Table 1. Baseline patients’ characteristics.
Data are expressed as n (%) or median [range]
| Characteristics | Population (N=40) |
|---|---|
| Age (years) | 63 [25–75] |
| Male | 21 (53) |
| Diagnosis | |
| AML | 39 (98) |
| Secondary AML | 12 (31) |
| HRMDS | 1 (2) |
| Prior regimens | 2 [1–6] |
| Int/High dose cytarabine-based | 28 (70) |
| HMA | 23 (58) |
| Clofarabine-based | 11 (28) |
| Salvage | |
| 1 | 14 (35) |
| 2 | 14 (35) |
| ≥3 | 12 (30) |
| Duration of first remission (when achieved) (months) | 11 [1–52] |
| Duration of remission on therapy received closest to clinical trial (months) | 4.3 [1–21] |
| Prior SCT | 9 (23) |
| WBC(x106 /L) | 1.8 [0.4–56] |
| Hemoglobin (g/dL) | 9.5 [7.2–14.7] |
| Platelets (x109/L) | 27 [2–231] |
| Bone marrow blasts (%) | 34 [3–95] |
| Peripheral blood blasts (%) | 11 [0–90] |
| Cytogenetics | |
| Diploid | 17 (43) |
| Complex | 16 (40) |
| −5/5q- and/or −7/7q- | 13 (33) |
| Miscellaneous | 7 (17) |
| IDH1/2 mutations | 7/37 (19) |
| RUNX1 mutation | 6/37 (16) |
| NRAS mutation | 5/39 (13) |
| TP53 mutation | 4/37 (11) |
| FLT3 mutation | 3/39 (8) |
| NPM1 mutation | 3/38 (8) |
| TET2 mutation | 2/37 (5) |
| ASXL1 mutation | 2/37 (5) |
AML: acute myeloid leukemia; HRMDS: high-risk myelodysplastic syndrome; Int: Intermediate; HMA: hypomethylating agents; SCT: stem cell transplantation; WBC: white blood cell count.