Characteristics of the 120 patients randomized
| Characteristics . | Randomized to GO, N = 59, n (%) . | Randomized to no further therapy, N = 61, n (%) . | P . |
|---|---|---|---|
| Sex | .30 | ||
| Male | 30 (51) | 37 (61) | |
| Female | 29 (49) | 24 (39) | |
| Age, y | .62 | ||
| 0-1 | 16 (27) | 15 (25) | |
| 2-9 | 22 (37) | 28 (46) | |
| 10+ | 21 (36) | 18 (30) | |
| White blood count, × 109/L | .12 | ||
| 0-9.9 | 22 (37) | 24 (39) | |
| 10-99 | 35 (59) | 29 (48) | |
| > 100 | 2 (3) | 8 (13) | |
| FAB classification | .86 | ||
| M0 | 3 (5) | 4 (7) | |
| M1 | 7 (12) | 7 (12) | |
| M2 | 16 (27) | 22 (36) | |
| M4 | 10 (17) | 7 (12) | |
| M5 | 14 (24) | 13 (21) | |
| M6 | 1 (2) | 1 (2) | |
| M7 | 6 (10) | 4 (7) | |
| Other and missing | 2 (3) | 3 (5) | |
| CD33 expression | .07 | ||
| Positive | 50 (85) | 59 (97) | |
| Negative | 7 (12) | 2 (3) | |
| No data | 2 (3) | 0 | |
| CNS disease | .55 | ||
| Yes | 7 (12) | 6 (10) | |
| No | 51 (86) | 55 (90) | |
| Data missing | 1 (2) | 0 (0) | |
| Cytogenetics | .93 | ||
| Normal karyotype | 11 (19) | 9 (15) | |
| t(8;21) | 13 (22) | 14 (23) | |
| inv(16) | 4 (7) | 6 (10) | |
| t(9;11) | 10 (17) | 8 (13) | |
| 11q23 non t(9;11) | 6 (10) | 5 (8) | |
| Other aberrations | 15 (25) | 19 (31) | |
| FLT3 aberrations | .23 | ||
| ITD | 0 (0) | 4 (7) | |
| ALM (D835/I836) | 4 (7) | 4 (7) | |
| Wild type | 41 (70) | 37 (61) | |
| Not tested | 14 (24) | 16 (26) | |
| Risk group | .69 | ||
| Standard risk | 54 (92) | 57 (93) | |
| High risk | 5 (8) | 4 (7) | |
| Remission achieved | .22 | ||
| After first induction | 44 (75) | 51 (84) | |
| After second induction | 15 (25) | 10 (16) |
| Characteristics . | Randomized to GO, N = 59, n (%) . | Randomized to no further therapy, N = 61, n (%) . | P . |
|---|---|---|---|
| Sex | .30 | ||
| Male | 30 (51) | 37 (61) | |
| Female | 29 (49) | 24 (39) | |
| Age, y | .62 | ||
| 0-1 | 16 (27) | 15 (25) | |
| 2-9 | 22 (37) | 28 (46) | |
| 10+ | 21 (36) | 18 (30) | |
| White blood count, × 109/L | .12 | ||
| 0-9.9 | 22 (37) | 24 (39) | |
| 10-99 | 35 (59) | 29 (48) | |
| > 100 | 2 (3) | 8 (13) | |
| FAB classification | .86 | ||
| M0 | 3 (5) | 4 (7) | |
| M1 | 7 (12) | 7 (12) | |
| M2 | 16 (27) | 22 (36) | |
| M4 | 10 (17) | 7 (12) | |
| M5 | 14 (24) | 13 (21) | |
| M6 | 1 (2) | 1 (2) | |
| M7 | 6 (10) | 4 (7) | |
| Other and missing | 2 (3) | 3 (5) | |
| CD33 expression | .07 | ||
| Positive | 50 (85) | 59 (97) | |
| Negative | 7 (12) | 2 (3) | |
| No data | 2 (3) | 0 | |
| CNS disease | .55 | ||
| Yes | 7 (12) | 6 (10) | |
| No | 51 (86) | 55 (90) | |
| Data missing | 1 (2) | 0 (0) | |
| Cytogenetics | .93 | ||
| Normal karyotype | 11 (19) | 9 (15) | |
| t(8;21) | 13 (22) | 14 (23) | |
| inv(16) | 4 (7) | 6 (10) | |
| t(9;11) | 10 (17) | 8 (13) | |
| 11q23 non t(9;11) | 6 (10) | 5 (8) | |
| Other aberrations | 15 (25) | 19 (31) | |
| FLT3 aberrations | .23 | ||
| ITD | 0 (0) | 4 (7) | |
| ALM (D835/I836) | 4 (7) | 4 (7) | |
| Wild type | 41 (70) | 37 (61) | |
| Not tested | 14 (24) | 16 (26) | |
| Risk group | .69 | ||
| Standard risk | 54 (92) | 57 (93) | |
| High risk | 5 (8) | 4 (7) | |
| Remission achieved | .22 | ||
| After first induction | 44 (75) | 51 (84) | |
| After second induction | 15 (25) | 10 (16) |
GO indicates gemtuzumab ozogamicin; FAB, French-American-British; ITD, internal tandem duplication; and ALM, activation loop mutation.