Patient and treatment characteristics by disease cohort
| Disease cohort (n, %) . | ALL (n = 62; 36%) . | CLL (n = 48; 28%) . | NHL (n = 63; 36%) . | Total (N = 173) . |
|---|---|---|---|---|
| Age (y), median (IQR) [range] | 40 (28, 54) [20-76] | 61 (55, 66) [40-73] | 58 (52, 64) [28-71] | 55 (43, 64) [20-76] |
| Sex, n (%) Female Male | 26 (42) 36 (58) | 15 (31) 33 (69) | 17 (27) 46 (73) | 58 (34) 115 (66) |
| Race, n (%) White Nonwhite Unknown | 50 (80.6) 12 (19.4) 0 (0) | 43 (90) 4 (8.3) 1 (2.1) | 58 (92) 5 (7.9) 0 (0) | 151 (87) 21 (12) 1 (0.6) |
| Prior therapies, median n (IQR) [range] | 3 (2, 4) [1-11] | 5 (4, 7) [1-10] | 4 (4, 6) [1-11] | 4 (3, 6) [1-11] |
| Prior HSCT, n (%) Autologous Allogeneic Both None | 0 (0) 24 (39) 0 (0) 38 (61) | 1 (2) 7 (15) 0 (0) 40 (83) | 22 (35) 4 (6.3) 3 (4.8) 34 (54) | 23 (13) 35 (20) 3 (1.7) 112 (65) |
| Pre-LD marrow abnormal B-cells (%), median (IQR) [range] | 22.2 (1, 71) [0-98] | 52 (20, 74) [0-96] | 0 (0, 0) [0-92] | 8 (0, 57) [0-98] |
| Pre-LD ANCs (×109/L), median (IQR) [range] | 1.86 (0.88, 3.06) [0-7.62] | 2.13 (0.94, 4.30) [0-13.65] | 3.24 (1.98, 5.50) [0.23-23.17] | 2.41 (1.25, 4.23) [0-23.2] |
| Pre-LD ALCs (×109/L), median (IQR) [range] | 0.7 (0.4, 1.3) [0-5.1] | 1.9 (1.0, 7.6) [0.2-58.9] | 0.6 (0.4, 1.1) [0-8.8] | 0.9 (0.5, 1.7) [0-58.9] |
| Pre-LD hemoglobin (g/dL), median (IQR) [range] | 10.6 (9.8, 11.7) [7.3-14.8] | 10.6 (9.8, 12.35) [7.4-16] | 11.1 (9.8, 12.7) [7.2-15] | 10.8 (9.8, 12.2) [7.2-16] |
| Pre-LD platelets (×109/L), median (IQR) [range] | 110 (48, 200) [9-339] | 114 (86, 146) [7-434] | 143 (80, 214) [9-448] | 123 (64, 196) [7-448] |
| Lymphodepletion, n (%) High-intensity CyFlu Low-intensity CyFlu Non-CyFlu | 31 (50) 19 (31) 12 (19) | 15 (31) 29 (60) 4 (8.3) | 34 (54) 18 (29) 11 (17) | 80 (46) 66 (38) 27 (16) |
| CAR T-cell dose, n (%) DL1 DL2 DL3 | 38 (61) 22 (35) 2 (3.2) | 5 (10) 42 (88) 1 (2.1) | 4 (6) 50 (79) 9 (14) | 47 (27) 114 (66) 12 (6.9) |
| CRS grade, n (%) 0 1 2 3-5 | 14 (23) 12 (19) 23 (37) 13 (21) | 8 (17) 15 (31) 18 (38) 7 (15) | 30 (48) 13 (21) 14 (22) 6 (9.5) | 52 (30) 40 (23) 55 (32) 26 (15) |
| Neurotoxicity grade, n (%) 0-1 2-3 4-5 | 39 (63) 19 (31) 4 (6.5) | 32 (67) 15 (31) 1 (2.1) | 50 (79) 11 (17) 2 (3.2) | 121 (70) 45 (26.0) 7 (4.0) |
| Disease cohort (n, %) . | ALL (n = 62; 36%) . | CLL (n = 48; 28%) . | NHL (n = 63; 36%) . | Total (N = 173) . |
|---|---|---|---|---|
| Age (y), median (IQR) [range] | 40 (28, 54) [20-76] | 61 (55, 66) [40-73] | 58 (52, 64) [28-71] | 55 (43, 64) [20-76] |
| Sex, n (%) Female Male | 26 (42) 36 (58) | 15 (31) 33 (69) | 17 (27) 46 (73) | 58 (34) 115 (66) |
| Race, n (%) White Nonwhite Unknown | 50 (80.6) 12 (19.4) 0 (0) | 43 (90) 4 (8.3) 1 (2.1) | 58 (92) 5 (7.9) 0 (0) | 151 (87) 21 (12) 1 (0.6) |
| Prior therapies, median n (IQR) [range] | 3 (2, 4) [1-11] | 5 (4, 7) [1-10] | 4 (4, 6) [1-11] | 4 (3, 6) [1-11] |
| Prior HSCT, n (%) Autologous Allogeneic Both None | 0 (0) 24 (39) 0 (0) 38 (61) | 1 (2) 7 (15) 0 (0) 40 (83) | 22 (35) 4 (6.3) 3 (4.8) 34 (54) | 23 (13) 35 (20) 3 (1.7) 112 (65) |
| Pre-LD marrow abnormal B-cells (%), median (IQR) [range] | 22.2 (1, 71) [0-98] | 52 (20, 74) [0-96] | 0 (0, 0) [0-92] | 8 (0, 57) [0-98] |
| Pre-LD ANCs (×109/L), median (IQR) [range] | 1.86 (0.88, 3.06) [0-7.62] | 2.13 (0.94, 4.30) [0-13.65] | 3.24 (1.98, 5.50) [0.23-23.17] | 2.41 (1.25, 4.23) [0-23.2] |
| Pre-LD ALCs (×109/L), median (IQR) [range] | 0.7 (0.4, 1.3) [0-5.1] | 1.9 (1.0, 7.6) [0.2-58.9] | 0.6 (0.4, 1.1) [0-8.8] | 0.9 (0.5, 1.7) [0-58.9] |
| Pre-LD hemoglobin (g/dL), median (IQR) [range] | 10.6 (9.8, 11.7) [7.3-14.8] | 10.6 (9.8, 12.35) [7.4-16] | 11.1 (9.8, 12.7) [7.2-15] | 10.8 (9.8, 12.2) [7.2-16] |
| Pre-LD platelets (×109/L), median (IQR) [range] | 110 (48, 200) [9-339] | 114 (86, 146) [7-434] | 143 (80, 214) [9-448] | 123 (64, 196) [7-448] |
| Lymphodepletion, n (%) High-intensity CyFlu Low-intensity CyFlu Non-CyFlu | 31 (50) 19 (31) 12 (19) | 15 (31) 29 (60) 4 (8.3) | 34 (54) 18 (29) 11 (17) | 80 (46) 66 (38) 27 (16) |
| CAR T-cell dose, n (%) DL1 DL2 DL3 | 38 (61) 22 (35) 2 (3.2) | 5 (10) 42 (88) 1 (2.1) | 4 (6) 50 (79) 9 (14) | 47 (27) 114 (66) 12 (6.9) |
| CRS grade, n (%) 0 1 2 3-5 | 14 (23) 12 (19) 23 (37) 13 (21) | 8 (17) 15 (31) 18 (38) 7 (15) | 30 (48) 13 (21) 14 (22) 6 (9.5) | 52 (30) 40 (23) 55 (32) 26 (15) |
| Neurotoxicity grade, n (%) 0-1 2-3 4-5 | 39 (63) 19 (31) 4 (6.5) | 32 (67) 15 (31) 1 (2.1) | 50 (79) 11 (17) 2 (3.2) | 121 (70) 45 (26.0) 7 (4.0) |
High-intensity CyFlu, cyclophosphamide (Cy) 60 mg/kg or >1500 mg/m2 with fludarabine (Flu) 75-125 mg/m2; low-intensity CyFlu, Cy 30 mg/kg or ≤1500 mg/m2 with Flu 75-90 mg/m2; Non-CyFlu, any conditioning regimen other than as noted above including single agent Cy or Flu. CAR T-cell dose level (DL): DL1 = 2 × 105 cells/kg, DL2 = 2 × 106 cells/kg, DL3 = 2 × 107 cells/kg. CRS grade as defined by Lee criteria.24 Neurotoxicity grade as defined by CTCAE 4.0.3. ALC, absolute lymphocyte count; IQR, interquartile range.