Table 1.
Baseline Characteristics of Patients (Intent‐to‐Treat Population)
| Characteristic | InO (n = 164) | SoC (n = 162) |
|---|---|---|
| Age, median (range), y | 46.5 (18‐78) | 47.5 (18‐79) |
| Age, No. (%) | ||
| <55 y | 104 (63.4) | 103 (63.6) |
| ≥55 y | 60 (36.6) | 59 (36.4) |
| Male sex, No. (%) | 91 (55.5) | 102 (63.0) |
| Race, No. (%) | ||
| White | 112 (68.3) | 120 (74.1) |
| Black | 4 (2.4) | 3 (1.9) |
| Asian | 31 (18.9) | 24 (14.8) |
| Missing | 17 (10.4) | 15 (9.3) |
| ECOG performance status, No. (%) | ||
| 0 | 62 (37.8) | 61 (37.7) |
| 1 | 81 (49.4) | 80 (49.4) |
| 2 | 21 (12.8) | 20 (12.3) |
| Missing | 0 (0) | 1 (0.6) |
| Salvage status, No. (%) | ||
| 1 | 111 (67.7) | 102 (63.0) |
| 2 | 51 (31.1) | 59 (36.4) |
| Missing | 2 (1.2) | 1 (0.6) |
| Duration of first remission <12 mo, No. (%) | 96 (58.5) | 106 (65.4) |
| Response to previous induction regimen, No. (%) | ||
| Complete remission | 121 (73.8) | 112 (69.1) |
| Partial remission | 11 (6.7) | 10 (6.2) |
| Prior HSCT, No. (%) | 29 (17.7) | 32 (19.8) |
| WBC count, median (range), ×103 cells/mm3 | 4.1 (0.0‐47.4) | 4.0 (0.1‐68.8) |
| Peripheral blast count, median (range), cells/μL | 107.6 (0‐42,660) | 30 (0‐43,331) |
| No circulating blasts, No. (%) | 71 (43.3) | 74 (45.7) |
| Bone marrow blasts, No. (%) | ||
| <50% | 53 (32.3) | 48 (29.6) |
| ≥50% | 109 (66.5) | 113 (69.8) |
| Missing | 2 (1.2) | 1 (0.6) |
| CD22 expression on ALL blasts, No. (%) | ||
| ≥90% | 107 (65.2) | 93 (57.4) |
| ≥70 but <90% | 30 (18.3) | 18 (11.1) |
| <70% | 5 (3.0) | 18 (11.1) |
| Missing | 22 (13.4) | 33 (20.4) |
| Baseline cytogenetics, No. (%) | ||
| Normal | 46 (28.0) | 42 (25.9) |
| ≥20 metaphases analyzed | 35 (21.3) | 34 (21.0) |
| Ph+ | 22 (13.4) | 27 (16.7) |
| t(4;11) | 6 (3.7) | 8 (4.9) |
| Complex | 28 (17.1) | 22 (13.6) |
| Del (9p) | 2 (1.2) | 3 (1.9) |
| Hyperdiploidy | 7 (4.3) | 2 (1.2) |
| Other abnormalities | 33 (20.1) | 36 (22.2) |
| Unknown/missing | 20 (12.2) | 22 (13.6) |
Abbreviations: ALL, acute lymphoblastic leukemia; ECOG, Eastern Cooperative Oncology Group; HSCT, hematopoietic stem cell transplantation; InO, inotuzumab ozogamicin; Ph+, Philadelphia chromosome–positive; SoC, standard of care (intensive chemotherapy); WBC, white blood cell.