Demographics of patients enrolled in AML19v2 trial, including those in the Midotarg substudy receiving DAGO+m and those receiving DAGO alone
| . | Midotarg substudy . | Other patients enrolled in AML19v2 . | ||||
|---|---|---|---|---|---|---|
| Total . | DAGO1+m . | DAGO2+m . | Total . | DAGO1 . | DAGO2 . | |
| n | 77 | 39 | 38 | 118 | 58 | 60 |
| Median age (range), y | 51 (20-74) | 52 (21-74) | 50 (20-72) | 50 (17-65) | 48 (18-64) | 50 (17-65) |
| Age group, y | ||||||
| <30 | 5 (6.5) | 2 (5.1) | 3 (7.9) | 14 (11.9) | 8 (13.8) | 6 (10.0) |
| 30-39 | 13 (16.9) | 6 (15.4) | 7 (18.4) | 17 (14.4) | 9 (15.5) | 8 (13.3) |
| 40-49 | 19 (24.7) | 10 (25.6) | 9 (23.7) | 25 (21.2) | 11 (19.0) | 14 (23.3) |
| 50-59 | 24 (31.2) | 13 (33.3) | 11 (28.9) | 49 (41.5) | 23 (39.7) | 26 (43.3) |
| ≥60 | 16 (20.8) | 8 (20.5) | 8 (21.1) | 13 (11) | 7 (12.1) | 6 (10.0) |
| Gender | ||||||
| Male | 37 (48.1) | 19 (48.7) | 18 (47.4) | 58 (49.2) | 29 (50.0) | 29 (48.3) |
| Female | 40 (51.9) | 20 (51.3) | 20 (52.6) | 60 (50.8) | 29 (50.0) | 31 (51.7) |
| Previous hematological disorder | 1 (1.3) | 1 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Previous chemotherapy or radiotherapy | 1 (1.3) | 1 (2.6) | 0 (0.0) | 3 (2.6) | 2 (3.6) | 1 (1.7) |
| WBC count, ×109/L | ||||||
| <10 | 27 (35.1) | 14 (35.9) | 13 (34.2) | 60 (50.8) | 28 (48.3) | 32 (53.3) |
| 10 to <50 | 36 (46.8) | 18 (46.2) | 18 (47.4) | 47 (39.8) | 24 (41.4) | 23 (38.3) |
| 50 to <100 | 7 (9.1) | 4 (10.3) | 3 (7.9) | 9 (7.6) | 5 (8.6) | 4 (6.7) |
| ≥100 | 7 (9.1) | 3 (7.7) | 4 (10.5) | 2 (1.7) | 1 (1.7) | 1 (1.7) |
| WHO performance status | ||||||
| Normal activity | 36 (46.8) | 18 (46.2) | 18 (47.4) | 68 (57.6) | 34 (58.6) | 34 (56.7) |
| Restricted activity | 37 (48.1) | 19 (48.7) | 18 (47.4) | 43 (36.4) | 21 (36.2) | 22 (36.7) |
| In bed <50% waking hours | 4 (5.2) | 2 (5.1) | 2 (5.3) | 7 (5.9) | 3 (5.2) | 4 (6.7) |
| FLT3-ITD mutation | 60 (77.9) | 29 (74.4) | 31 (81.6) | 3 (2.6) | 2 (3.5) | 1 (1.7) |
| FLT3-ITD AR, median (IQR) | 0.46 (0.16-0.74) | 0.45 (0.13-0.71) | 0.48 (0.23-0.78) | 0.70 (0.36-0.735) | 0.74 (0.70-0.77) | 0.02 (0.02-0.02) |
| FLT3-TKD mutation | 22 (28.6) | 12 (30.8) | 10 (26.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| NPM1 mutation | 49 (63.6) | 25 (64.1) | 24 (63.2) | 32 (27.4) | 16 (28.1) | 16 (26.7) |
| Cytogenetics (Grimwade et al11) | ||||||
| CBF | 6 (7.8) | 2 (5.1) | 4 (10.5) | 21 (17.8) | 11 (19.0) | 10 (16.7) |
| Normal | 41 (53.2) | 18 (46.2) | 23 (60.5) | 53 (44.9) | 30 (51.7) | 23 (38.3) |
| Other intermediate | 23 (29.9) | 15 (38.5) | 8 (21.1) | 23 (19.5) | 10 (17.2) | 13 (21.7) |
| Adverse | 1 (1.3) | 1 (2.6) | 0 (0.0) | 17 (14.4) | 7 (12.1) | 10 (16.7) |
| Failed | 6 (7.8) | 3 (7.7) | 3 (7.9) | 4 (3.3) | 0 (0.0) | 4 (6.7) |
| . | Midotarg substudy . | Other patients enrolled in AML19v2 . | ||||
|---|---|---|---|---|---|---|
| Total . | DAGO1+m . | DAGO2+m . | Total . | DAGO1 . | DAGO2 . | |
| n | 77 | 39 | 38 | 118 | 58 | 60 |
| Median age (range), y | 51 (20-74) | 52 (21-74) | 50 (20-72) | 50 (17-65) | 48 (18-64) | 50 (17-65) |
| Age group, y | ||||||
| <30 | 5 (6.5) | 2 (5.1) | 3 (7.9) | 14 (11.9) | 8 (13.8) | 6 (10.0) |
| 30-39 | 13 (16.9) | 6 (15.4) | 7 (18.4) | 17 (14.4) | 9 (15.5) | 8 (13.3) |
| 40-49 | 19 (24.7) | 10 (25.6) | 9 (23.7) | 25 (21.2) | 11 (19.0) | 14 (23.3) |
| 50-59 | 24 (31.2) | 13 (33.3) | 11 (28.9) | 49 (41.5) | 23 (39.7) | 26 (43.3) |
| ≥60 | 16 (20.8) | 8 (20.5) | 8 (21.1) | 13 (11) | 7 (12.1) | 6 (10.0) |
| Gender | ||||||
| Male | 37 (48.1) | 19 (48.7) | 18 (47.4) | 58 (49.2) | 29 (50.0) | 29 (48.3) |
| Female | 40 (51.9) | 20 (51.3) | 20 (52.6) | 60 (50.8) | 29 (50.0) | 31 (51.7) |
| Previous hematological disorder | 1 (1.3) | 1 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Previous chemotherapy or radiotherapy | 1 (1.3) | 1 (2.6) | 0 (0.0) | 3 (2.6) | 2 (3.6) | 1 (1.7) |
| WBC count, ×109/L | ||||||
| <10 | 27 (35.1) | 14 (35.9) | 13 (34.2) | 60 (50.8) | 28 (48.3) | 32 (53.3) |
| 10 to <50 | 36 (46.8) | 18 (46.2) | 18 (47.4) | 47 (39.8) | 24 (41.4) | 23 (38.3) |
| 50 to <100 | 7 (9.1) | 4 (10.3) | 3 (7.9) | 9 (7.6) | 5 (8.6) | 4 (6.7) |
| ≥100 | 7 (9.1) | 3 (7.7) | 4 (10.5) | 2 (1.7) | 1 (1.7) | 1 (1.7) |
| WHO performance status | ||||||
| Normal activity | 36 (46.8) | 18 (46.2) | 18 (47.4) | 68 (57.6) | 34 (58.6) | 34 (56.7) |
| Restricted activity | 37 (48.1) | 19 (48.7) | 18 (47.4) | 43 (36.4) | 21 (36.2) | 22 (36.7) |
| In bed <50% waking hours | 4 (5.2) | 2 (5.1) | 2 (5.3) | 7 (5.9) | 3 (5.2) | 4 (6.7) |
| FLT3-ITD mutation | 60 (77.9) | 29 (74.4) | 31 (81.6) | 3 (2.6) | 2 (3.5) | 1 (1.7) |
| FLT3-ITD AR, median (IQR) | 0.46 (0.16-0.74) | 0.45 (0.13-0.71) | 0.48 (0.23-0.78) | 0.70 (0.36-0.735) | 0.74 (0.70-0.77) | 0.02 (0.02-0.02) |
| FLT3-TKD mutation | 22 (28.6) | 12 (30.8) | 10 (26.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| NPM1 mutation | 49 (63.6) | 25 (64.1) | 24 (63.2) | 32 (27.4) | 16 (28.1) | 16 (26.7) |
| Cytogenetics (Grimwade et al11) | ||||||
| CBF | 6 (7.8) | 2 (5.1) | 4 (10.5) | 21 (17.8) | 11 (19.0) | 10 (16.7) |
| Normal | 41 (53.2) | 18 (46.2) | 23 (60.5) | 53 (44.9) | 30 (51.7) | 23 (38.3) |
| Other intermediate | 23 (29.9) | 15 (38.5) | 8 (21.1) | 23 (19.5) | 10 (17.2) | 13 (21.7) |
| Adverse | 1 (1.3) | 1 (2.6) | 0 (0.0) | 17 (14.4) | 7 (12.1) | 10 (16.7) |
| Failed | 6 (7.8) | 3 (7.7) | 3 (7.9) | 4 (3.3) | 0 (0.0) | 4 (6.7) |
Data are presented as n (%) unless otherwise specified.
IQR, interquartile range; TKD, tyrosine kinase domain; WBC, white blood cell.