Patient characteristics (N = 522)
Characteristic . | SCT . | no-SCT . | P . |
---|---|---|---|
Patients | 282 | 240 | |
Trial | .42 | ||
GRAALL-2003 | 65 | 63 | |
GRAALL-2005 | 217 | 177 | |
Gender | .18 | ||
Male | 165 | 155 | |
Female | 117 | 85 | |
Age, y | .53 | ||
Median | 31.3 | 32.3 | |
Range | 16.3-55.9 | 16.6-55.9 | |
ECOG PS | .13 | ||
0 | 112 | 78 | |
1 | 146 | 134 | |
2 | 20 | 18 | |
3 | 3 | 4 | |
NA | 1 | 6 | |
ALL lineage | .71 | ||
B | 183 | 160 | |
T | 99 | 80 | |
WBC, 109/L | .30 | ||
Median | 25.0 | 18.0 | |
Range | 0.7-456 | 0.5-573 | |
Identified donor*(n= 522) | |||
Sibling | 139 | 35 | <.001 |
Unrelated | 130 | 26 | <.001 |
None | 13† | 179 | <.001 |
B-lineage ALL patients (n = 343) | |||
No. of patients | 183 | 160 | |
WBC ≥30 × 109 /L‡ | 73 | 58 | .51 |
CNS disease at diagnosis‡ | .52 | ||
Yes | 13 | 10 | |
No | 169 | 147 | |
NA | 1 | 3 | |
EGIL immunophenotype‡ | 20 | 18 | .15 |
I | 60 | 44 | |
II | 61 | 61 | |
III | 27 | 32 | |
IV | 4 | 3 | |
NA | 11 | 2 | |
t(4;11)/MLL gene rearrangement‡§ | .015 | ||
Yes | 46 | 23 | |
No | 136 | 133 | |
NA | 1 | 4 | |
t(1;19)‡ | .40 | ||
Yes | 12 | 11 | |
No | 167 | 141 | |
NA | 4 | 8 | |
Complex karyotype‡ | .09 | ||
Yes | 12 | 16 | |
No | 152 | 117 | |
NA | 19 | 27 | |
Low hypodiploidy/near triploidy‡ | .21 | ||
Yes | 7 | 13 | |
No | 160 | 131 | |
NA | 16 | 16 | |
Focal IKZF1 gene deletion | .87 | ||
Yes | 29 | 29 | |
No | 80 | 68 | |
NA | 74 | 63 | |
Resistance to steroid prephase‡ | .14 | ||
Yes | 52 | 34 | |
No | 131 | 126 | |
Poor early BM blast clearance‡ | .22 | ||
Yes | 104 | 79 | |
No | 68 | 74 | |
NA | 11 | 7 | |
Late CR‡ | .10 | ||
Yes | 10 | 3 | |
No | 173 | 155 | |
Post-induction MRD1 level ≥10−3¶ | .71 | ||
Yes | 27 | 26 | |
No | 64 | 51 | |
NA | 82 | 80 | |
T-ALL patients (n= 179) | |||
Patients | 99 | 80 | |
WBC ≥100 × 109/L | 24 | 25 | .32 |
CNS disease at diagnosis‡ | .87 | ||
Yes | 19 | 13 | |
No | 78 | 66 | |
NA | 2 | 1 | |
EGIL immunophenotype | .68 | ||
I | 6 | 2 | |
II | 42 | 31 | |
III | 33 | 27 | |
IV | 10 | 11 | |
NA | 8 | 9 | |
Complex karyotype‡ | .86 | ||
Yes | 13 | 10 | |
No | 74 | 58 | |
NA | 12 | 12 | |
TLX1 gene overexpression | .43 | ||
Yes | 11 | 9 | |
No | 69 | 49 | |
NA | 19 | 22 | |
NOTCH1/FBXW7 gene mutation | .20 | ||
Yes | 53 | 33 | |
No | 28 | 25 | |
NA | 18 | 22 | |
High-risk 4-gene classifier | .37 | ||
Yes | 35 | 34 | |
No | 37 | 22 | |
NA | 27 | 24 | |
Resistance to steroid prephase‡ | .74 | ||
Yes | 63 | 50 | |
No | 36 | 29 | |
NA | 0 | 1 | |
Poor early BM blast clearance‡ | .34 | ||
Yes | 71 | 53 | |
No | 26 | 27 | |
NA | 2 | 0 | |
Late CR‡ | .99 | ||
Yes | 3 | 3 | |
No | 96 | 77 | |
Postinduction MRD1 level ≥10−3¶ | .78 | ||
Yes | 19 | 14 | |
No | 30 | 28 | |
NA | 47 | 35 |
Characteristic . | SCT . | no-SCT . | P . |
---|---|---|---|
Patients | 282 | 240 | |
Trial | .42 | ||
GRAALL-2003 | 65 | 63 | |
GRAALL-2005 | 217 | 177 | |
Gender | .18 | ||
Male | 165 | 155 | |
Female | 117 | 85 | |
Age, y | .53 | ||
Median | 31.3 | 32.3 | |
Range | 16.3-55.9 | 16.6-55.9 | |
ECOG PS | .13 | ||
0 | 112 | 78 | |
1 | 146 | 134 | |
2 | 20 | 18 | |
3 | 3 | 4 | |
NA | 1 | 6 | |
ALL lineage | .71 | ||
B | 183 | 160 | |
T | 99 | 80 | |
WBC, 109/L | .30 | ||
Median | 25.0 | 18.0 | |
Range | 0.7-456 | 0.5-573 | |
Identified donor*(n= 522) | |||
Sibling | 139 | 35 | <.001 |
Unrelated | 130 | 26 | <.001 |
None | 13† | 179 | <.001 |
B-lineage ALL patients (n = 343) | |||
No. of patients | 183 | 160 | |
WBC ≥30 × 109 /L‡ | 73 | 58 | .51 |
CNS disease at diagnosis‡ | .52 | ||
Yes | 13 | 10 | |
No | 169 | 147 | |
NA | 1 | 3 | |
EGIL immunophenotype‡ | 20 | 18 | .15 |
I | 60 | 44 | |
II | 61 | 61 | |
III | 27 | 32 | |
IV | 4 | 3 | |
NA | 11 | 2 | |
t(4;11)/MLL gene rearrangement‡§ | .015 | ||
Yes | 46 | 23 | |
No | 136 | 133 | |
NA | 1 | 4 | |
t(1;19)‡ | .40 | ||
Yes | 12 | 11 | |
No | 167 | 141 | |
NA | 4 | 8 | |
Complex karyotype‡ | .09 | ||
Yes | 12 | 16 | |
No | 152 | 117 | |
NA | 19 | 27 | |
Low hypodiploidy/near triploidy‡ | .21 | ||
Yes | 7 | 13 | |
No | 160 | 131 | |
NA | 16 | 16 | |
Focal IKZF1 gene deletion | .87 | ||
Yes | 29 | 29 | |
No | 80 | 68 | |
NA | 74 | 63 | |
Resistance to steroid prephase‡ | .14 | ||
Yes | 52 | 34 | |
No | 131 | 126 | |
Poor early BM blast clearance‡ | .22 | ||
Yes | 104 | 79 | |
No | 68 | 74 | |
NA | 11 | 7 | |
Late CR‡ | .10 | ||
Yes | 10 | 3 | |
No | 173 | 155 | |
Post-induction MRD1 level ≥10−3¶ | .71 | ||
Yes | 27 | 26 | |
No | 64 | 51 | |
NA | 82 | 80 | |
T-ALL patients (n= 179) | |||
Patients | 99 | 80 | |
WBC ≥100 × 109/L | 24 | 25 | .32 |
CNS disease at diagnosis‡ | .87 | ||
Yes | 19 | 13 | |
No | 78 | 66 | |
NA | 2 | 1 | |
EGIL immunophenotype | .68 | ||
I | 6 | 2 | |
II | 42 | 31 | |
III | 33 | 27 | |
IV | 10 | 11 | |
NA | 8 | 9 | |
Complex karyotype‡ | .86 | ||
Yes | 13 | 10 | |
No | 74 | 58 | |
NA | 12 | 12 | |
TLX1 gene overexpression | .43 | ||
Yes | 11 | 9 | |
No | 69 | 49 | |
NA | 19 | 22 | |
NOTCH1/FBXW7 gene mutation | .20 | ||
Yes | 53 | 33 | |
No | 28 | 25 | |
NA | 18 | 22 | |
High-risk 4-gene classifier | .37 | ||
Yes | 35 | 34 | |
No | 37 | 22 | |
NA | 27 | 24 | |
Resistance to steroid prephase‡ | .74 | ||
Yes | 63 | 50 | |
No | 36 | 29 | |
NA | 0 | 1 | |
Poor early BM blast clearance‡ | .34 | ||
Yes | 71 | 53 | |
No | 26 | 27 | |
NA | 2 | 0 | |
Late CR‡ | .99 | ||
Yes | 3 | 3 | |
No | 96 | 77 | |
Postinduction MRD1 level ≥10−3¶ | .78 | ||
Yes | 19 | 14 | |
No | 30 | 28 | |
NA | 47 | 35 |
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; EGIL, European Group for the Immunological Characterization of Leukemias; NA, not applicable; WBC, white blood cell count.
Numbers of patients with a donor identified by the GRAALL-2003 or GRAALL-2005 protocol criteria (supplemental Data).
These 13 patients received cord blood SCT.
Conventional high-risk factor used in the GRAALL trials.
59 of the 69 patients with MLL gene rearrangement had t(4;11) translocation.
In patients who reached hematologic CR after the first induction cycle.