Table 1. Baseline Characteristics (Safety Population).
| Variable, n (%) | 55 mg/m2 (n = 9) | 70 mg/m2 (n = 19) | 90 mg/m2 (n = 8) | All (n = 36) |
|---|---|---|---|---|
| Median age (range), years | 57 (26-73) | 44 (18-68) | 69 (21-78) | 50 (18-78) |
| Age group, years | ||||
| 65-75 | 2 (22) | 3 (16) | 1 (13) | 6 (17) |
| > s75 | 0 | 0 | 3 (38) | 3 (8) |
| Female gender | 4 (44) | 7 (37) | 3 (38) | 14 (39) |
| ECOG performance status | ||||
| 0 | 0 | 7 (37) | 0 | 7 (19) |
| 1 | 7 (78) | 7 (37) | 4 (50) | 18 (50) |
| 2 | 2 (22) | 4 (21) | 4 (50) | 10 (28) |
| > 2 | 0 | 1 (5) | 0 | 1 (3) |
| Karyotypea | ||||
| Normal | 4 (44) | 2 (11) | 3 (38) | 9 (25) |
| t(v;11q23) MLL rearranged | 0 | 1 (5) | 0 | 1 (3) |
| Hyperdiploidy | 0 | 0 | 1 (13) | 1 (3) |
| Hypodiploidy | 0 | 0 | 0 | 0 |
| t(9;22)(q34;q11.2)BCR-ABL1 | 2 (22) | 3 (16) | 1 (13) | 6 (17) |
| Ph+ | 2 (22) | 3 (16) | 0 | 5 (14) |
| Ph– | 0 | 0 | 1 (13) | 1 (3) |
| t(1;19)(q23;p13.3) TCF3-PBX1 | 0 | 1 (5) | 0 | 1 (3) |
| Other abnormality | 1 (11) | 8 (42) | 1 (13) | 10 (28) |
| Not performed | 2 (22) | 5 (26) | 2 (25) | 9 (25) |
| Disease status at study entry | ||||
| Primary refractory | 3 (33) | 4 (21) | 5 (63) | 12 (33) |
| Refractory to last therapy | 1 (11) | 4 (21) | 0 | 5 (14) |
| Relapsed | 5 (56) | 11 (58) | 3 (38) | 19 (53) |
| Number of prior regimens | ||||
| 1 | 5 (56) | 5 (26) | 5 (63) | 15 (42) |
| ≥2 | 4 (44) | 14 (74) | 3 (38) | 21 (58) |
Abbreviations: ECOG = European Cooperative Oncology Group; Ph = Philadelphia chromosome.
a
Patients may have several cytogenetic abnormalities.