Table 1.
Detailed description of cohort
| Intervention | Standard of Care | Natural History1 | p-value2 | |||||
|---|---|---|---|---|---|---|---|---|
| N | (%) | N | (%) | N | (%) | |||
| Total Cohort | 19 | (100%) | 10 | (100%) | 20 | (100%) | – | |
| Age, Year | Median (range) | 15.2 | (11–19) | 14.6 | (11–18) | 13.8 | (10–19) | 0.4243 |
| <15 years | 10 | (53%) | 3 | (30%) | 7 | (35%) | 0.394 | |
| ≥15 years | 9 | (47%) | 7 | (70%) | 13 | (65%) | ||
| Sex | Male | 13 | (68%) | 6 | (60%) | 11 | (55%) | 0.688 |
| Ethnicity | Hispanic | 17 | (89%) | 8 | (80%) | 16 | (80%) | 0.688 |
| Not-Hispanic | 2 | (11%) | 2 | (20%) | 4 | (20%) | ||
| Phenotype | B-ALL | 15 | (79%) | 10 | (100%) | 15 | (75%) | 0.231 |
| T-ALL* | 4 | (21%) | 0 | (0%) | 5 | (25%) | ||
| Tanner Stage | 1 | 1 | (6%) | 1 | (10%) | 5 | (25%) | 0.198 |
| 2 | 1 | (6%) | 1 | (10%) | 2 | (25%) | ||
| 3 | 0 | (0%) | 0 | (0%) | 3 | (10%) | ||
| 4 | 5 | (28%) | 3 | (30%) | 1 | (5%) | ||
| 5 | 11 | (61%) | 5 | (50%) | 9 | (45%) | ||
| BMI stratum | <85% | 10 | (53%) | 5 | (50%) | 14 | (70%) | 0.779 |
| 85 to <95% | 4 | (21%) | 2 | (20%) | 3 | (15%) | ||
| ≥95% | 5 | (26%) | 3 | (30%) | 3 | (15%) | ||
| EOI Vitamin D4 | Sufficient | 8 | (42%) | 4 | (40%) | 10 | (50%) | 0.906 |
| Insufficient | 11 | (53%) | 6 | (60%) | 9 | (45%) | ||
| Deficient | 1 | (5%) | 0 | (0%) | 1 | (5%) | ||
1
Includes non-adherent subjects enrolled prior to open-label amendment (n=16) and those not eligible for randomization (n=4), excludes subjects who did not reach time of randomization (n=2).
2
pearson Chi-square unless otherwise specified.
3
Analysis of variance.
4
Vitamin D category at time of randomization [end of Induction] per Institute of Medicine thresholds.
*
One T-ALL patient was treated on the AALL0434 study without high-dose methotrexate. B-ALL = B-precursor ALL; T-ALL = T-cell ALL; BMI = Body Mass Index, EOI = End of Induction