Table 2.
Ongoing or planned clinical trials with blinatumomab in R/R B-cell precursor ALL
| Phase | ClinicalTrials.gov identifier (acronym) | Title | Number of patients | Study design |
|---|---|---|---|---|
| R/R ALL, adults | ||||
| I/II | NCT02412306a | Study of blinatumomab in Japanese subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia | 100 | Open-label, single arm |
| I/II | NCT03160079b | Blinatumomab and pembrolizumab for adults with relapsed/refractory B-cell acute lymphoblastic leukemia with high marrow Lymphoblasts | 24 | Open-label, single arm |
| II | NCT03518112c | Low-intensity chemotherapy and blinatumomab in patients with Philadelphia chromosome negative relapsed/refractory acute lymphoblastic leukemia (ALL) | 44 | Open-label, single arm |
| III | NCT03476239d | Efficacy and safety of the BiTE antibody blinatumomab in Chinese adult subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | 120 | Open-label, single arm |
| R/R ALL, pediatrics | ||||
| III | NCT02101853e | Risk-stratified randomized phase III testing of blinatumomab in first relapse of childhood B-lymphoblastic leukemia (B-ALL) | 598 (estimated) Age 1–30 years |
Open-label, randomized, controlled, parallel assignment |
| III | NCT02393859d | Phase 3 trial to investigate the efficacy, safety, and tolerability of blinatumomab as consolidation therapy versus conventional consolidation chemotherapy in pediatric subjects with HR first relapse B-precursor ALL | 202 (estimated) Age < 18 years |
Open label, randomized, controlled, parallel assignment |
| IV | NCT02187354d (RIALTO) | An open-label, multi-center, expanded access protocol of blinatumomab for the treatment of pediatric and adolescent subjects with relapsed and/or refractory B-precursor acute lymphoblastic leukemia (ALL) | 80 (ongoing) Age < 18 years |
Open-label, single-arm, expanded access |
ALL acute lymphoblastic leukemia, Ph Philadelphia chromosome, R/R relapsed/refractory
aAmgen-sponsored study; collaborator: Amgen Astellas Biopharma K.K.
bMatthew Wieduwilt-sponsored study; collaborators: Merck Sharp & Dohme Corp. and Amgen
cM.D. Anderson Cancer Center-sponsored study; collaborator: Amgen
dAmgen-sponsored study
eNational Cancer Institute (NCI)-sponsored study