Pre-tisagenlecleucel demographic characteristics of patients with R/R CNS disease, non-CNS EM disease, and the remaining cohort with isolated BM disease
| Characteristic . | CNS disease . | P . | CNS disease . | Non-CNS EM . | BM-only disease . | P . | |
|---|---|---|---|---|---|---|---|
| iCNS (n = 23) . | CNS + BM (n = 17) . | iCNS + CNS + BM (n = 40) . | (n = 15) . | (n = 129) . | |||
| Age at CAR infusion, y | 11 (2-24) | 10 (<1-25) | .85 | 10 (<1-25) | 13 (2-26) | 13 (<1-26) | .087 |
| Sex (male/female) | 18/5 | 13/4 | 1.0 | 31/9 | 9/6 | 71/58 | .036 |
| Initial NCI risk stratification | .72 | .013 | |||||
| Low/standard | 11 | 5 | 16 | 4 | 23 | ||
| High/very high | 9 | 7 | 16 | 6 | 74 | ||
| Unknown | 3 | 5 | 8 | 5 | 32 | ||
| Initial cytogenetics risk | .70 | .3 | |||||
| Favorable/intermediate | 11 | 7 | 18 | 5 | 50 | ||
| Unfavorable | 7 | 3 | 10 | 3 | 53 | ||
| Unknown | 5 | 7 | 12 | 7 | 26 | ||
| CNS status at diagnosis | .510 | .17 | |||||
| CNS1 | 16 | 11 | 27 | 13 | 85 | ||
| CNS2 | 4 | 4 | 8 | 1 | 32 | ||
| CNS | 2 | 0 | 2 | 0 | 1 | ||
| Unknown | 1 | 2 | 3 | 1 | 11 | ||
| No. of relapses before CAR therapy | 1.0 | .003 | |||||
| 0 | 1 | 0 | 1 | 1 | 29 | ||
| ≥1 | 22 | 17 | 39 | 14 | 100 | ||
| No. of lines of treatment before CAR therapy | .69 | .07 | |||||
| 1 | 1 | 0 | 1 | 0 | 8 | ||
| 2 | 5 | 2 | 7 | 1 | 39 | ||
| 3 | 7 | 8 | 15 | 3 | 39 | ||
| >4 | 10 | 7 | 17 | 11 | 43 | ||
| Prior SCT | 0 | 0 | 1.0 | 0 | 1 | 10 | .16 |
| Previous CRT/CSI | 3 | 2 | 1.0 | 5 | 3 | 6 | .037 |
| Time from diagnosis to CAR infusion, mo | 45 (4-135) | 52 (5-94) | .76 | 51 (4-135) | 50 (4-171) | 27 (3-164) | .01 |
| Time from relapse to CAR infusion, mo | 3 (2-19) | 2 (1-13) | .50 | 3 (1-19) | 3 (1-12) | 3 (0-12) | .10 |
| Prophylactic levetiracetam | 1.0 | .13 | |||||
| Yes | 16 | 11 | 27 | 6 | 67 | ||
| No | 7 | 6 | 13 | 9 | 60 | ||
| Unknown | 0 | 0 | 0 | 0 | 2 | ||
| Characteristic . | CNS disease . | P . | CNS disease . | Non-CNS EM . | BM-only disease . | P . | |
|---|---|---|---|---|---|---|---|
| iCNS (n = 23) . | CNS + BM (n = 17) . | iCNS + CNS + BM (n = 40) . | (n = 15) . | (n = 129) . | |||
| Age at CAR infusion, y | 11 (2-24) | 10 (<1-25) | .85 | 10 (<1-25) | 13 (2-26) | 13 (<1-26) | .087 |
| Sex (male/female) | 18/5 | 13/4 | 1.0 | 31/9 | 9/6 | 71/58 | .036 |
| Initial NCI risk stratification | .72 | .013 | |||||
| Low/standard | 11 | 5 | 16 | 4 | 23 | ||
| High/very high | 9 | 7 | 16 | 6 | 74 | ||
| Unknown | 3 | 5 | 8 | 5 | 32 | ||
| Initial cytogenetics risk | .70 | .3 | |||||
| Favorable/intermediate | 11 | 7 | 18 | 5 | 50 | ||
| Unfavorable | 7 | 3 | 10 | 3 | 53 | ||
| Unknown | 5 | 7 | 12 | 7 | 26 | ||
| CNS status at diagnosis | .510 | .17 | |||||
| CNS1 | 16 | 11 | 27 | 13 | 85 | ||
| CNS2 | 4 | 4 | 8 | 1 | 32 | ||
| CNS | 2 | 0 | 2 | 0 | 1 | ||
| Unknown | 1 | 2 | 3 | 1 | 11 | ||
| No. of relapses before CAR therapy | 1.0 | .003 | |||||
| 0 | 1 | 0 | 1 | 1 | 29 | ||
| ≥1 | 22 | 17 | 39 | 14 | 100 | ||
| No. of lines of treatment before CAR therapy | .69 | .07 | |||||
| 1 | 1 | 0 | 1 | 0 | 8 | ||
| 2 | 5 | 2 | 7 | 1 | 39 | ||
| 3 | 7 | 8 | 15 | 3 | 39 | ||
| >4 | 10 | 7 | 17 | 11 | 43 | ||
| Prior SCT | 0 | 0 | 1.0 | 0 | 1 | 10 | .16 |
| Previous CRT/CSI | 3 | 2 | 1.0 | 5 | 3 | 6 | .037 |
| Time from diagnosis to CAR infusion, mo | 45 (4-135) | 52 (5-94) | .76 | 51 (4-135) | 50 (4-171) | 27 (3-164) | .01 |
| Time from relapse to CAR infusion, mo | 3 (2-19) | 2 (1-13) | .50 | 3 (1-19) | 3 (1-12) | 3 (0-12) | .10 |
| Prophylactic levetiracetam | 1.0 | .13 | |||||
| Yes | 16 | 11 | 27 | 6 | 67 | ||
| No | 7 | 6 | 13 | 9 | 60 | ||
| Unknown | 0 | 0 | 0 | 0 | 2 | ||
CRT, cranial radiation; CSI, craniospinal radiation; iCNS, isolated CNS disease; NCI, National Cancer Institute.