Table 1.
Patient characteristics by randomization
| Treatment arm | All randomized and evaluable patients in the study | ||
|---|---|---|---|
| Standard | S-HAM | P | |
| No. of patients, N (%) | 184 (48) | 203 (52) | |
| Age, years | 0.722a | ||
| Median (range) | 58 (18–86) | 58 (19–81) | |
| Sex | 0.026b | ||
| Female/male, N (%) | 76/108 (41/59) | 107/96 (53/47) | |
| Patient age (chronological), N (%) | 0.760b | ||
| <60 years | 101 (55) | 108 (53) | |
| ≥60 years | 83 (45) | 95 (47) | |
| Patient age (biological), N (%) | |||
| Younger: <60 (−70) | 119 (65) | 132 (65) | |
| Median (range) | 51 (18–68) | 52 (19–70) | 0.815a |
| Older: ≥60 (−70) | 65 (35) | 71 (35) | |
| Median (range) | 68 (60–86) | 68 (57–81) | 0.101a |
| AML subtype, N (%) | 0.091b | ||
| de novo AML | 143 (78) | 154 (76) | |
| AML secondary to MDS (s-AML) | 22 (12) | 37 (18) | |
| AML therapy-related (t-AML) | 19 (10) | 12 (6) | |
| Blasts in bone marrow, % | 0.551a | ||
| Median | 65 | 68 | |
| Range | 10‒97 | 6‒100 | |
| LDH, U/L | 0.721a | ||
| Median (range) | 334 (107–4833) | 356 (117–3431) | |
| ECOG, N (%) | 0.631b | ||
| 0 | 65 (36) | 62 (31) | |
| 1 | 94 (52) | 107 (53) | |
| 2 | 17 (9) | 23 (11) | |
| 3 | 5 (3) | 7 (4) | |
| 4 | 0 | 2 (1) | |
| Missing/unknown | 3 | 2 | |
| Karyotype, N (%) | 0.006b | ||
| Favorable | 15 (9) | 5 (3) | |
| Intermediate | 104 (65) | 146 (78) | |
| Unfavorable | 41 (26) | 37 (20) | |
| Missing/unknown | 24 | 15 | |
| Molecular aberrations, N (%) | 0.178b | ||
| NPM1 | |||
| Pos. | 53 (33) | 74 (41) | |
| Neg. | 106 (67) | 107 (59) | |
| Missing/unknown | 25 | 22 | |
| FLT3-ITD | 0.895b | ||
| Pos. | 34 (21) | 38 (21) | |
| Neg. | 125 (79) | 146 (79) | |
| Missing/unknown | 25 | 19 | |
| FLT3-TKD | 1.000b | ||
| Pos. | 11 (8) | 10 (8) | |
| Neg. | 120 (92) | 121 (92) | |
| Unknown | 53 | 72 | |
| MLL-PTD | 0.554b | ||
| Pos. | 11 (7) | 17 (9) | |
| Neg. | 143 (93) | 164 (91) | |
| Missing/unknown | 30 | 22 | |
| CEBPA | 0.676b | ||
| Pos. | 4 (11) | 2 (6) | |
| Neg. | 32 (89) | 30 (94) | |
| Missing/unknown | 148 | 171 | |
MDS myelodysplastic syndrome, LDH lactate dehydrogenase serum level, ECOG Eastern Cooperative Oncology Group, NPM1 nucleophosmin, FLT3 fms-like tyrosine kinase 3, ITD internal tandem duplication, TKD tyrosine kinase domain, MLL-PTD mixed linage leukemia-partial tandem duplication, CEBPA CCAAT/enhancer-binding protein alpha
aP-values are from Wilcoxon rank-sum test
bP-values are from Fisher’s exact test