Table 1. Patient characteristics.
| Characteristic | Number of patients (%) n = 44 |
|---|---|
| Median age (range), years | 69 (20–82) |
| ≤ 60 | 15 (34) |
| > 60 | 29 (66) |
| Sex (male/female) | 26/18 |
| ECOG performance status at screening | |
| 0 | 18 (41) |
| 1 | 21 (48) |
| 2 | 5 (11) |
| FAB classification | |
| M0 | 4 |
| M1–2 | 22 |
| M4–5 | 7 |
| M6 | 3 |
| sAML | 7 |
| Undifferentiated AML | 1 |
| Cytogenetics | |
| Number evaluable | 43 (98) |
| Intermediate risk | 31 (72) |
| Normal karyotype | 24 (56) |
| Other | 7 (16) |
| Unfavorable risk | 12 (28) |
| Complex | 6 (14) |
| Other | 6 (14) |
| FLT3 mutations | 11/37 (30) |
| ITD | 6/37 (16) |
| TKD | 5/37 (14) |
| NPM1 mutations | 8/34 (24) |
| Status | |
| Relapsed/refractory after ≥ 2 lines | 5 (11) |
| Relapsed/refractory after 1 line | 21 (48) |
| Post-transplant relapse | 11 (25) |
| Previously untreated elderly | 7 (16) |
| Median interval from diagnosis to study enrollment (range), months | 13 (0.9–130) |
Abbreviations: AML, acute myeloid leukemia; ECOG, Eastern Cooperative Oncology Group; FAB, French–American–British; ITD, internal tandem duplication; sAML, secondary acute myeloid leukemia; TKD, tyrosine kinase domain.
Patients were classified into favorable, intermediate, or unfavorable risk groups based on cytogenetics and/or molecular abnormalities. Percentages are calculated on number with evaluable cytogenetics.