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.