Table 1.
Patient characteristics.
| Characteristics | Total | CAR-T group | Chemotherapy group | P value |
|---|---|---|---|---|
| No. | 105 | 27 | 78 | |
| Median age, years (range) | 13.0(2-52) | 11(3-44) | 14.5(2-52) | 0.441 |
| Age group, no. (%) | 0.236 | |||
| ≥14 | 49(47) | 10(36) | 39(50) | |
| <14 | 56(53) | 17(63) | 39(50) | |
| Median donor age, years (range) | 33(8-63) | 31(16-54) | 33.5(8-63) | 0.550 |
| Gender, male, no. (%) | 61(58%) | 18(67) | 43(55) | 0.295 |
| With extramedullary disease (EMD), no (%) | 15(14) | 4(15) | 11(14) | 0.927 |
| Median duration from diagnosis to HSCT months (range) | 13.5(4-123) | 20(4-54) | 11(4-123) | 0.232 |
| Disease risk | 0.042 | |||
| R/R B-ALL, no (%) | 70(67) | 22(82) | 48(62) | |
| From diagnosis to first relapse time, no. (%) | ||||
| <18 months | 19(58) | 11(41) | 8(17) | |
| 18~36 months | 19(44) | 8(30) | 11(14) | |
| >36 months | 16(19) | 2(1) | 14(18) | |
| Primary refractory | 16(19) | 1(0) | 15(19) | |
| Persistent or relapsed MRD | 17(16) | 5(19) | 12(15) | |
| Others | 18(17) | 0 | 18(17) | |
| Disease status pre-transplant, no. (%) | <0.001 | |||
| CR1 | 55(52) | 6(22) | 49(63) | |
| ≥CR2 | 50(48) | 21(78) | 29(37) | |
| Donor source, no. (%) | 0.588 | |||
| Haplo-d | 66(63) | 16(59) | 50(64) | |
| MUD | 24(23) | 8(30) | 16(21) | |
| MSD | 15(14) | 3(11) | 12(15) | |
| FCM MRD-positive pre-conditioning, no. (%) | 33(31) | 6(22) | 27(35) | 0.232 |
| Fusion genes | 0.023 | |||
| BCR-ABL1 | 13(12) | 0 | 13(17) | |
| TEL-AML1 | 9(9) | 2(7) | 7(9) | |
| E2A-PBX1 | 4(4) | 3(11) | 1(1) | |
| MLL-AF4 | 4(4) | 0 | 4(5) | |
| MLL-AF1P | 1(1) | 1(4) | 0 | |
| MLL-ENL | 1(1) | 0 | 1(1) | |
| Gene mutations | ||||
| NRAS/KRAS | 12(11) | 5(11) | 7(9) | 0.16 |
| IKZF | 9(9) | 2(7) | 7(9) | 0.58 |
| TP53 | 5(5) | 2(7) | 3(4) | 0.383 |
| Flt3 ITD/KTD | 4(4) | 1(4) | 3(4) | 0.728 |
| High risk cytogenetics, no. (%) | 48(46) | 16(59) | 32(41) | 0.103 |
| Complex cytogenetic, no (%) | 17(16) | 12(44) | 5(6) | <0.001 |
| Donor-recipient gender match, n (%) | 0.263 | |||
| Female to male | 19(18) | 7(26) | 12(15) | |
| Others | 86(82) | 20(74) | 66(85) | |
| Conditioning regimens, no. (%) | 0.335 | |||
| TBI-based | 87(83) | 24(89) | 63(81) | |
| Bu-based | 18(17) | 3(11) | 15(19) | |
| Median CD34 cells,×106/kg(range) | 4.45(1.76-12.23) | 4.6(1.76-10.18) | 4.41(2.02-12.23) | 0.428 |
| Median CD3 cells,×108/kg(range) | 1.66(0.44-4.99) | 1.83(0.85-3.04) | 1.59(0.44-4.99) | 0.491 |
| Graft type, no. (%) | 0.41 | |||
| BM+PB | 80(76) | 19(70) | 61(78) | |
| PB | 25(24) | 8(30) | 17(22) | |
| Neutrophil engraftment, days (range) | 14(10-29) | 14(11-20) | 4(10-29) | 0.973 |
| Platelet engraftment, days (range) | 12(4-47) | 14(5-47) | 12(4-32) | 0.026 |
| Median follow-up time in survivor, months (range) | 49 (25-54) | 49 (44-53) | 49 (25-54) | 0.831 |