Table 1.
Patient Characteristics
| Characteristic | Cohorts 1-4 at Dose Level 3-24 units/m2 (n = 8) |
Cohorts 5-8 at Dose Level 32-76 units/m2 (n = 14) |
Cohorts 9-10 at Dose Level 101-134 units/m2 (n = 26) |
All Cohorts at Dose Level 3-134 units/m2 (N = 48) |
||||
|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | |
| Sex | ||||||||
| Male | 6 | 75.0 | 9 | 69.6 | 16 | 61.5 | 31 | 64.6 |
| Female | 2 | 25.0 | 5 | 35.7 | 10 | 38.5 | 17 | 35.4 |
| Age, years | ||||||||
| Median | 60.5 | 64 | 60.5 | 62 | ||||
| Minimum–maximum | 25-78 | 24-77 | 23-81 | 23-81 | ||||
| < 60 | 4 | 4 | 13 | 21 | ||||
| ≥ 60 | 4 | 10 | 13 | 27 | ||||
| AML | 4 | 50.0 | 13 | 92.9 | 26 | 100.0 | 43 | 89.6 |
| Primary refractory | 1 | 12.5 | 1 | 7.1 | 3 | 11.5 | 5 | 10.4 |
| 1st salvage | 2 | 25.0 | 2 | 14.3 | 14 | 58.3 | 18 | 37.5 |
| 2nd salvage | 0 | 0.0 | 5 | 35.7 | 5 | 19.2 | 10 | 20.8 |
| > 2nd salvage | 1 | 12.5 | 5 | 35.7 | 4 | 15.4 | 10 | 20.8 |
| ALL | 2 | 25.0 | 1 | 7.1 | 0 | 0.0 | 3 | 6.3 |
| MDS | 2 | 25.0 | 0 | 0.0 | 0 | 0.0 | 2 | 4.2 |
| ECOG performance status | ||||||||
| 0 | 3 | 37.5 | 3 | 21.4 | 12 | 46.2 | 18 | 37.5 |
| 1 | 4 | 50.0 | 8 | 57.1 | 13 | 50.0 | 25 | 52.1 |
| 2 | 1 | 12.5 | 3 | 21.4 | 1 | 3.8 | 5 | 10.4 |
Abbreviations: AML, acute myeloid leukemia; ALL, acute lymphoblastic leukemia; MDS, myelodysplastic syndromes; ECOG, Eastern Cooperative Oncology Group.