Risk factor analysis in all patients: estimates at 24 months
| Variable . | Group . | N∗ . | pEFS, % . | P value . | OS, % . | P value . | pRFS, % . | P value . | pDBA, % . | P value . | CIR, % . | P value . | CIR CD19+, % . | P value . | CIR CD19−, % . | P value . | NRM, % . | P value . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, y | 1-6 | 19/17 | 37.6 | .438 | 32.9 | .503 | 42.0 | .189 | 42.9 | .126 | 51.7 | .278 | 45.4 | .109 | 6.3 | .568 | 0.0 | .614 |
| 7-12 | 26/25 | 50.7 | 56.4 | 52.7 | 31.3 | 43.1 | 22.2 | 20.9 | 4.2 | |||||||||
| 13-17 | 16/13 | 46.4 | 66.7 | 57.1 | 61.2 | 42.9 | 26.7 | 16.2 | 0.0 | |||||||||
| 18-25 | 20/15 | 46.8 | 62.2 | 58.7 | 62.7 | 32.1 | 25.5 | 6.7 | 6.7 | |||||||||
| Patient category | Pediatric | 61/55 | 45.4 | .912 | 50.6 | .883 | 50.3 | .548 | 44.4 | .482 | 45.9 | .305 | 30.2 | .617 | 15.7 | .439 | 1.9 | .306 |
| Adults | 20/15 | 46.8 | 62.2 | 58.7 | 62.7 | 32.1 | 25.5 | 6.7 | 6.7 | |||||||||
| Leukemia cytogenetics | Favorable | 11/10 | 45.5 | .405 | 60.6 | .190 | 50.0 | .808 | 31.1 | .407 | 40.0 | .998 | 30.0 | .279 | 10.0 | .116 | 10.0 | .276 |
| Intermediate risk | 41/33 | 39.9 | 42.3 | 49.5 | 61.4 | 43.9 | 19.8 | 24.1 | 3.4 | |||||||||
| High risk | 29//27 | 52.2 | 65.2 | 54.1 | 47.1 | 44.4 | 40.7 | 3.7 | 0.0 | |||||||||
| Leukemia site involvement | Isolated BM | 41/33 | 44.5 | .930 | 54.2 | .913 | 55.3 | .895 | 58.3 | .506 | 38.6 | .584 | 23.4 | .447 | 15.3 | .380 | 3.0 | .273 |
| Isolated CNS | 7/7 | 57.1 | 71.4 | 57.1 | 50.0 | 28.6 | 28.6 | 0.0 | 14.3 | |||||||||
| BM + CNS | 13/12 | 46.3 | 44.4 | 46.3 | 48.6 | 53.7 | 26.9 | 26.9 | 0.0 | |||||||||
| Other | 20/18 | 46.9 | 45.2 | 52.1 | 38.5 | 45.6 | 39.2 | 6.4 | 0.0 | |||||||||
| HSCT before CAR T-cell therapy | No | 16/13 | 55.0 | .614 | 55.2 | .851 | 67.7 | .294 | 76.9 | .356 | 32.3 | .501 | 16.2 | .392 | 16.2 | .868 | 0.0 | .490 |
| Yes | 65/57 | 43.4 | 53.2 | 48.6 | 45.0 | 45.1 | 31.9 | 13.1 | 3.6 | |||||||||
| Remission status at LDC | <5% blasts | 44/42 | 55.4 | .049 | 59.1 | .105 | 58.1 | .374 | 50.5 | .798 | 41.9 | .863 | 26.6 | .851 | 15.3 | .692 | 0.0 | .083 |
| ≥5% blasts | 37/28 | 29.6 | 46.3 | 37.9 | 52.7 | 49.0 | 37.4 | 11.6 | 7.3 | |||||||||
| Cyclophosphamide dose for LDC (mg/m2) | <1000 | 26/21 | 41.2 | .719 | 47.3 | .781 | 51.0 | .553 | 35.3 | .713 | 49.0 | .488 | 49.0 | .405 | 0.0 | .062 | 0.0 | .427 |
| 1000-1499 | 28/25 | 36.8 | 50.3 | 41.2 | 42.2 | 52.3 | 27.2 | 25.1 | 4.2 | |||||||||
| ≥1500 | 24/21 | 54.9 | 59.6 | 59.9 | 72.9 | 35.4 | 20.4 | 15.0 | 0.0 | |||||||||
| Fludarabine dose for LDC (mg/m2) | <120 | 24/21 | 49.7 | .988 | 51.1 | .739 | 56.8 | .988 | 27.2 | .843 | 36.7 | .637 | 31.6 | .565 | 5.1 | .164 | 4.8 | .149 |
| ≥120 | 54/46 | 43.6 | 54.9 | 50.1 | 55.0 | 47.6 | 29.0 | 18.7 | 0.0 |
| Variable . | Group . | N∗ . | pEFS, % . | P value . | OS, % . | P value . | pRFS, % . | P value . | pDBA, % . | P value . | CIR, % . | P value . | CIR CD19+, % . | P value . | CIR CD19−, % . | P value . | NRM, % . | P value . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, y | 1-6 | 19/17 | 37.6 | .438 | 32.9 | .503 | 42.0 | .189 | 42.9 | .126 | 51.7 | .278 | 45.4 | .109 | 6.3 | .568 | 0.0 | .614 |
| 7-12 | 26/25 | 50.7 | 56.4 | 52.7 | 31.3 | 43.1 | 22.2 | 20.9 | 4.2 | |||||||||
| 13-17 | 16/13 | 46.4 | 66.7 | 57.1 | 61.2 | 42.9 | 26.7 | 16.2 | 0.0 | |||||||||
| 18-25 | 20/15 | 46.8 | 62.2 | 58.7 | 62.7 | 32.1 | 25.5 | 6.7 | 6.7 | |||||||||
| Patient category | Pediatric | 61/55 | 45.4 | .912 | 50.6 | .883 | 50.3 | .548 | 44.4 | .482 | 45.9 | .305 | 30.2 | .617 | 15.7 | .439 | 1.9 | .306 |
| Adults | 20/15 | 46.8 | 62.2 | 58.7 | 62.7 | 32.1 | 25.5 | 6.7 | 6.7 | |||||||||
| Leukemia cytogenetics | Favorable | 11/10 | 45.5 | .405 | 60.6 | .190 | 50.0 | .808 | 31.1 | .407 | 40.0 | .998 | 30.0 | .279 | 10.0 | .116 | 10.0 | .276 |
| Intermediate risk | 41/33 | 39.9 | 42.3 | 49.5 | 61.4 | 43.9 | 19.8 | 24.1 | 3.4 | |||||||||
| High risk | 29//27 | 52.2 | 65.2 | 54.1 | 47.1 | 44.4 | 40.7 | 3.7 | 0.0 | |||||||||
| Leukemia site involvement | Isolated BM | 41/33 | 44.5 | .930 | 54.2 | .913 | 55.3 | .895 | 58.3 | .506 | 38.6 | .584 | 23.4 | .447 | 15.3 | .380 | 3.0 | .273 |
| Isolated CNS | 7/7 | 57.1 | 71.4 | 57.1 | 50.0 | 28.6 | 28.6 | 0.0 | 14.3 | |||||||||
| BM + CNS | 13/12 | 46.3 | 44.4 | 46.3 | 48.6 | 53.7 | 26.9 | 26.9 | 0.0 | |||||||||
| Other | 20/18 | 46.9 | 45.2 | 52.1 | 38.5 | 45.6 | 39.2 | 6.4 | 0.0 | |||||||||
| HSCT before CAR T-cell therapy | No | 16/13 | 55.0 | .614 | 55.2 | .851 | 67.7 | .294 | 76.9 | .356 | 32.3 | .501 | 16.2 | .392 | 16.2 | .868 | 0.0 | .490 |
| Yes | 65/57 | 43.4 | 53.2 | 48.6 | 45.0 | 45.1 | 31.9 | 13.1 | 3.6 | |||||||||
| Remission status at LDC | <5% blasts | 44/42 | 55.4 | .049 | 59.1 | .105 | 58.1 | .374 | 50.5 | .798 | 41.9 | .863 | 26.6 | .851 | 15.3 | .692 | 0.0 | .083 |
| ≥5% blasts | 37/28 | 29.6 | 46.3 | 37.9 | 52.7 | 49.0 | 37.4 | 11.6 | 7.3 | |||||||||
| Cyclophosphamide dose for LDC (mg/m2) | <1000 | 26/21 | 41.2 | .719 | 47.3 | .781 | 51.0 | .553 | 35.3 | .713 | 49.0 | .488 | 49.0 | .405 | 0.0 | .062 | 0.0 | .427 |
| 1000-1499 | 28/25 | 36.8 | 50.3 | 41.2 | 42.2 | 52.3 | 27.2 | 25.1 | 4.2 | |||||||||
| ≥1500 | 24/21 | 54.9 | 59.6 | 59.9 | 72.9 | 35.4 | 20.4 | 15.0 | 0.0 | |||||||||
| Fludarabine dose for LDC (mg/m2) | <120 | 24/21 | 49.7 | .988 | 51.1 | .739 | 56.8 | .988 | 27.2 | .843 | 36.7 | .637 | 31.6 | .565 | 5.1 | .164 | 4.8 | .149 |
| ≥120 | 54/46 | 43.6 | 54.9 | 50.1 | 55.0 | 47.6 | 29.0 | 18.7 | 0.0 |
Number of patients for estimation of pEFS and pOS/number of patients for estimation of pRFS, pDBA, CIR, and NRM.