Patient characteristics, comparing those with and without PCR and/or MLPA data to the main trial population
| . | PCR sample, N = 498 . | No PCR sample, N = 157 . | P* . | MLPA sample, N = 436 . | No MLPA sample, N = 219 . | P* . | All eligible UKALL14 B-cell patients, N = 655 . |
|---|---|---|---|---|---|---|---|
| Rituximab given, N (%) | 256 (51.4) | 71 (45.2) | 222 (50.9) | 105 (47.9) | 327 (49.9) | ||
| Median age (range), y | 46.0 (23-65) | 47.0 (22-65) | .11 | 45.0 (23-65) | 48.0 (22-65) | <.001 | 46.0 (22-65) |
| Age over 40 y at randomization group, N (%) | 315 (63.3) | 107 (68.2) | .26 | 264 (60.6) | 158 (72.1) | .003 | 422 (64.4) |
| Sex, N (%) | .71 | .89 | |||||
| Male† | 270 (54.2) | 88 (56.1) | 239 (54.8) | 119 (54.3) | 358 (54.7) | ||
| ECOG, score 0 N (%) | 304 (61.5) | 94 (61.0) | .91 | 266 (61.4) | 132 (61.4) | .99 | 398 (61.4) |
| Baseline WBC | 9.7 (0.11-889.6) | 4.7 (0.4-372) | <.001 | 10.7 (0.11-889.6) | 4.9 (0.4-372) | <.001 | 8.0 (0.11-889.6) |
| Genetic subgroup, N (%) | |||||||
| BCR-ABL1+ | 167 (33.5) | 31 (19.7) | .001 | 154 (35.3) | 44 (20.1) | <.001 | 198 (30.2) |
| Complex karyotype | 17 (3.4) | 4 (2.5) | NA | 14 (3.2) | 7 (3.2) | NA | 21 (3.2) |
| High hyperdiploid | 10 (2.0) | 3 (1.9) | NA | 9 (2.1) | 4 (1.8) | NA | 13 (2.0) |
| JAK-STAT lesions | 26 (5.2) | 8 (5.1) | NA | 26 (6.0) | 8 (3.7) | NA | 34 (5.2) |
| KMT2A other | 7 (1.4) | 2 (1.3) | NA | 6 (1.4) | 3 (1.4) | NA | 9 (1.4) |
| KMT2A-AFF1 | 42 (8.4) | 7 (4.5) | NA | 40 (9.2) | 9 (4.1) | NA | 49 (7.5) |
| Low hypodiploid/Near-triploid | 36 (7.2) | 17 (10.8) | NA | 3 (0.7) | 50 (22.8) | NA | 53 (8.1) |
| Other | 123 (24.7) | 49 (31.2) | NA | 123 (28.2) | 49 (22.4) | NA | 172 (26.3) |
| TCF3-PBX1 | 14 (2.8) | 0 | NA | 14 (3.2) | 0 | NA | 14 (2.1) |
| Failed or missing | 56 (11.2) | 36 (22.9) | 47 (10.8) | 45 (20.5) | 92 (14.0) | ||
| Baseline UKALL 14 risk, N (%) | .76 | .050 | |||||
| High risk‡ | 420 (84.3) | 126 (80.3) | 356 (81.7) | 190 (86.8) | 546 (83.4) | ||
| IKZF1 deleted by PCR, N (%) | 114 (22.9) | 106 (25.2) | 114 (22.9) | ||||
| IKZF1 deleted by MLPA, N (%) | 165 (39.3) | 170 (39.0) | 170 (39.0) |
| . | PCR sample, N = 498 . | No PCR sample, N = 157 . | P* . | MLPA sample, N = 436 . | No MLPA sample, N = 219 . | P* . | All eligible UKALL14 B-cell patients, N = 655 . |
|---|---|---|---|---|---|---|---|
| Rituximab given, N (%) | 256 (51.4) | 71 (45.2) | 222 (50.9) | 105 (47.9) | 327 (49.9) | ||
| Median age (range), y | 46.0 (23-65) | 47.0 (22-65) | .11 | 45.0 (23-65) | 48.0 (22-65) | <.001 | 46.0 (22-65) |
| Age over 40 y at randomization group, N (%) | 315 (63.3) | 107 (68.2) | .26 | 264 (60.6) | 158 (72.1) | .003 | 422 (64.4) |
| Sex, N (%) | .71 | .89 | |||||
| Male† | 270 (54.2) | 88 (56.1) | 239 (54.8) | 119 (54.3) | 358 (54.7) | ||
| ECOG, score 0 N (%) | 304 (61.5) | 94 (61.0) | .91 | 266 (61.4) | 132 (61.4) | .99 | 398 (61.4) |
| Baseline WBC | 9.7 (0.11-889.6) | 4.7 (0.4-372) | <.001 | 10.7 (0.11-889.6) | 4.9 (0.4-372) | <.001 | 8.0 (0.11-889.6) |
| Genetic subgroup, N (%) | |||||||
| BCR-ABL1+ | 167 (33.5) | 31 (19.7) | .001 | 154 (35.3) | 44 (20.1) | <.001 | 198 (30.2) |
| Complex karyotype | 17 (3.4) | 4 (2.5) | NA | 14 (3.2) | 7 (3.2) | NA | 21 (3.2) |
| High hyperdiploid | 10 (2.0) | 3 (1.9) | NA | 9 (2.1) | 4 (1.8) | NA | 13 (2.0) |
| JAK-STAT lesions | 26 (5.2) | 8 (5.1) | NA | 26 (6.0) | 8 (3.7) | NA | 34 (5.2) |
| KMT2A other | 7 (1.4) | 2 (1.3) | NA | 6 (1.4) | 3 (1.4) | NA | 9 (1.4) |
| KMT2A-AFF1 | 42 (8.4) | 7 (4.5) | NA | 40 (9.2) | 9 (4.1) | NA | 49 (7.5) |
| Low hypodiploid/Near-triploid | 36 (7.2) | 17 (10.8) | NA | 3 (0.7) | 50 (22.8) | NA | 53 (8.1) |
| Other | 123 (24.7) | 49 (31.2) | NA | 123 (28.2) | 49 (22.4) | NA | 172 (26.3) |
| TCF3-PBX1 | 14 (2.8) | 0 | NA | 14 (3.2) | 0 | NA | 14 (2.1) |
| Failed or missing | 56 (11.2) | 36 (22.9) | 47 (10.8) | 45 (20.5) | 92 (14.0) | ||
| Baseline UKALL 14 risk, N (%) | .76 | .050 | |||||
| High risk‡ | 420 (84.3) | 126 (80.3) | 356 (81.7) | 190 (86.8) | 546 (83.4) | ||
| IKZF1 deleted by PCR, N (%) | 114 (22.9) | 106 (25.2) | 114 (22.9) | ||||
| IKZF1 deleted by MLPA, N (%) | 165 (39.3) | 170 (39.0) | 170 (39.0) |
ECOG, Eastern Cooperative Oncology Group; NA, P values not provided where numbers too low for meaningful comparisons (P values for BCR-ABL status compare positive vs negative).
χ2 unless otherwise specified (missing values excluded).
There was 1 patient who was intersex (genetically male but identified as female: they have been excluded from all comparisons using sex).
For the purposes of the trial, patients missing risk factor data (but no high-risk factors in the data available) were assumed to be standard risk. For any comparisons, these patients were excluded (?5% of all B-cell patients).