Table 1.
Baseline characteristics
| Standard of care (n=288) | Standard of care plus rituximab (n=289) | Total (n=577) | |||
|---|---|---|---|---|---|
| Age, years | 45 (35–54; 22–65) | 46 (33–55; 23–65) | 46 (34–54; 22–65) | ||
| Age group | |||||
| 40 years or younger at random assignment | 104 (36%) | 108 (37%) | 212 (37%) | ||
| 41 years or older at random assignment | 184 (64%) | 181 (63%) | 365 (63%) | ||
| Sex | |||||
| Male | 159 (55%) | 159 (55%) | 318 (55%) | ||
| Female | 128 (44%) | 130 (45%) | 258 (45%) | ||
| Intersex* | 1 (<1%) | 0 | 1 (<1%) | ||
| ECOG performance status | |||||
| 0–2 | 284 (99%) | 283 (98%) | 567 (98%) | ||
| 3–4 | 1 (<1%) | 4 (1%) | 5 (1%) | ||
| Missing data | 3 (1%) | 2 (1%) | 5 (1%) | ||
| Baseline white blood cell count, × 109 cells per L | 8·4 (0·1–583·1) | 7·9 (0·4–889·6) | 8·4 (0·1–583·1) | ||
| BCR-ABL1 and breakpoint | |||||
| BCR-ABL1-positive | 86 (30%) | 86 (30%) | 172 (30%) | ||
| p190 | 51 (18%) | 55 (19%) | 106 (18%) | ||
| p210 | 29 (10%) | 27 (9%) | 56 (10%) | ||
| Unknown breakpoint | 6 (2%) | 4 (1%) | 10 (2%) | ||
| Any UKALL14 cytogenetic risk factor | |||||
| Absent | 101 (35%) | 95 (33%) | 196 (34%) | ||
| Present | 143 (50%) | 140 (48%) | 283 (49%) | ||
| Missing data | 44 (15%) | 54 (19%) | 98 (17%) | ||
| Genetic subtype | |||||
| Complex karyotype | 11 (4%) | 6 (2%) | 17 (3%) | ||
| High hyperdiploid | 6 (2%) | 6 (2%) | 12 (2%) | ||
| JAK-STAT | 15 (5%) | 15 (5%) | 30 (5%) | ||
| KMT2A other | 4 (1%) | 2 (1%) | 6 (1%) | ||
| KMT2A-AFF1 | 17 (6%) | 25 (9%) | 42 (7%) | ||
| Low hypodiploid or near-triploid | 27 (9%) | 22 (8%) | 49 (9%) | ||
| TCF3-PBX1 | 6 (2%) | 8 (3%) | 14 (2%) | ||
| Other | 81 (28%) | 77 (27%) | 158 (27%) | ||
| Test failed or missing | 35 (12%) | 42 (15%) | 77 (13%) | ||
| Baseline UKALL 14 risk† | |||||
| Standard risk | 36 (13%) | 40 (14%) | 76 (13%) | ||
| High risk | 241 (84%) | 234 (81%) | 475 (82%) | ||
| Assumed standard risk‡ | 11 (4%) | 15 (5%) | 26 (5%) | ||
| Baseline UKALL14 risk excluding age | |||||
| Standard risk | 81 (28%) | 83 (29%) | 164 (28%) | ||
| High risk | 170 (59%) | 158 (55%) | 328 (57%) | ||
| Assumed standard risk‡ | 37 (13%) | 48 (17%) | 85 (15%) | ||
Data are median (IQR; range), median (IQR), or n (%). ECOG=Eastern Cooperative Oncology Group.
*
Excluded from any analyses where sex is included.
†
High presenting white blood cell count, high risk cytogenetics (BCR-ABL1-positive, KMT2A/AFF1, low hypodiploidy or near triploidy, complex [more than abnormalities]) or age 41 years and older.
‡
Patients with no high-risk features, but missing cytogenetic data (treated as standard risk).