Relationship between IKZF1 lesions and baseline characteristics for both PCR and MLPA methods
| . | IKZF1 WT . | ΔIKZF1* . | IKZF1 plus* . | P† . | ΔIKZF1 LOF . | ΔIKZF1 DN . | P† . |
|---|---|---|---|---|---|---|---|
| PCR-determined | N = 384 | N = 114 | Deleted vs WT | N = 48 | N = 66 | ||
| Age, median (range), y | 45.0 (23-65) | 48.0 (25-65) | .13 | 47.5 (25-64) | 48.0 (26-65) | .46/.13 | |
| Age over 40 y at randomization, N (%) | 240 (62.5) | 75 (65.8) | .52 | 31 (64.6) | 44 (66.7) | .78/.52 | |
| Male sex,‡ N (%) | 212 (55.2) | 58 (50.9) | .40 | 28 (58.3) | 30 (45.5) | .70/.14 | |
| ECOG 0, N (%) | 236 (62.1) | 68 (59.6) | .63 | 24 (50.0) | 44 (66.7) | .10/.48 | |
| Baseline WBC (range x 109/L) | 8.5 (0.11-889.6) | 14.3 (0.6-341.28) | .016 | 14.1 (1.6-223.7) | 15.0 (0.6-341.28) | .059/.079 | |
| Genetic subtype, N (%) | |||||||
| BCR-ABL1 | 98 (25.5) | 69 (60.5) | <.0001 | 29 (60.4) | 40 (60.6) | <.0001/<.0001 | |
| Complex karyotype | 15 (3.9) | 2 (1.8) | .58 | 0 | 2 (3.0) | .71/.7 5 | |
| Failed/no data | 50 (13.0) | 6 (5.3) | NA | 2 (4.2) | 4 (6.1) | NA | |
| High hyperdiploid | 10 (2.6) | 0 | NA | 0 | 0 | NA | |
| JAK-STAT | 10 (2.6) | 16 (14.0) | NA | 10 (20.8) | 6 (9.1) | NA | |
| KMT2A other | 7 (1.8) | 0 | NA | 0 | 0 | NA | |
| KMT2A-AFF1 | 41 (10.7) | 1 (0.9) | .001 | 0 | 1 (1.5) | .008/.011 | |
| Low hypodiploid/Near triploid | 35 (9.1) | 1 (0.9) | .002 | 0 | 1 (1.5) | .022/.027 | |
| Other | 104 (27.1) | 19 (16.7) | NA | 7 (14.6) | 12 (18.2) | NA | |
| TCF3-PBX1 | 14 (3.6) | 0 | NA | 0 | 0 | NA | |
| UKALL14 high risk, N (%) | 319 (83.1) | 101 (88.6) | .57 | 43 (89.6) | 58 (87.9) | .48/.18 | |
| MLPA-determined x 109/L | N = 235 | N = 66 | N = 83 | Deleted vs WT/ IKZF1plus vs WT | N = 100 | N = 46 | LOF vs WT/ DN vs WT |
| Age, median (range), y | 44.0 (23-65) | 43.0 (25-64) | 49.0 (25-65) | .69/.0017 | 45.0 (25-63) | 49.0 (26-65) | .14/0.099 |
| Age over 40 y at randomization, N (%) | 154 (57.9) | 44 (57.1) | 66 (71.0) | .91/.0026 | 73 (63.5) | 36 (69.2) | .31/.13 |
| Male sex,‡ N (%) | 143 (53.8) | 47 (61.0) | 49 (52.7) | .27/.83 | 69 (60.0) | 26 (50.0) | .28/.60 |
| ECOG 0, N (%) | 158 (60.1) | 47 (61.0) | 61 (65.6) | .88/.35 | 68 (59.1) | 37 (71.2) | .86/.13 |
| Baseline WBC (range) | 7.9 (0.11-889.6) | 15.5 (1.1-213) | 19.8 (0.6-453.9) | .037/.0023 | 18.2 (0.9-453.9) | 14.7 (0.6-213) | .0003/.27 |
| Genetic subtype, N (%) | |||||||
| BCR-ABL1 | 56 (21.1) | 49 (63.6) | 49 (52.7) | <.0001/<.0001 | 64 (55.7) | 32 (61.5) | <.0001/<.0001 |
| Complex karyotype | 11 (4.1) | 0 | 3 (3.2) | .31/.57 | 1 (0.9) | 2 (3.8) | >.99> |
| Failed/no data | 38 (14.3) | 4 (5.2) | 5 (5.4) | NA | 5 (4.3) | 4 (7.7) | NA |
| High hyperdiploid | 9 (3.4) | 0 | 0 | NA | 0 | 0 | NA |
| JAK-STAT | 7 (2.6) | 5 (6.5) | 14 (15.1) | NA | 15 (13.0) | 4 (7.7) | NA |
| KMT2A other | 5 (1.9) | 1 (1.3) | 0 | NA | 1 (0.9) | 0 | NA |
| KMT2A-AFF1 | 38 (14.3) | 1 (1.3) | 1 (1.1) | <.0001/<.0001 | 1 (0.9) | 0 | <.0001./.001 |
| Low hypodiploid/near-triploid | 2 (0.8) | 0 | 1 (1.1) | >.99> | 1 (0.9) | 0 | >.99> |
| Other | 88 (33.1) | 16 (20.8) | 19 (20.4) | NA | 25 (21.7) | 10 (19.2) | NA |
| TCF3-PBX1 | 12 (4.5) | 1 (1.3) | 1 (1.1) | NA | 2 (1.7) | 0 | NA |
| UKALL14 high risk baseline | 206 (77.4) | 65 (84.4) | 85 (91.4) | .14/.009 | 206 (77.4) | 65 (84.4) | .34/.090 |
| . | IKZF1 WT . | ΔIKZF1* . | IKZF1 plus* . | P† . | ΔIKZF1 LOF . | ΔIKZF1 DN . | P† . |
|---|---|---|---|---|---|---|---|
| PCR-determined | N = 384 | N = 114 | Deleted vs WT | N = 48 | N = 66 | ||
| Age, median (range), y | 45.0 (23-65) | 48.0 (25-65) | .13 | 47.5 (25-64) | 48.0 (26-65) | .46/.13 | |
| Age over 40 y at randomization, N (%) | 240 (62.5) | 75 (65.8) | .52 | 31 (64.6) | 44 (66.7) | .78/.52 | |
| Male sex,‡ N (%) | 212 (55.2) | 58 (50.9) | .40 | 28 (58.3) | 30 (45.5) | .70/.14 | |
| ECOG 0, N (%) | 236 (62.1) | 68 (59.6) | .63 | 24 (50.0) | 44 (66.7) | .10/.48 | |
| Baseline WBC (range x 109/L) | 8.5 (0.11-889.6) | 14.3 (0.6-341.28) | .016 | 14.1 (1.6-223.7) | 15.0 (0.6-341.28) | .059/.079 | |
| Genetic subtype, N (%) | |||||||
| BCR-ABL1 | 98 (25.5) | 69 (60.5) | <.0001 | 29 (60.4) | 40 (60.6) | <.0001/<.0001 | |
| Complex karyotype | 15 (3.9) | 2 (1.8) | .58 | 0 | 2 (3.0) | .71/.7 5 | |
| Failed/no data | 50 (13.0) | 6 (5.3) | NA | 2 (4.2) | 4 (6.1) | NA | |
| High hyperdiploid | 10 (2.6) | 0 | NA | 0 | 0 | NA | |
| JAK-STAT | 10 (2.6) | 16 (14.0) | NA | 10 (20.8) | 6 (9.1) | NA | |
| KMT2A other | 7 (1.8) | 0 | NA | 0 | 0 | NA | |
| KMT2A-AFF1 | 41 (10.7) | 1 (0.9) | .001 | 0 | 1 (1.5) | .008/.011 | |
| Low hypodiploid/Near triploid | 35 (9.1) | 1 (0.9) | .002 | 0 | 1 (1.5) | .022/.027 | |
| Other | 104 (27.1) | 19 (16.7) | NA | 7 (14.6) | 12 (18.2) | NA | |
| TCF3-PBX1 | 14 (3.6) | 0 | NA | 0 | 0 | NA | |
| UKALL14 high risk, N (%) | 319 (83.1) | 101 (88.6) | .57 | 43 (89.6) | 58 (87.9) | .48/.18 | |
| MLPA-determined x 109/L | N = 235 | N = 66 | N = 83 | Deleted vs WT/ IKZF1plus vs WT | N = 100 | N = 46 | LOF vs WT/ DN vs WT |
| Age, median (range), y | 44.0 (23-65) | 43.0 (25-64) | 49.0 (25-65) | .69/.0017 | 45.0 (25-63) | 49.0 (26-65) | .14/0.099 |
| Age over 40 y at randomization, N (%) | 154 (57.9) | 44 (57.1) | 66 (71.0) | .91/.0026 | 73 (63.5) | 36 (69.2) | .31/.13 |
| Male sex,‡ N (%) | 143 (53.8) | 47 (61.0) | 49 (52.7) | .27/.83 | 69 (60.0) | 26 (50.0) | .28/.60 |
| ECOG 0, N (%) | 158 (60.1) | 47 (61.0) | 61 (65.6) | .88/.35 | 68 (59.1) | 37 (71.2) | .86/.13 |
| Baseline WBC (range) | 7.9 (0.11-889.6) | 15.5 (1.1-213) | 19.8 (0.6-453.9) | .037/.0023 | 18.2 (0.9-453.9) | 14.7 (0.6-213) | .0003/.27 |
| Genetic subtype, N (%) | |||||||
| BCR-ABL1 | 56 (21.1) | 49 (63.6) | 49 (52.7) | <.0001/<.0001 | 64 (55.7) | 32 (61.5) | <.0001/<.0001 |
| Complex karyotype | 11 (4.1) | 0 | 3 (3.2) | .31/.57 | 1 (0.9) | 2 (3.8) | >.99> |
| Failed/no data | 38 (14.3) | 4 (5.2) | 5 (5.4) | NA | 5 (4.3) | 4 (7.7) | NA |
| High hyperdiploid | 9 (3.4) | 0 | 0 | NA | 0 | 0 | NA |
| JAK-STAT | 7 (2.6) | 5 (6.5) | 14 (15.1) | NA | 15 (13.0) | 4 (7.7) | NA |
| KMT2A other | 5 (1.9) | 1 (1.3) | 0 | NA | 1 (0.9) | 0 | NA |
| KMT2A-AFF1 | 38 (14.3) | 1 (1.3) | 1 (1.1) | <.0001/<.0001 | 1 (0.9) | 0 | <.0001./.001 |
| Low hypodiploid/near-triploid | 2 (0.8) | 0 | 1 (1.1) | >.99> | 1 (0.9) | 0 | >.99> |
| Other | 88 (33.1) | 16 (20.8) | 19 (20.4) | NA | 25 (21.7) | 10 (19.2) | NA |
| TCF3-PBX1 | 12 (4.5) | 1 (1.3) | 1 (1.1) | NA | 2 (1.7) | 0 | NA |
| UKALL14 high risk baseline | 206 (77.4) | 65 (84.4) | 85 (91.4) | .14/.009 | 206 (77.4) | 65 (84.4) | .34/.090 |
See Table 1 for expansion of abbreviations.
IKZF1 and IKZF1plus are mutually exclusive categories in this table.
P values are χ2 for binary variables and Wilcoxon-Mann-Whitney for continuous.
One intersex patient (genetically male but identified as female) has been excluded from all comparisons by sex.