Baseline characteristics in each arm
| . | FLAG-IDA (n = 82) . | CPX-351 (n = 105) . |
|---|---|---|
| Median age, y (range) | 55 (18-67) | 57 (23-70) |
| Age group | ||
| <39 | 14 (17%) | 9 (8.6%) |
| 40-49 | 12 (15%) | 16 (15%) |
| 50-59 | 34 (41%) | 51 (48%) |
| 60+ | 22 (27%) | 29 (28%) |
| Female sex | 34 (41%) | 45 (43%) |
| Diagnosis | ||
| De novo AML | 42 (51%) | 50 (48%) |
| Secondary AML | 17 (21%) | 21 (20%) |
| High-risk MDS | 23 (28%) | 34 (32%) |
| Prior history | ||
| History of previous cytotoxic/radiotherapy | 9 (11%) | 7 (6.8%) |
| History of MDS/MPN | 17 (21%) | 16 (16%) |
| WHO performance status | ||
| 0 (Normal activity) | 48 (59%) | 52 (49%) |
| 1 (Restricted activity) | 29 (35%) | 46 (44%) |
| 2 (In bed <50% waking hours) | 5 (6%) | 7 (7%) |
| Cytogenetics + FISH∗ | ||
| Complex ≥3 abnormalities | 43 (54%) | 51 (50%) |
| Complex ≥4 abnormalities | 40 (51%) | 49 (48%) |
| −5 / del5q / add5q | 32 (40%) | 45 (43%) |
| −7 / del7q / add7q | 36 (45%) | 46 (44%) |
| −17 / abn17p | 12 (15%) | 25 (24%) |
| 11q23 | 6 (8%) | 8 (7.7%) |
| 3q21 | 3 (4%) | 6 (5.8%) |
| MDS-related cytogenetics (WHO 2016) | 60 (75%) | 74 (71%) |
| Cytogenetic risk group (MRC 2010) | ||
| Adverse | 69 (84%) | 87 (83%) |
| Intermediate | 11 (13%) | 17 (16%) |
| Missing/failed | 2 (2%) | 1 (1.0%) |
| Mutations | ||
| TP53† | 32 (43%) | 43 (45%) |
| Mutation in MDS-related gene†,‡ | 38 (51%) | 37 (29%) |
| AML/MDS with MDS-related gene mutation (without comutation in TP53)†,‡ | 29 (39%) | 30 (31%) |
| 1 mutated MDS-related gene†,‡ | 10 (14%) | 8 (8%) |
| ≥2 mutated MDS-related genes†,‡ | 19 (26%) | 22 (23%) |
| NPM1 mutant | 2 (2%) | 4 (4%) |
| FLT3 TKD | 1 (1%) | 1 (1%) |
| FLT3 ITD | 4 (5%) | 4 (4%) |
| ELN 2022 risk group | ||
| Adverse | 78 (95%) | 99 (94%) |
| Intermediate | 3 (4%) | 5 (5%) |
| Missing | 1 (1%) | 1 (1%) |
| . | FLAG-IDA (n = 82) . | CPX-351 (n = 105) . |
|---|---|---|
| Median age, y (range) | 55 (18-67) | 57 (23-70) |
| Age group | ||
| <39 | 14 (17%) | 9 (8.6%) |
| 40-49 | 12 (15%) | 16 (15%) |
| 50-59 | 34 (41%) | 51 (48%) |
| 60+ | 22 (27%) | 29 (28%) |
| Female sex | 34 (41%) | 45 (43%) |
| Diagnosis | ||
| De novo AML | 42 (51%) | 50 (48%) |
| Secondary AML | 17 (21%) | 21 (20%) |
| High-risk MDS | 23 (28%) | 34 (32%) |
| Prior history | ||
| History of previous cytotoxic/radiotherapy | 9 (11%) | 7 (6.8%) |
| History of MDS/MPN | 17 (21%) | 16 (16%) |
| WHO performance status | ||
| 0 (Normal activity) | 48 (59%) | 52 (49%) |
| 1 (Restricted activity) | 29 (35%) | 46 (44%) |
| 2 (In bed <50% waking hours) | 5 (6%) | 7 (7%) |
| Cytogenetics + FISH∗ | ||
| Complex ≥3 abnormalities | 43 (54%) | 51 (50%) |
| Complex ≥4 abnormalities | 40 (51%) | 49 (48%) |
| −5 / del5q / add5q | 32 (40%) | 45 (43%) |
| −7 / del7q / add7q | 36 (45%) | 46 (44%) |
| −17 / abn17p | 12 (15%) | 25 (24%) |
| 11q23 | 6 (8%) | 8 (7.7%) |
| 3q21 | 3 (4%) | 6 (5.8%) |
| MDS-related cytogenetics (WHO 2016) | 60 (75%) | 74 (71%) |
| Cytogenetic risk group (MRC 2010) | ||
| Adverse | 69 (84%) | 87 (83%) |
| Intermediate | 11 (13%) | 17 (16%) |
| Missing/failed | 2 (2%) | 1 (1.0%) |
| Mutations | ||
| TP53† | 32 (43%) | 43 (45%) |
| Mutation in MDS-related gene†,‡ | 38 (51%) | 37 (29%) |
| AML/MDS with MDS-related gene mutation (without comutation in TP53)†,‡ | 29 (39%) | 30 (31%) |
| 1 mutated MDS-related gene†,‡ | 10 (14%) | 8 (8%) |
| ≥2 mutated MDS-related genes†,‡ | 19 (26%) | 22 (23%) |
| NPM1 mutant | 2 (2%) | 4 (4%) |
| FLT3 TKD | 1 (1%) | 1 (1%) |
| FLT3 ITD | 4 (5%) | 4 (4%) |
| ELN 2022 risk group | ||
| Adverse | 78 (95%) | 99 (94%) |
| Intermediate | 3 (4%) | 5 (5%) |
| Missing | 1 (1%) | 1 (1%) |