Table 1.
Baseline characteristics.
| Characteristic | All treated patients N=55 | All enrolled patients N=71 |
|---|---|---|
| Age, median (IQR), years | 40 (28–52) | 44 (30–59) |
| ≥65 years, n (%) | 8 (15) | 11 (15) |
| Male, n (%) | 33 (60) | 41 (58) |
| ECOG PS of 1, n (%)* | 39 (71) | 53 (75) |
| Philadelphia chromosome-positive, n (%) | 15 (27) | 19 (27) |
| Extramedullary disease at screening, n (%) | 6 (11) | 8 (11) |
| CNS-1 disease at baseline, n (%) †,‡ | 55 (100) | 69 (97) |
| Number of prior therapies, median (IQR) § | 2 (2–3) | 2 (2–3) |
| ≥3 prior lines of therapy, n (%) | 26 (47) | 35 (49) |
| Prior blinatumomab | 25 (45) | 33 (46) |
| Prior inotuzumab ozogamicin | 12 (22) | 16 (23) |
| Prior allogeneic SCT | 23 (42) | 28 (39) |
| Relapsed/refractory subgroup, n (%) | ||
| Primary refractory | 18 (33) | 21 (30) |
| Relapsed or refractory to ≥2 prior systemic therapy lines | 43 (78) | 54 (76) |
| First relapse with remission ≤12 months | 16 (29) | 20 (28) |
| Relapsed or refractory post-SCT¶ | 24 (44) | 29 (41) |
| BM blasts at screening | n=55 | n=70 |
| Median (IQR), % | 65 (24–87) | 70 (25–89) |
| ≤5%, n (%) | 0 | 1 (1) |
| >5% to 25%, n (%) | 16 (29) | 17 (24) |
| M3 BM involvement (>25% blasts), n (%) | 39 (71) | 52 (73) |
| BM blasts at baseline ‡ | n=55 | n=70 |
| Median (IQR), % | 60 (17–90) | 66·5 (34–90) |
| ≤5%, n (%) | 5 (9) | 6 (8) |
| >5% to 25%, n (%) | 10 (17) | 10 (14) |
| M3 BM involvement (>25% blasts), n (%) | 40 (73) | 54 (76) |
| BM blasts at preconditioning after bridging chemotherapy | n=46 | n=48 |
| Median (IQR), % | 59·0 (25–87) | 62·5 (26·5–88·5) |
| ≤5%, n (%) | 5 (9) | 5 (7) |
| >5% to 25%, n (%) | 7 (13) | 7 (10) |
| nM3 BM involvement (>25% blasts), n (%) | 34 (62) | 36 (51) |
All other patients had ECOG PS 0.
Five patients had CNS-2 disease at screening and data were missing for three patients. Per protocol, sites could administer intrathecal chemotherapy between screening and baseline, which could have resulted in a change of CNS status.
Baseline refers to the last value taken prior to conditioning chemotherapy.
Six patients had prior blinatumomab and prior inotuzumab ozogamicin, 11 patients had prior blinatumomab and prior SCT, 5 patients had prior inotuzumab ozogamicin and prior SCT, and 2 patients had prior blinatumomab, prior inotuzumab ozogamicin, and prior SCT.
Includes one patient who received autologous SCT.
BM=bone marrow; CNS=central nervous system, ECOG PS=Eastern Cooperative Oncology Group performance status; IQR=interquartile range; SCT=stem-cell transplant.