Table 1.
Baseline demographics and disease burden by maximum CRS grade
| No CRS (n = 29) | Maximum CRS grade | ||||
|---|---|---|---|---|---|
| Grade 1/2 (n = 51) | Grade 3 (n = 27) | Grade 4 (n = 30) | Grade 3/4 (n = 57) | ||
| Age at initial diagnosis, y | |||||
| Median (min-max) | 7 (0-17) | 6 (1-19) | 8 (0-17) | 9 (1-21) | 8 (0-21) |
| Number of previous lines of therapy | |||||
| Median (min-max) | 3 (1-8) | 3 (1-9) | 4 (2-7) | 3 (1-6) | 3 (1-7) |
| Number of prior allogeneic stem cell transplantations, n (%) | |||||
| 0 | 11 (38) | 24 (47) | 11 (41) | 17 (57) | 28 (49) |
| 1 | 15 (52) | 26 (51) | 13 (48) | 12 (40) | 25 (44) |
| 2 | 3 (10) | 1 (2) | 3 (11) | 1 (3) | 4 (7) |
| Karnofsky/Lansky performance status | |||||
| Median (min-max) | 90 (50-100) | 90 (50-100) | 90 (70-100) | 90 (50-100) | 90 (50-100) |
| Leukemic blasts in bone marrow by flow cytometry, % | |||||
| n | 27 | 48 | 25 | 28 | 53 |
| Median (min-max) | 50 (0-97) | 40 (0-96) | 56 (1-99) | 64 (2-97) | 60 (1-99) |
| Bone marrow tumor burden at enrollment, n (%)* | |||||
| <50% | 10 (34.5) | 22 (43.1) | 6 (22.2) | 5 (16.7) | 11 (19.3) |
| ≥50% | 19 (65.5) | 29 (56.9) | 21 (77.8) | 25 (83.3) | 46 (80.7) |
| CNS status, n (%)† | |||||
| CNS-1 | 22 (75.9) | 44 (86.3) | 26 (96.3) | 26 (86.7) | 52 (91.2) |
| CNS-2 | 6 (20.7) | 7 (13.7) | 1 (3.7) | 3 (10.0) | 4 (7.0) |
| CNS-3 | 1 (3.4) | 0 | 0 | 0 | 0 |
| Unknown | 0 | 0 | 0 | 1 (3.3) | 1 (1.8) |
| Extramedullary disease, n (%)‡ | |||||
| Yes | 6 (20.7) | 7 (13.7) | 1 (3.7) | 2 (6.7) | 3 (5.3) |
| No | 23 (79.3) | 44 (86.3) | 26 (96.3) | 28 (93.3) | 54 (94.7) |
CNS, central nervous system; CSF, cerebrospinal fluid; MRD, minimal residual disease.
*
Includes MRD determined by flow cytometry and morphologic blast counts in bone marrow. If there are both MRD and morphologic results, the maximum is shown.
†
The classification of CNS status includes the following: CNS-1, no lymphoblasts in the CSF regardless of WBC count; CNS-2, WBC <5 cells/µL in the CSF, with the presence of lymphoblasts; CNS-3, WBC of ≥5 cells/µL, with the presence of lymphoblasts.
‡
Excludes CNS disease.