Demographic and biologic characteristics of 55 adults with relapsed and refractory acute leukemia
| . | Dose escalation (n = 36) . | Expansion (n = 19) . | Total (n = 55) . |
|---|---|---|---|
| Sex | |||
| Male | 16 (44%) | 9 (47%) | 25 (45%) |
| Female | 20 (56%) | 10 (53%) | 30 (55%) |
| Median age, y (range) | 56 (20-72) | 51 (22-69) | 54 (20-72) |
| AML | 31 (86%) | 18 (95%) | 49 (89%) |
| Relapse | 7 | 5 | 12* |
| Primary refractory | 13 | 4 | 17 |
| Multirefractory | 10 | 6 | 16 |
| MPD/AML | 1 | 4 | 5 |
| ALL | 3 (8%) | 0 (0%) | 3 (5%) |
| Biphenotypic T/AML (ABL) | 2 (6%) | 1 (5%) | 3 (5%) |
| Prior regimens, median (range) | 2 (1-4) | 3 (1-4) | 2 (1-4) |
| Prior drug exposure, n (%) | |||
| Ara-C | 28 (77%) | 16 (84%) | 44 (80%) |
| HiDAc | 14 | 8 | 22 |
| 2 g/m2 per 72 hours | 11 | 5 | 16 |
| Prior allogeneic SCT | 8 | 1 | 9 |
| Adverse genetics | 29 (81%) | 12 (63%) | 41 (75%) |
| AML | 26 | 11 | 37 (67%) |
| Single cytogenetics | 11 | 3 | 14 |
| Complex cytogenetics | 11 | 6 | 17 |
| FLT3 mutation | 4 | 3 | 7 |
| ALL | 2 | 0 | 2 (66%) |
| ABL | 1 | 1 | 2 (66%) |
| . | Dose escalation (n = 36) . | Expansion (n = 19) . | Total (n = 55) . |
|---|---|---|---|
| Sex | |||
| Male | 16 (44%) | 9 (47%) | 25 (45%) |
| Female | 20 (56%) | 10 (53%) | 30 (55%) |
| Median age, y (range) | 56 (20-72) | 51 (22-69) | 54 (20-72) |
| AML | 31 (86%) | 18 (95%) | 49 (89%) |
| Relapse | 7 | 5 | 12* |
| Primary refractory | 13 | 4 | 17 |
| Multirefractory | 10 | 6 | 16 |
| MPD/AML | 1 | 4 | 5 |
| ALL | 3 (8%) | 0 (0%) | 3 (5%) |
| Biphenotypic T/AML (ABL) | 2 (6%) | 1 (5%) | 3 (5%) |
| Prior regimens, median (range) | 2 (1-4) | 3 (1-4) | 2 (1-4) |
| Prior drug exposure, n (%) | |||
| Ara-C | 28 (77%) | 16 (84%) | 44 (80%) |
| HiDAc | 14 | 8 | 22 |
| 2 g/m2 per 72 hours | 11 | 5 | 16 |
| Prior allogeneic SCT | 8 | 1 | 9 |
| Adverse genetics | 29 (81%) | 12 (63%) | 41 (75%) |
| AML | 26 | 11 | 37 (67%) |
| Single cytogenetics | 11 | 3 | 14 |
| Complex cytogenetics | 11 | 6 | 17 |
| FLT3 mutation | 4 | 3 | 7 |
| ALL | 2 | 0 | 2 (66%) |
| ABL | 1 | 1 | 2 (66%) |
HiDAc indicates high-dose Ara-C; and SCT, stem cell transplantation (all performed in AML patients).
Relapse: 7 CR1 (2 after BMT), median, 11 months (range, 7-18 months); 4 ≥ CR2 (3 after BMT), median 7 months (range, 3-12 months).