Trial | Study design | Patient population | Enrolled patients | Primary endpoint | Results | Reference |
TOWER (NCT02013167) | Prospective, randomized phase III | Adults with Ph− RR B-ALL | 405 | OS | Median OS 7.7 months in blinatumomab group versus 4.0 months in the chemotherapy group (HR 0.71; 95% CI, 0.55 to 0.93; p=0.01) | 20 |
ALCANTARA (NCT02000427) | Open-label-, single-arm phase II | Adults with Ph+ RR B-ALL | 45 | CR or CRh | CR or CRh rate 36% (95% CI, 22% to 51%) with 88% MRD− | 135 |
MT103-205 (NCT01471782) | Phase I/II | Children with RR B-ALL | 93 total (49 phase I) (44 phase II) | MTD (phase I) CR (phase II) | CR rate 39% (95% CI, 27% to 51%) with 52% MRD− | 136 |
BLAST (NCT01207388) | Open-label, single-arm phase II | Adults with B-ALL in first or later hematological CR and persistent or recurrent MRD ≥10−3 | 113 | Complete MRD response | 78% achieved MRD− | 32 |
B-ALL, B-cell acute lymphoblastic leukemia; CR, complete response; CRh, CR with partial hematologic recovery; FDA, Food and Drug Administration; MRD, minimal/measurable residual disease; MTD, maximum-tolerated dosage; OS, overall survival; Ph, Philadelphia chromosome; RR, relapsed/refractory.