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) |
| . | 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.