CR rate, CRS, neurotoxicity, and CAR peak (N = 110)
| Subgroup . | CR rate . | Grade 3 to 4 CRS . | Grade 2 to 3 neurotoxicity . | CAR T-cell peak . | ||||
|---|---|---|---|---|---|---|---|---|
| n/N (%) . | P . | n/N (%) . | P . | n/N (%) . | P . | % ± SD . | P . | |
| Age, y | 1 | .837 | .692 | .363 | ||||
| 2-14 | 66/71 (92.9) | 12/71 (16.9) | 9/71 (12.7) | 27.12 ± 2.723 | ||||
| 15-61 | 36/39 (92.3) | 6/39 (15.4) | 6/39 (15.4) | 31.34 ± 3.765 | ||||
| Sex | .052 | .946 | .876 | .444 | ||||
| Female | 36/42 (85.7) | 7/42 (16.7) | 6/42 (14.3) | 26.46 ± 3.177 | ||||
| Male | 66/68 (97.1) | 11/68 (16.2) | 9/68 (13.2) | 29.95 ± 2.986 | ||||
| BCR-ABL fusion gene | .568 | .318 | .111 | .113 | ||||
| BCR-ABL+ | 14/14 (100) | 1/14 (7.1) | 0/14 (0) | 19.44 ± 4.386 | ||||
| BCR-ABL– | 88/96 (91.7) | 17/96 (17.7) | 15/96 (15.6) | 29.95 ± 2.421 | ||||
| TP53 mutation | 1 | .426 | .571 | .12 | ||||
| TP53+ | 91/98 (92.9) | 17/98 (17.3) | 14/98 (14.3) | 27.42 ± 2.321 | ||||
| TP53– | 11/12 (91.7) | 1/12 (8.3) | 1/12 (8.3) | 38.42 ± 6.641 | ||||
| EMD | .455 | .881 | .926 | .010* | ||||
| Without | 82/87 (94.3) | 14/87 (16.1) | 12/87 (13.8) | 31.55 ± 2.591 | ||||
| With | 20/23 (87.0) | 4/23 (17.4) | 3/23 (13.0) | 17.66 ± 3.008 | ||||
| BM blasts≤20% vs >20%,% | .015* | .002† | .001† | .025* | ||||
| ≤20 | 65/66 (98.5) | 5/66 (7.5) | 3/66 (4.5) | 24.59 ± 2.711 | ||||
| >20 | 37/44 (84.1) | 13/44 (29.5) | 12/44 (27.3) | 34.65 ± 3.570 | ||||
| BM blasts<5% vs ≥5%,% | .018* | .040* | .033* | .001† | ||||
| <5 | 42/42 (100) | 3/42 (7.1) | 2/42 (4.8) | 19.62 ± 2.812 | ||||
| ≥5 | 60/68 (88.2) | 15/68 (22.1) | 13/68 (19.1) | 34.17 ± 2.933 | ||||
| Costimulatory domain | .042* | .007† | .003† | .013* | ||||
| CD28 | 17/21 (80.9) | 8/21 (38.1) | 7/21 (33.3) | 17.42 ± 3.017 | ||||
| 4-1BB | 85/89 (95.5) | 10/89 (11.2) | 8/89 (9.0) | 31.26 ± 2.557 | ||||
| With or without previous transplant | 1 | .780 | .519 | .366 | ||||
| No previous transplant | 15/16 (93.8) | 3/16 (18.8) | 3/16 (18.8) | 23.75 ± 3.723 | ||||
| Posttransplant relapse | 87/94 (92.6) | 15/94 (16.0) | 12/94 (12.8) | 29.44 ± 2.498 | ||||
| CAR T-cell dose | .228 | .100 | .116 | .018* | ||||
| <3 × 105 cells per kg | 48/50 (96.0) | 5/50 (10.0) | 4/50 (8.0) | 34.42 ± 3.61 | ||||
| ≥3 × 105 cells per kg | 54/60 (90.0) | 13/60 (21.7) | 11/60 (18.3) | 23.96 ± 2.60 | ||||
| Subgroup . | CR rate . | Grade 3 to 4 CRS . | Grade 2 to 3 neurotoxicity . | CAR T-cell peak . | ||||
|---|---|---|---|---|---|---|---|---|
| n/N (%) . | P . | n/N (%) . | P . | n/N (%) . | P . | % ± SD . | P . | |
| Age, y | 1 | .837 | .692 | .363 | ||||
| 2-14 | 66/71 (92.9) | 12/71 (16.9) | 9/71 (12.7) | 27.12 ± 2.723 | ||||
| 15-61 | 36/39 (92.3) | 6/39 (15.4) | 6/39 (15.4) | 31.34 ± 3.765 | ||||
| Sex | .052 | .946 | .876 | .444 | ||||
| Female | 36/42 (85.7) | 7/42 (16.7) | 6/42 (14.3) | 26.46 ± 3.177 | ||||
| Male | 66/68 (97.1) | 11/68 (16.2) | 9/68 (13.2) | 29.95 ± 2.986 | ||||
| BCR-ABL fusion gene | .568 | .318 | .111 | .113 | ||||
| BCR-ABL+ | 14/14 (100) | 1/14 (7.1) | 0/14 (0) | 19.44 ± 4.386 | ||||
| BCR-ABL– | 88/96 (91.7) | 17/96 (17.7) | 15/96 (15.6) | 29.95 ± 2.421 | ||||
| TP53 mutation | 1 | .426 | .571 | .12 | ||||
| TP53+ | 91/98 (92.9) | 17/98 (17.3) | 14/98 (14.3) | 27.42 ± 2.321 | ||||
| TP53– | 11/12 (91.7) | 1/12 (8.3) | 1/12 (8.3) | 38.42 ± 6.641 | ||||
| EMD | .455 | .881 | .926 | .010* | ||||
| Without | 82/87 (94.3) | 14/87 (16.1) | 12/87 (13.8) | 31.55 ± 2.591 | ||||
| With | 20/23 (87.0) | 4/23 (17.4) | 3/23 (13.0) | 17.66 ± 3.008 | ||||
| BM blasts≤20% vs >20%,% | .015* | .002† | .001† | .025* | ||||
| ≤20 | 65/66 (98.5) | 5/66 (7.5) | 3/66 (4.5) | 24.59 ± 2.711 | ||||
| >20 | 37/44 (84.1) | 13/44 (29.5) | 12/44 (27.3) | 34.65 ± 3.570 | ||||
| BM blasts<5% vs ≥5%,% | .018* | .040* | .033* | .001† | ||||
| <5 | 42/42 (100) | 3/42 (7.1) | 2/42 (4.8) | 19.62 ± 2.812 | ||||
| ≥5 | 60/68 (88.2) | 15/68 (22.1) | 13/68 (19.1) | 34.17 ± 2.933 | ||||
| Costimulatory domain | .042* | .007† | .003† | .013* | ||||
| CD28 | 17/21 (80.9) | 8/21 (38.1) | 7/21 (33.3) | 17.42 ± 3.017 | ||||
| 4-1BB | 85/89 (95.5) | 10/89 (11.2) | 8/89 (9.0) | 31.26 ± 2.557 | ||||
| With or without previous transplant | 1 | .780 | .519 | .366 | ||||
| No previous transplant | 15/16 (93.8) | 3/16 (18.8) | 3/16 (18.8) | 23.75 ± 3.723 | ||||
| Posttransplant relapse | 87/94 (92.6) | 15/94 (16.0) | 12/94 (12.8) | 29.44 ± 2.498 | ||||
| CAR T-cell dose | .228 | .100 | .116 | .018* | ||||
| <3 × 105 cells per kg | 48/50 (96.0) | 5/50 (10.0) | 4/50 (8.0) | 34.42 ± 3.61 | ||||
| ≥3 × 105 cells per kg | 54/60 (90.0) | 13/60 (21.7) | 11/60 (18.3) | 23.96 ± 2.60 | ||||