Table 4 CRS by Penn grading scale grade after tisagenlecleucel infusion in non-CNS3 pediatric patients with ALL
From: Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel
| Â | No CRS | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|
Number of patients, n (%) | 6 (10.9) | 3 (5.5) | 23 (41.8) | 10 (18.2) | 13 (23.6) |
Among patients with CRS* | |||||
CRS grade-defining events | |||||
 Hypotension that required intervention, n (%) | – | 0 | 1 (4.3) | 7 (70.0) | 12 (92.3) |
  High-dose vasopressors used, n (%) | – |  | 0 | 0 | 9 (69.2) |
 Oxygen supplementation given, n (%) | – | 0 | 0 | 3 (30.0) | 12 (92.3) |
 Patient intubated, n (%) | – | 0 | 0 | 0 | 6 (46.2) |
  Duration (days) | |||||
   Mean (SD) | – | – | – | – | 16.2 (23.24) |
   Median (range) | – | – | – | – | 7.5 (3.0–63.0) |
 Disseminated intravascular coagulation observed, n (%) | – | 0 | 0 | 0 | 7 (53.8) |
  Bleeding observed, n (%) | – | – | – | – | 4 (30.8) |
  Blood product support given for bleeding, n (%) | – | – | – | – | 5 (38.5) |
CRS timing | |||||
 Time to onset of CRS (days) | |||||
  Mean (SD) | – | 6.0 (4.36) | 5.2 (2.90) | 3.7 (2.41) | 2.0 (0.58) |
  Median (range) | – | 4.0 (3.0–11.0) | 5.0 (1.0–11.0) | 2.5 (1.0–7.0) | 2.0 (1.0–3.0) |
 Duration of CRS (days) | |||||
  Mean (SD) | – | 6.0 (2.00) | 4.7 (2.43) | 8.2 (3.74) | 11.2 (2.03) |
  Median (range) | – | 6.0 (4.0–8.0) | 4.0 (2.0–10.0) | 7.0 (5.0–18.0) | 11.0 (7.0–15.0) |
Other CRS-associated events | |||||
 High (> 38.3 °C) fevers, n (%) | – | 1 (33.3) | 20 (87.0) | 10 (100) | 13 (100) |
  Duration (days) | |||||
   Mean (SD) | – | 4.0 | 4.7 (2.60) | 7.4 (3.72) | 8.1 (2.72) |
   Median (range) | – | 4.0 (4.0–4.0) | 5.0 (1.0–10.0) | 7.0 (3.0–17.0) | 8.0 (4.0–13.0) |
 Admitted to ICU, n (%) | – | 0 | 0 | 7 (70.0) | 13 (100) |
  Time to ICU admission (days) | |||||
   Mean (SD) | – | – | – | 5.7 (2.29) | 5.8 (1.86) |
   Median (range) | – | – | – | 7.0 (2.0–8.0) | 6.0 (3.0–10.0) |
  Duration of ICU stay (days) | |||||
   Mean (SD) | – | – | – | 4.0 (2.65) | 16.2 (16.42) |
   Median (range) | – | – | – | 3.0 (1.0–9.0) | 11.0 (4.0–68.0) |
  Patient dialyzed, n (%) | – | 0 | 0 | 0 | 0 |
  Pulmonary abnormalities, n (%) | – | 0 | 0 | 0 | 6 (46.2) |
Anti-cytokine therapy | |||||
 Systemic anti-cytokine therapy given, n (%) | – | 0 | 0 | 3 (30.0) | 13 (100) |
  Tocilizumab | – | – | – | 2 (20.0) | 13 (100) |
   1 dose | – | – | – | 2 (20.0) | 8 (61.5) |
   2 doses | – | – | – | 0 | 5 (38.5) |
  Corticosteroids | – | – | – | 2 (20.0) | 7 (53.8) |
  Other | – | – | – | 1 (10.0) | 1 (7.7) |