Patient characteristics
| Characteristic . | No. (%) (N = 25) . |
|---|---|
| Median age, y (range) | 11 (1.7-16.9) |
| Age category, y | |
| >1 to ≤2 | 1 (4) |
| >2 to ≤6 | 4 (16) |
| >6 | 20 (80) |
| Sex | |
| Male | 17 (68) |
| Female | 8 (32) |
| Bone marrow status at screening | |
| M3 | 22 (88) |
| M2 | 3 (12) |
| Median white blood cell count at screening × 109/L (range) | 3.5 (0.19-8.59) |
| Disease status at enrollment | |
| First relapse after HSCT | 7 (28) |
| Second or greater relapse | 15 (60) |
| Refractory | 3 (12) |
| Median No. of previous treatments (range) | 2 (2-7) |
| Specific elements of previous treatment | |
| HSCT | 14 (56) |
| Blinatumomab | 6 (24) |
| CAR T-cell therapy | 1 (4) |
| CD22 expression at screening | |
| Median MFI for CD22+ ALL cells (range) | 2768 (505-8370) |
| % CD22+ blasts (range) | 98 (53-100) |
| Cytogenetic subtype* | |
| Hypodiploid | 4 (16) |
| Hyperdiploid | 13 (52) |
| t[1;19](q23;p13) | 2 (8) |
| t[4;11](q21;q23) | 1 (4) |
| Normal cytogenetics | 4 (16) |
| Not done | 1 (4) |
| Characteristic . | No. (%) (N = 25) . |
|---|---|
| Median age, y (range) | 11 (1.7-16.9) |
| Age category, y | |
| >1 to ≤2 | 1 (4) |
| >2 to ≤6 | 4 (16) |
| >6 | 20 (80) |
| Sex | |
| Male | 17 (68) |
| Female | 8 (32) |
| Bone marrow status at screening | |
| M3 | 22 (88) |
| M2 | 3 (12) |
| Median white blood cell count at screening × 109/L (range) | 3.5 (0.19-8.59) |
| Disease status at enrollment | |
| First relapse after HSCT | 7 (28) |
| Second or greater relapse | 15 (60) |
| Refractory | 3 (12) |
| Median No. of previous treatments (range) | 2 (2-7) |
| Specific elements of previous treatment | |
| HSCT | 14 (56) |
| Blinatumomab | 6 (24) |
| CAR T-cell therapy | 1 (4) |
| CD22 expression at screening | |
| Median MFI for CD22+ ALL cells (range) | 2768 (505-8370) |
| % CD22+ blasts (range) | 98 (53-100) |
| Cytogenetic subtype* | |
| Hypodiploid | 4 (16) |
| Hyperdiploid | 13 (52) |
| t[1;19](q23;p13) | 2 (8) |
| t[4;11](q21;q23) | 1 (4) |
| Normal cytogenetics | 4 (16) |
| Not done | 1 (4) |
All data are presented as No. (%) unless otherwise specified.
MFI, mean fluorescence intensity.
Patients can have both hypodiploidy and a translocation.