Patient characteristics
Characteristics . | AML15 . | AML17 . | ||
---|---|---|---|---|
Lestaurtinib . | Control . | Lestaurtinib . | Placebo . | |
Number randomized | 88 | 87 | 212 | 113 |
Age group, years | ||||
0-15 | 0 | 0 | 3 | 2 |
16-29 | 9 | 10 | 22 | 10 |
30-39 | 15 | 14 | 20 | 10 |
40-49 | 24 | 26 | 57 | 31 |
50-59 | 30 | 28 | 83 | 44 |
60+ | 10 | 9 | 27 | 16 |
Median (range) | 48 (16-66) | 46 (16-65) | 50 (5-68) | 50 (6-65) |
Sex | ||||
Female | 47 | 51 | 113 | 57 |
Male | 41 | 36 | 99 | 56 |
Type of disease | ||||
De novo | 84 | 84 | 198 | 104 |
Secondary | 3 | 4 | 10 | 6 |
High-risk MDS | 0 | 0 | 4 | 3 |
Performance status* | ||||
0 | 54 | 51 | 127 | 64 |
1 | 30 | 31 | 69 | 38 |
2 | 3 | 2 | 10 | 6 |
3 | 1 | 3 | 5 | 4 |
4 | 0 | 0 | 0 | 0 |
WBC | ||||
0-9.9 | 17 | 25 | 48 | 29 |
10-49.9 | 33 | 37 | 100 | 42 |
50-99.9 | 19 | 10 | 31 | 20 |
100+ | 18 | 15 | 20 | 22 |
Median (range) | 38.4 (0.2-363) | 26.0 (1.2-308.0) | 25.9 (0.8-360.0) | 30.0 (0.8-285.8) |
Cytogenetics | ||||
Favorable | 5 | 6 | 11 | 5 |
Intermediate | 64 | 69 | 190 | 97 |
Adverse | 7 | 5 | 6 | 5 |
Unknown | 12 | 7 | 5 | 6 |
Induction treatment | ||||
AML15 | ||||
ADE | 41 | 43 | ||
DA | 43 | 40 | ||
FLAG-Ida | 4 | 4 | ||
AML17 | ||||
ADE† | 38 | 21 | ||
ADE + GO3 | 17 | 9 | ||
ADE + GO6 | 26 | 13 | ||
DA + GO3 | 21 | 11 | ||
DA + GO6 | 26 | 14 | ||
DA60 | 41 | 24 | ||
DA90 | 44 | 21 | ||
SCT | ||||
Any | 47 | 39 | 89 | 51 |
In 1st CR | 33 | 29 | 46 | 25 |
Allograft | 41 | 37 | 73 | 47 |
Allo in CR1 | 32 | 27 | 40 | 23 |
FLT3 mutation status | ||||
ITD alone | 65 | 65 | 155 | 85 |
TKD alone | 22 | 18 | 52 | 23 |
ITD+TKD | 1 | 2 | 4 | 4 |
Not assessable | 0 | 2 | 1 | 1 |
FLT3 ITD mutant percentage | ||||
<25% | 18 | 22 | 55 | 31 |
25-50% | 38 | 22 | 77 | 47 |
50%+ | 5 | 14 | 27 | 11 |
Unknown | 5 | 9 | 0 | 0 |
Median | 32.5 | 36.5 | 29.5 | 31 |
Range | 5.8-92.5 | 3-98.4 | 5-98 | 3.5-96 |
NPM1c status | ||||
WT | 42 | 34 | 83 | 52 |
Mutant | 43 | 45 | 124 | 58 |
Not known | 3 | 8 | 5 | 3 |
Characteristics . | AML15 . | AML17 . | ||
---|---|---|---|---|
Lestaurtinib . | Control . | Lestaurtinib . | Placebo . | |
Number randomized | 88 | 87 | 212 | 113 |
Age group, years | ||||
0-15 | 0 | 0 | 3 | 2 |
16-29 | 9 | 10 | 22 | 10 |
30-39 | 15 | 14 | 20 | 10 |
40-49 | 24 | 26 | 57 | 31 |
50-59 | 30 | 28 | 83 | 44 |
60+ | 10 | 9 | 27 | 16 |
Median (range) | 48 (16-66) | 46 (16-65) | 50 (5-68) | 50 (6-65) |
Sex | ||||
Female | 47 | 51 | 113 | 57 |
Male | 41 | 36 | 99 | 56 |
Type of disease | ||||
De novo | 84 | 84 | 198 | 104 |
Secondary | 3 | 4 | 10 | 6 |
High-risk MDS | 0 | 0 | 4 | 3 |
Performance status* | ||||
0 | 54 | 51 | 127 | 64 |
1 | 30 | 31 | 69 | 38 |
2 | 3 | 2 | 10 | 6 |
3 | 1 | 3 | 5 | 4 |
4 | 0 | 0 | 0 | 0 |
WBC | ||||
0-9.9 | 17 | 25 | 48 | 29 |
10-49.9 | 33 | 37 | 100 | 42 |
50-99.9 | 19 | 10 | 31 | 20 |
100+ | 18 | 15 | 20 | 22 |
Median (range) | 38.4 (0.2-363) | 26.0 (1.2-308.0) | 25.9 (0.8-360.0) | 30.0 (0.8-285.8) |
Cytogenetics | ||||
Favorable | 5 | 6 | 11 | 5 |
Intermediate | 64 | 69 | 190 | 97 |
Adverse | 7 | 5 | 6 | 5 |
Unknown | 12 | 7 | 5 | 6 |
Induction treatment | ||||
AML15 | ||||
ADE | 41 | 43 | ||
DA | 43 | 40 | ||
FLAG-Ida | 4 | 4 | ||
AML17 | ||||
ADE† | 38 | 21 | ||
ADE + GO3 | 17 | 9 | ||
ADE + GO6 | 26 | 13 | ||
DA + GO3 | 21 | 11 | ||
DA + GO6 | 26 | 14 | ||
DA60 | 41 | 24 | ||
DA90 | 44 | 21 | ||
SCT | ||||
Any | 47 | 39 | 89 | 51 |
In 1st CR | 33 | 29 | 46 | 25 |
Allograft | 41 | 37 | 73 | 47 |
Allo in CR1 | 32 | 27 | 40 | 23 |
FLT3 mutation status | ||||
ITD alone | 65 | 65 | 155 | 85 |
TKD alone | 22 | 18 | 52 | 23 |
ITD+TKD | 1 | 2 | 4 | 4 |
Not assessable | 0 | 2 | 1 | 1 |
FLT3 ITD mutant percentage | ||||
<25% | 18 | 22 | 55 | 31 |
25-50% | 38 | 22 | 77 | 47 |
50%+ | 5 | 14 | 27 | 11 |
Unknown | 5 | 9 | 0 | 0 |
Median | 32.5 | 36.5 | 29.5 | 31 |
Range | 5.8-92.5 | 3-98.4 | 5-98 | 3.5-96 |
NPM1c status | ||||
WT | 42 | 34 | 83 | 52 |
Mutant | 43 | 45 | 124 | 58 |
Not known | 3 | 8 | 5 | 3 |