Table 2.
Patient characteristics by randomization arm
| Total patients | Arm ASP-5000 | Arm ASP-10000 | р |
|---|---|---|---|
| n = 334 | n = 354 | ||
| Gender | |||
| Boys | 181 | 192 | 0.949 |
| Girls | 153 | 162 | |
| Age (years) | |||
| ≥ 1–< 5 | 161 | 189 | 0.370 |
| ≥ 5–<10 | 93 | 92 | |
| ≥ 10 | 80 | 73 | |
| Initial WBC count | |||
| < 10,000/µl | 210 | 227 | 0.271 |
| ≥ 10,000–< 30,000/µl | 102 | 94 | |
| ≥ 30,000–< 50,000/µl | 22 | 33 | |
| Spleen enlargement below left costal margin (cm) | |||
| < 4 | 258 | 256 | 0.162 |
| ≥ 4 | 76 | 98 | |
| Geneticsa | |||
| t(12;21) | 29 | 24 | 0.491 |
| Response to treatment on day 8b | |||
| < 1000 leukemic blasts/µl PB | 318 | 331 | 0.473 |
| ≥ 1000 leukemic blasts/µl PB | 9 | 14 | |
| Response to treatment on day 15c | |||
| < 10% leukemic blasts in BM | 272 | 285 | 0.790 |
| ≥ 10–< 25% leukemic blasts in BM | 40 | 39 | |
| ≥ 25% leukemic blasts in BM | 19 | 24 | |
| Induction therapy | |||
| Dexamethasone 6 mg/m2 | 168 | 176 | 0.874 |
| Methylprednisolone 60 mg/m2 | 163 | 177 | |
ASP asparaginase, BM bone marrow, IM intramuscular, PB peripheral blood, WBC white blood cell count
aInvestigation of relevant translocations performed in 506 patients (n = 251 in the arm ASP-5000, n = 255 in the arm ASP-10000)
bTreatment response on day 8 was documented for 672 patients (327 patients in the arm ASP-5000, 345 patients in the arm ASP-10000)
cTreatment response on day 15 was documented for 679 patients (331 patients in the arm ASP-5000, 348 patients in the arm ASP-10000)