Validation cohort demographic comparisons and incidence of severe prolonged neutropenia
| Validation cohort demographic comparisons . | ||||||
|---|---|---|---|---|---|---|
| Characteristic . | NCI . | MSK . | SCH . | |||
| (n = 156) . | (n = 106) . | (n = 84) . | ||||
| Age, median (range), y | 15.8 (4.3-38.7) | 27.5 (0.7-73.8) | 12.4 (1.5-26.0) | |||
| Male sex, no. (%) | 108 (69) | 68 (63) | 51 (61) | |||
| Prior CAR T-cell therapy, no. (%) | 62 (40) | 2 (2) | 5 (6) | |||
| ≥5 Prior lines of therapy, no. (%) | 81 (52) | 16 (15) | 14 (17) | |||
| Prior allogeneic HSCT, no. (%) | 88 (55) | 33 (31) | 48 (57) | |||
| CAR product, no. (%) | ||||||
| CD19 target containing constructs | CD19/28z | 49 (31) | CD19/28z | 72 (68) | CD19/41BB | 84 (100) |
| CD19-22 bicistronic | 4 (3) | tisagenlecleucel | 26 (24) | |||
| CD19-22 bivalent | 29 (19) | brexucabtagene autoleucel | 8 (8) | |||
| CD22 targeted only | CD22/41BB | 74 (47) | ||||
| Baseline complete blood cell count, median | ||||||
| ANC cells per μL (95% CI) | 1380 | 1300 | 1096 | |||
| (1020-1890) | (700-1500) | (709-1644) | ||||
| Platelet count, ×103/μL (95% CI) | 122 | 106 | 101.5 | |||
| (90-141) | (78-130) | (60-169) | ||||
| Hemoglobin, g/dL (95% CI) | 10.4 | 9.1 | 10.5 | |||
| (10-10.9) | (8.5-9.6) | (9.6-11.1) | ||||
| Baseline markers of inflammation, median | ||||||
| Ferritin, ng/mL (95% CI) | 1421 (n = 65) | 1435 (n = 66) | 1515∗ | |||
| (1011-1917) | (963-1772) | (954-2110) | ||||
| C-reactive protein, mg/dL (95% CI) | 0.42 (n = 145) | 0.96 (n = 66) | NA | |||
| (0.25-0.66) | (0.65-1.56) | |||||
| Baseline bone marrow disease | ||||||
| % Baseline bone marrow disease, median (95% CI) | 27.1 | 5.5 | 19.5 | |||
| (8.4-40.0) | (2.2-23.0) | (3.9-46) | ||||
| Post-CAR T-cell hematotoxicity | ||||||
| Cumulative days of ANC <500/μL D0-D30, median (95% CI) | 13 | 14 | 12 | |||
| (10-16) | (12-17) | (10-20) | ||||
| Severe prolonged neutropenia, no. (%) | 77 | 57 | 40 | |||
| (49) | (54) | (48) | ||||
| Validation cohort demographic comparisons . | ||||||
|---|---|---|---|---|---|---|
| Characteristic . | NCI . | MSK . | SCH . | |||
| (n = 156) . | (n = 106) . | (n = 84) . | ||||
| Age, median (range), y | 15.8 (4.3-38.7) | 27.5 (0.7-73.8) | 12.4 (1.5-26.0) | |||
| Male sex, no. (%) | 108 (69) | 68 (63) | 51 (61) | |||
| Prior CAR T-cell therapy, no. (%) | 62 (40) | 2 (2) | 5 (6) | |||
| ≥5 Prior lines of therapy, no. (%) | 81 (52) | 16 (15) | 14 (17) | |||
| Prior allogeneic HSCT, no. (%) | 88 (55) | 33 (31) | 48 (57) | |||
| CAR product, no. (%) | ||||||
| CD19 target containing constructs | CD19/28z | 49 (31) | CD19/28z | 72 (68) | CD19/41BB | 84 (100) |
| CD19-22 bicistronic | 4 (3) | tisagenlecleucel | 26 (24) | |||
| CD19-22 bivalent | 29 (19) | brexucabtagene autoleucel | 8 (8) | |||
| CD22 targeted only | CD22/41BB | 74 (47) | ||||
| Baseline complete blood cell count, median | ||||||
| ANC cells per μL (95% CI) | 1380 | 1300 | 1096 | |||
| (1020-1890) | (700-1500) | (709-1644) | ||||
| Platelet count, ×103/μL (95% CI) | 122 | 106 | 101.5 | |||
| (90-141) | (78-130) | (60-169) | ||||
| Hemoglobin, g/dL (95% CI) | 10.4 | 9.1 | 10.5 | |||
| (10-10.9) | (8.5-9.6) | (9.6-11.1) | ||||
| Baseline markers of inflammation, median | ||||||
| Ferritin, ng/mL (95% CI) | 1421 (n = 65) | 1435 (n = 66) | 1515∗ | |||
| (1011-1917) | (963-1772) | (954-2110) | ||||
| C-reactive protein, mg/dL (95% CI) | 0.42 (n = 145) | 0.96 (n = 66) | NA | |||
| (0.25-0.66) | (0.65-1.56) | |||||
| Baseline bone marrow disease | ||||||
| % Baseline bone marrow disease, median (95% CI) | 27.1 | 5.5 | 19.5 | |||
| (8.4-40.0) | (2.2-23.0) | (3.9-46) | ||||
| Post-CAR T-cell hematotoxicity | ||||||
| Cumulative days of ANC <500/μL D0-D30, median (95% CI) | 13 | 14 | 12 | |||
| (10-16) | (12-17) | (10-20) | ||||
| Severe prolonged neutropenia, no. (%) | 77 | 57 | 40 | |||
| (49) | (54) | (48) | ||||
Ferritin is from time of CAR T-cell infusion.