Table 1.
Patient and disease characteristics.
| Variables | Training cohort | Validation cohort |
|---|---|---|
| Age, median (range) | 43 (12-66) | 43 (19-69) |
| Gender, n (%) | ||
| Male | 18 (51.4) | 20 (55.6) |
| Female | 17 (48.6) | 16 (44.4) |
| Disease, n (%) | ||
| B-ALL | 22 (62.9) | 9 (25) |
| Large B-cell lymphoma | 13 (37.1) | 27 (75) |
| Tumor burden prior CAR-T | ||
| B-ALL | ||
| Bone marrow blasts, median (%, range) | 8 (0-92) | 26.8 (0-93) |
| Large B-cell lymphoma | ||
| Ann Arbor stage | ||
| I-II | 2 (15.4) | 4 (14.8) |
| III-IV | 11 (84.6) | 23 (85.2) |
| IPI score | ||
| 0-2 | 7 (53.8) | 14 (51.9) |
| 3-5 | 6 (46.2) | 13 (48.1) |
| LDH levels pre-lymphodepletion, median (range) | 263 (173-1404) | 228 (113-1289) |
| Lines of prior therapies, median (range) | 6 (2-18) | 7 (4-16) |
| Baseline blood count, median (range) | ||
| WBC (×109/L) | 4.82 (0.13-22.61) | 3.7 (1.44-13.03) |
| Neutrophil (×109/L) | 2.92 (0.06-14.11) | 2.49 (0.82-11.91) |
| Hemoglobin (g/dL) | 10 (4.8-14.6) | 10.5 (5.8-13.2) |
| Platelet (×109/L) | 140 (14-294) | 168 (54-401) |
| Prior autologous HSCT, n (%) | 9 (25.7) | 12 (33.3) |
| Prior allogeneic HSCT, n (%) | 7 (20) | 10 (27.8) |
| CAR-T cell dose (×106/kg) | 2.9 (0.35-6.7) | 3 (0.1-11.76) |
| CRS grade, n (%) | ||
| 0 | 5 (14.3) | 4 (11.1) |
| 1 | 14 (40) | 20 (55.6) |
| 2 | 8 (22.9) | 5 (13.9) |
| 3 | 5 (14.3) | 3 (8.3) |
| 4 | 3 (8.5) | 4 (11.1) |
| ICANS, n (%) | 2 (5.7) | 2 (5.6) |
| 3 month blood count after CAR-T cell therapy, median (range) | ||
| WBC (×109/L) | 3.85 (0.02-11.52) | 3.91 (0.17-6.78) |
| Neutrophil (×109/L) | 2 (0.01-5.31) | 1.77 (0.1-3.8) |
| Hemoglobin (g/dL) | 10.3 (3.1-15.8) | 12.3 (6.1-15.8) |
| Platelet (×109/L) | 90 (3-242) | 154 (9-283) |
| Blood complete recovery, n (%) | 20 (57.1) | 26 (72.2) |
B-ALL, B-cell acute lymphoblastic leukemia; LDH, lactate dehydrogenase; IPI, international prognostic index; CRS, cytokine release syndrome; HSCT, hematopoietic stem cell transplantation; WBC, white blood cell; CAR-T, chimeric antigen receptor T cell; ICANS, immune effector cell-associated neurotoxicity syndrome.