Patient characteristics according to randomization arm
| . | Arm A . | Arm B . | All . |
|---|---|---|---|
| Patients, n | 100 | 98 | 198 |
| CBF subset (t[8;21]/inv[16] or t[16;16]), n | 48/52 | 48/50 | 100/98 |
| Median age, y (range) | 42 (18-60) | 42 (18-59) | 42 (18-60) |
| Gender (male/female), n | 54/46 | 52/46 | 106/92 |
| Median WBC, 109/L (range) | 15.6 (0.7-232) | 14.7 (0.51-254) | 14.9 (0.7-254) |
| Median BM blasts, % (range) | 54 (9-94) | 53 (17-98) | 54 (9-98) |
| Median fusion transcript ratio, % (range) | 141 (23-947) | 171 (32-1090) | 150 (23-1090) |
| Secondary AML | 7 | 6 | 13 |
| CNS involvement | 3 | 1 | 4 |
| Additional cytogenetic abnormalities, n* | |||
| Loss of Y | 15 | 18 | 33 |
| Trisomy 8 | 7 | 10 | 17 |
| Trisomy 22 | 10 | 8 | 18 |
| del(9q) | 7 | 8 | 15 |
| del(7q)/-7 | 6 | 3 | 9 |
| Gene mutations, n† | |||
| KIT exon 8 | 10 | 8 | 18 |
| KIT exon 17 | 11 | 12 | 23 |
| KIT, all | 20 | 20 | 40 |
| FLT3-TKD | 7 | 13 | 20 |
| FLT3-ITD | 4 | 7 | 11 |
| FLT3, all | 11 | 19 | 30 |
| RTK, all | 29 | 37 | 66 |
| N-RAS | 21 | 20 | 41 |
| K-RAS | 6 | 7 | 13 |
| RAS, all | 27 | 27 | 54 |
| . | Arm A . | Arm B . | All . |
|---|---|---|---|
| Patients, n | 100 | 98 | 198 |
| CBF subset (t[8;21]/inv[16] or t[16;16]), n | 48/52 | 48/50 | 100/98 |
| Median age, y (range) | 42 (18-60) | 42 (18-59) | 42 (18-60) |
| Gender (male/female), n | 54/46 | 52/46 | 106/92 |
| Median WBC, 109/L (range) | 15.6 (0.7-232) | 14.7 (0.51-254) | 14.9 (0.7-254) |
| Median BM blasts, % (range) | 54 (9-94) | 53 (17-98) | 54 (9-98) |
| Median fusion transcript ratio, % (range) | 141 (23-947) | 171 (32-1090) | 150 (23-1090) |
| Secondary AML | 7 | 6 | 13 |
| CNS involvement | 3 | 1 | 4 |
| Additional cytogenetic abnormalities, n* | |||
| Loss of Y | 15 | 18 | 33 |
| Trisomy 8 | 7 | 10 | 17 |
| Trisomy 22 | 10 | 8 | 18 |
| del(9q) | 7 | 8 | 15 |
| del(7q)/-7 | 6 | 3 | 9 |
| Gene mutations, n† | |||
| KIT exon 8 | 10 | 8 | 18 |
| KIT exon 17 | 11 | 12 | 23 |
| KIT, all | 20 | 20 | 40 |
| FLT3-TKD | 7 | 13 | 20 |
| FLT3-ITD | 4 | 7 | 11 |
| FLT3, all | 11 | 19 | 30 |
| RTK, all | 29 | 37 | 66 |
| N-RAS | 21 | 20 | 41 |
| K-RAS | 6 | 7 | 13 |
| RAS, all | 27 | 27 | 54 |
RTK, receptor tyrosine kinase (KIT and/or FLT3).
A total of 196 the 198 patients, including 96 t(8;21) and 101 inv(16)/t(16;16) AML patients, had an available karyotype.
A total of 194 of the 198 patients, including 93 t(8;21) and 101 inv(16)/t(16;16) AML patients, were tested for KIT, FLT3 and RAS mutations.