD of B-precursor ALL, phase II | 15 | Lymphopenia, leukopenia, infections | Two relapses occurred in immunoprivileged sites | Topp et al. [2011, 2012], NCT00560794 |
| Adult MRD of B-precursor ALL, phase II | 15 | Pyrexia, tremor, aphasia, encephalopathy, overdose | 98% of patients had response in first cycle | Goekbuget et al. [2014], NCT01207388 |
| Adult R/R B-precursor ALL, phase II | 5, 15, 30 | Leukopenia, thrombocytopenia, infections, nervous system/psychiatric disorders | Stepwise dosing plus prophase treatment designed to reduce risk of CRS | Topp et al. [2014], NCT01209286 |
| Adult Ph- R/R B-precursor ALL, phase II | 9→28 | Febrile neutropenia, neutropenia, anemia | Dexamethasone prophase treatment did not affect response. Nearly half who interrupted treatment still achieved subsequent CR/CRh |
Topp et al. [2015a], NCT01466179 |
| Pediatric and adolescent R/R B-precursor ALL, phase I | 5, 15, 30 | N/A | Pharmacokinetic parameters similar to adults. | Von Stackelberg et al. [2014], NCT01471782 |
| Pediatric and adolescent R/R B-precursor ALL, phase II | 5→15 | Anemia, pyrexia, increased alanine and aspartate aminotransferases, febrile neutropenia | 3/39 patients had CRS | Gore et al. [2014], NCT01471782 |
ALL, acute lymphoblastic leukemia; CR, complete remission; CRh, complete remission with partial hematologic recovery; CRS, cytokine-release syndrome; MRD, minimal residual disease; Ph, Philadelphia chromosome; R/R, relapsed/refractory.