Table 1.
Patient characteristics
| All patients (N = 81) | With HSCT (N = 65) | Without HSCT (N = 16) | P value | |
|---|---|---|---|---|
| Age, y | .302 | |||
| Median | 11.5 | 10.0 | 14.5 | |
| Range | 1.0-25.0 | 1.0-25.0 | 1.2-25.0 | |
| Sex, n (%) | .755 | |||
| Female | 28 (34.6) | 23 (35.4) | 5 (31.2) | |
| Male | 53 (65.4) | 42 (64.6) | 11 (68.8) | |
| Body weight, kg | .299 | |||
| Median | 41.6 | 38.0 | 45.5 | |
| Range | 8.0-135.0 | 8.0-135.0 | 9.7-84.0 | |
| Preliminary treatment, n (%) | ||||
| Primary refractory | 1 (1.2) | 0 (0.0) | 1 (6.2) | |
| Relapsed refactory | 15 (18.5) | 0 (0.0) | 15 (93.8) | |
| HSCT | 65 (80.2) | 65 (100.0) | NA | |
| Leukemia cytogenetics, n (%) | .277 | |||
| Favorable | 11 (13.6) | 7 (10.8) | 4 (25.0) | |
| ETV6/RUNX1 | 8 (9.8) | 5 (7.7) | 3 (18.7) | |
| Other∗ | 3 (3.7) | 2 (3.1) | 1 (6.2) | |
| Intermediate risk | 41 (50.6) | 33 (50.8) | 8 (50.0) | |
| No specification | 33 (40.7) | 27 (41.5) | 6 (37.5) | |
| Other† | 8 (9.9) | 6 (9.2) | 2 (12.5) | |
| High risk | 29 (35.8) | 25 (38.5) | 4 (25.0) | |
| KMT2A rearrangement | 10 (12.3) | 8 (12.3) | 2 (12.5) | |
| BCR/ABL1 | 8 (9.9) | 8 (12.3) | 0 (0.0) | |
| Other‡ | 11 (13.6) | 9 (13.8) | 2 (12.5) | |
| Leukemia site involvement, n (%) | .892 | |||
| Isolated BM | 41 (50.6) | 34 (52.3) | 7 (43.8) | |
| Isolated CNS | 7 (8.6) | 5 (7.7) | 2 (12.5) | |
| BM + CNS | 13 (16.0) | 10 (15.4) | 3 (18.8) | |
| Other | 20 (24.7) | 16 (24.6) | 4 (25.0) | |
| Time from HSCT to relapse, mo, n (%) | ||||
| <6 | 22 (33.8) | 22 (33.8) | NA | |
| ≥6 | 43 (66.2) | 43 (66.2) | NA | |
| Bridging therapy, n (%) | .116 | |||
| Blinatumomab | 3 (3.7) | 2 (3.1) | 1 (6.2) | |
| Inotuzumab | 4 (4.9) | 2 (3.1) | 2 (12.5) | |
| Low-dose chemotherapy | 72 (88.9) | 60 (92.3) | 12 (75.0) | |
| Intensive chemotherapy | 1 (1.2) | 0 (0.0) | 1 (6.2) | |
| None | 1 (1.2) | 1 (1.5) | 0 (0.0) | |
| Remission status at LDC, n (%) | .196 | |||
| <5% blasts | 44 (54.3) | 33 (50.8) | 11 (68.8) | |
| ≥5% blasts | 37 (45.7) | 32 (49.2) | 5 (31.2) | |
| Cyclophosphamide dose for LDC, mg/m2, n (%) | .173 | |||
| No data | 3 | 3 | 0 | |
| <1000 | 26 (33.3) | 22 (35.5) | 4 (25.0) | |
| 1000-1499 | 28 (35.9) | 24 (38.7) | 4 (25.0) | |
| ≥1500 | 24 (30.8) | 16 (25.8) | 8 (50.0) | |
| Fludarabine dose for LDC, mg/m2, n (%) | .963 | |||
| No data | 3 | 3 | 0 | |
| <120 | 24 (30.8) | 19 (30.6) | 5 (31.2) | |
| ≥120 | 54 (69.2) | 43 (69.4) | 11 (68.8) |
NA, not applicable.
∗
Two patients with hyperdiploidy and 1 patient with CALB3.
†
Two patients with CRLF2 mutation, 2 patients with IKZF1plus, 1 patient with del13q14, 1 patient with cMYC rearrangement, 1 patient with t(12;22), and 1 patient with PAX5-ZNF521-fusion transcript t(9;18).
‡
Two patients with iAMP21, 2 patients with IKFZ deletion, 2 patients with BCR-ABL1–like, 1 patient with complex aberrant karyotype, 1 patient with MEF2D-BCL9, 1 patient with TCF3/HLF, 1 patient with JAK2-MPRIP t(9;17), and 1 patient with TP53 mutation.