Table 2.
Description of cohort
| Characteristic | IDEAL trial, no. (%) or mean ± SD | Historical control, no. (%) or mean ± SD | P |
|---|---|---|---|
| Total | 40 (100) | 80 (100) | n/a |
| Age, y | |||
| Mean ± SD | 15.0 ± 3.0 | 14.7 ± 2.5 | .72 |
| 10-14.9 | 19 (48) | 46 (58) | .34 |
| ≥15 | 21 (52) | 34 (42) | |
| Sex | |||
| Female | 16 (40) | 37 (46) | .56 |
| Male | 24 (60) | 43 (54) | |
| Ethnicity | |||
| Not Hispanic | 8 (20) | 14 (18) | .002 |
| Hispanic | 26 (65) | 66 (83) | |
| Not reported | 6 (15) | 0 (0) | |
| WBC, ×103/μL | |||
| Mean ± SD | 56 ± 117 | 50 ± 93 | .54 |
| <50 | 31 (77) | 57 (71) | .52 |
| ≥50 | 9 (23) | 23 (29) | |
| Cytogenetics* | |||
| Neutral | 18 (45) | 61 (76) | <.001 |
| Favorable | 3 (7) | 10 (13) | |
| Adverse | 19 (48) | 8 (10) | |
| Unknown | 0 (0) | 1 (1) | |
| CNS disease† | |||
| CNS1 | 26 (65) | 62 (78) | .32 |
| CNS2 | 12 (30) | 16 (20) | |
| CNS3 | 2 (5) | 2 (2) | |
| BMI category | |||
| Lean | 14 (35) | 45 (56) | .09 |
| Overweight | 6 (15) | 9 (11) | |
| Obese | 20 (50) | 26 (33) | |
| BMI percentile | 79.5 ± 27.3 | 67.2 ± 32.8 | .03 |
| Body composition‡ | |||
| Fat mass, kg | 25.2 ± 14.1 | 18.4 ± 11.3 | .04 |
| % Fat | 32.7 ± 9.6 | 27.8 ± 9.0 | .02 |
| Lean mass, kg | 45.3 ± 14.7 | 39.5 ± 12.5 | .11 |
| % Lean | 64.4 ± 9.2 | 68.9 ± 8.5 | .02 |
CNS, central nervous system; CNS1, no blast cells in cerebrospinal fluid (CSF); CNS2, <5 WBC/μL CSF with blast cells; CNS3, ≥5 WBC/μL CSF with blast cells or signs of CNS involvement; n/a, not applicable; SD, standard deviation.
*
Cytogenetics classified using COG risk stratification; see “Methods.”
†
Involvement of CNS per COG criteria.
‡
Body composition assessed by DXA in subset of historical control.