Table 2.
Baseline characteristics by treatment arm.
| Characteristica | CIA (N = 48) | FIA (N = 33) |
|---|---|---|
| Age (years) | 54 (21–68) | 57 (18–69) |
| WBC (109/L) | 2.7 (0.5–59.0) | 2.3 (0.6–81.1) |
| Hemoglobin (g/dL) | 9.4 (3.7–11.4) | 9.5 (6.8–13.7) |
| Platelets (109/L) | 35 (4–320) | 25 (7–240) |
| BM blasts (%) | 34 (9–94) | 36 (9–94) |
| LDH (U/L) | 687 (300–7712) | 623 (265–8585) |
| Performance status | ||
| 0–1 | 42 (88) | 26 (79) |
| 2–3 | 5 (10) | 7 (21) |
| Unknown | 2 (4) | 0 (0) |
| Cytogenetics | ||
| Complex, −5 and/or −7 | 30 (63) | 15 (45) |
| Diploid | 11 (23) | 6 (18) |
| Others | 5 (10) | 9 (27) |
| Not done/IM | 2 (4) | 3 (9) |
| s-AML/t-AML | 15 (31) | 9 (27) |
| FLT3-ITD mutationb | 2 (6) | 3 (12) |
| Number of prior therapies | 2 (1–7) | 2 (1–5) |
| Response to last treatment | ||
| Refractory | 22 (46) | 17 (52) |
| First relapse (remission <12 months) | 6 (13) | 7 (21) |
| First relapse (remission ≥12 months) | 12 (25) | 2 (6) |
| Second or later relapse | 8 (17) | 7 (21) |
| Prior SCT | 7 (15) | 2 (6) |
a
Continuous variables are listed as median (range) and categorical variables as n (%).
b
Information on FLT3 mutation status was available in 31 and 36 patients in the CIA and FIA groups, respectively.
CIA: clofarabine, idarubicin, and cytarabine; FIA: fludarabine, idarubicin, and cytarabine; WBC:white blood cell; BM: bone marrow; LDH: lactate dehydrogenase; IM: insufficient metaphases; s-AML/t-AML: secondary/therapy-related AML; ITD: internal tandem duplication; SCT: stem cell transplantation.