Table 1.
Baseline demographics and clinical characteristics
| Blinatumomab 9‐28 µg/day | ||
|---|---|---|
|
Phase 1b N = 5 |
Phase 2 N = 21 |
|
| Sex, n (%) | ||
| Male | 1 (20) | 9 (43) |
| Female | 4 (80) | 12 (57) |
| Age, median (range), years | 58 (23‐75) | 43 (18‐55) |
| ECOG PS, n (%) | ||
| 0 | 1 (20) | 11 (52) |
| 1 | 3 (60) | 9 (43) |
| 2 | 1 (20) | 1 (5) |
| Bone marrow blasts, n (%) | ||
| ≤5% | 0 (0.0) | 0 (0.0) |
| >5% to <10% | 0 (0.0) | 2 (10) |
| 10% to <50% | 2 (40) | 6 (29) |
| ≥50% | 3 (60) | 13 (62) |
| B‐ALL subtype, n (%) | ||
| Pro–B‐ALL | 1 (20) | 2 (10) |
| Pre–B‐ALL | 1 (20) | 5 (24) |
| C‐ALL | 3 (60) | 10 (48) |
| B‐ALL with recurrent genetic abnormality | 0 (0) | 4 (19) |
| Extramedullary disease, n (%) | 1 (20) | 2 (10) |
| Prior HSCT, n (%) | 4 (80) | 9 (43) |
| 1 | 2 (40) | 9 (43) |
| 2 | 2 (40) | 0 (0) |
| Number of relapses, n (%) | ||
| 1 | 2 (40) | 13 (62) |
| 2 | 0 (0) | 4 (19) |
| >2 | 3 (60) | 0 (0) |
| Number of salvage therapies, n (%) | ||
| 0 | 1 (20) | 7 (33) |
| 1 | 1 (20) | 7 (33) |
| 2 | 2 (40) | 4 (19) |
| >2 | 1 (20) | 3 (14) |
Abbreviations: ALL, acute lymphoblastic leukemia; HSCT, hematopoietic stem cell transplantation.