Baseline patient characteristics by MRD status of patients randomly assigned to IR and tested successfully for MRD
| Variable/category . | MRD− . | MRD+ . | Total . | P . |
|---|---|---|---|---|
| Patients, n | 38 | 252 | 290 | – |
| Age | ||||
| Mean (SD) | 56.4 (7.0) | 56.3 (7.4) | 56.3 (7.3) | .879 |
| Median (Q1, Q3) | 57.5 (54.0, 60.8) | 57.0 (51.8, 62.0) | 57.0 (52.0, 62.0) | |
| [Min, max] | [35.0, 67.0] | [31.0, 70.0] | [31.0, 70.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| Age, category | ||||
| <60 | 25 (65.8) | 157 (62.3) | 182 (62.8) | .723 |
| ≥60 | 13 (34.2) | 95 (37.7) | 108 (37.2) | |
| Unknown/missing | 0 | 0 | 0 | |
| Sex | ||||
| Female | 13 (34.2) | 83 (32.9) | 96 (33.1) | .855 |
| Male | 25 (65.8) | 169 (67.1) | 194 (66.9) | |
| Unknown/missing | 0 | 0 | 0 | |
| Rai stage | ||||
| Low, 0 | 2 (5.3) | 9 (3.6) | 11 (3.8) | .496 |
| Intermediate, I-II | 23 (60.5) | 136 (54.0) | 159 (54.8) | |
| High, III-IV | 13 (34.2) | 107 (42.5) | 120 (41.4) | |
| Unknown/missing | 0 | 0 | 0 | |
| ECOG PS | ||||
| 0 | 19 (50.0) | 162 (64.3) | 181 (62.4) | .234 |
| 1 | 18 (47.4) | 86 (34.1) | 104 (35.9) | |
| 2 | 1 (2.6) | 4 (1.6) | 5 (1.7) | |
| Unknown/missing | 0 | 0 | 0 | |
| Hemoglobin, g/dL | ||||
| Mean (SD) | 12.6 (2.5) | 12.2 (2.1) | 12.2 (2.2) | .180 |
| Median (Q1, Q3) | 12.8 (11.2, 14.5) | 12.3 (10.7, 13.8) | 12.4 (10.7, 14.0) | |
| [Min, max] | [6.5, 16.0] | [4.4, 17.5] | [4.4, 17.5] | |
| Freq. of missing | 0 | 2 | 2 | |
| Platelets, 103/μL | ||||
| Mean (SD) | 190.1 (85.7) | 157.8 (68.6) | 162.0 (71.7) | .051 |
| Median (Q1, Q3) | 170.5 (117.5, 246.2) | 152.0 (110.0, 197.5) | 152.5 (110.2, 201.0) | |
| [Min, max] | [68.0, 356.0] | [9.6, 508.0] | [9.6, 508.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| WBC, 103/μL | ||||
| Mean (SD) | 88.4 (129.2) | 109.8 (114.7) | 107.0 (116.7) | .016 |
| Median (Q1, Q3) | 27.2 (8.4, 109.0) | 73.6 (23.7, 161.5) | 63.2 (20.1, 156.5) | |
| [Min, max] | [4.7, 617.5] | [1.6, 597.7] | [1.6, 617.5] | |
| Freq. of missing | 0 | 0 | 0 | |
| β2-Microglobulin, mg/L | ||||
| Mean (SD) | 3.8 (2.0) | 4.0 (2.0) | 3.9 (2.0) | .443 |
| Median (Q1, Q3) | 3.3 (2.4, 4.5) | 3.6 (2.5, 4.6) | 3.6 (2.5, 4.6) | |
| [Min, max] | [1.3, 10.7] | [1.4, 14.4] | [1.3, 14.4] | |
| Freq. of missing | 0 | 2 | 2 | |
| β2-Microglobulin, category* | ||||
| Elevated | 17 (44.7) | 131 (52.4) | 148 (51.4) | .390 |
| Normal | 21 (55.3) | 119 (47.6) | 140 (48.6) | |
| Unknown/missing | 0 | 2 | 2 | |
| Serum creatinine, mg/dL | ||||
| Mean (SD) | 96.5 (7.3) | 96.5 (6.5) | 96.5 (6.6) | .658 |
| Median (Q1, Q3) | 95.0 (92.0, 97.1) | 95.1 (92.2, 99.2) | 95.1 (92.2, 98.9) | |
| [Min, max] | [88.1, 123.0] | [86.2, 123.9] | [86.2, 123.9] | |
| Freq. of missing | 0 | 0 | 0 | |
| Coombs test† | ||||
| Negative | 36 (97.3) | 229 (93.5) | 265 (94.0) | .708 |
| Positive | 1 (2.7) | 16 (6.5) | 17 (6.0) | |
| Unknown/missing | 1 | 7 | 8 | |
| Splenomegaly | ||||
| No | 30 (78.9) | 151 (59.9) | 181 (62.4) | .030 |
| Yes | 8 (21.1) | 101 (40.1) | 109 (37.6) | |
| Unknown/missing | 0 | 0 | 0 | |
| Lymphadenopathy | ||||
| No | 14 (36.8) | 70 (27.8) | 84 (29.0) | .255 |
| Yes | 24 (63.2) | 182 (72.2) | 206 (71.0) | |
| Unknown/missing | 0 | 0 | 0 | |
| Del(11q22.3) | ||||
| Abnormal | 5 (13.2) | 62 (24.7) | 67 (23.2) | .149 |
| Normal | 33 (86.8) | 189 (75.3) | 222 (76.8) | |
| Unknown/missing | 0 | 1 | 1 | |
| Dohner classification‡ | ||||
| Del(17p) | 0 (0.0) | 0 (0.0) | 0 (0.0) | .033 |
| Del(11q22) | 5 (13.2) | 62 (24.6) | 67 (23.1) | |
| Trisomy 12 | 16 (42.1) | 46 (18.3) | 62 (21.4) | |
| Normal | 5 (13.2) | 49 (19.4) | 54 (18.6) | |
| Del(13q) | 10 (26.3) | 84 (33.3) | 94 (32.4) | |
| Other | 2 (5.3) | 11 (4.4) | 13 (4.5) | |
| Unknown/missing | 0 | 0 | 0 | |
| IGHV | ||||
| Mutated | 13 (39.4) | 49 (21.9) | 62 (24.1) | .047 |
| Unmutated | 20 (60.6) | 175 (78.1) | 195 (75.9) | |
| Unknown/missing | 5 | 28 | 33 | |
| Time up and go, s§ | ||||
| Mean (SD) | 8.1 (2.6) | 8.7 (2.4) | 8.6 (2.4) | .097 |
| Median (Q1, Q3) | 8.0 (6.0, 9.8) | 9.0 (7.0, 10.0) | 9.0 (7.0, 10.0) | |
| [Min, max] | [4.0, 17.0] | [2.0, 21.0] | [2.0, 21.0] | |
| Freq. of missing | 0 | 3 | 3 | |
| CIRS | ||||
| Mean (SD) | 2.2 (2.3) | 1.9 (2.2) | 2.0 (2.2) | .580 |
| Median (Q1, Q3) | 2.0 (1.0, 2.8) | 1.0 (0.0, 3.0) | 2.0 (0.0, 3.0) | |
| [Min, max] | [0.0, 10.0] | [0.0, 14.0] | [0.0, 14.0] | |
| Freq. of missing | 8 | 28 | 36 | |
| % CD19+CD5+ cells | ||||
| Mean (SD) | 59.6 (32.1) | 78.5 (22.0) | 76.0 (24.4) | <.001 |
| Median (Q1, Q3) | 70.2 (31.1, 87.6) | 87.8 (69.1, 95.3) | 85.2 (62.8, 94.9) | |
| [Min, max] | [1.3, 97.6] | [2.8, 99.3] | [1.3, 99.3] | |
| Freq. of missing | 0 | 6 | 6 | |
| % CD38+ cells | ||||
| Mean (SD) | 47.5 (37.3) | 35.4 (32.9) | 37.0 (33.7) | .084 |
| Median (Q1, Q3) | 47.2 (8.2, 83.5) | 25.4 (4.3, 61.8) | 27.6 (4.4, 67.3) | |
| [Min, max] | [0.2, 99.9] | [0.1, 99.7] | [0.1, 99.9] | |
| Freq. of missing | 0 | 6 | 6 | |
| %CD38+ cells, category | ||||
| High (>30%) | 23 (60.5) | 114 (46.3) | 137 (48.2) | .118 |
| Low (≤30%) | 15 (39.5) | 132 (53.7) | 147 (51.8) | |
| Unknown/missing | 0 | 6 | 6 | |
| % CD49d+ cells | ||||
| Mean (SD) | 74.5 (37.8) | 43.2 (41.8) | 47.4 (42.6) | <.001 |
| Median (Q1, Q3) | 98.0 (44.6, 99.9) | 35.5 (1.2, 88.7) | 44.7 (1.5, 96.5) | |
| [Min, max] | [0.1,100.0] | [0.1,100.0] | [0.1,100.0] | |
| Freq. of missing | 0 | 6 | 6 | |
| %CD49d+ cells, category | ||||
| High (>30%) | 31 (81.6) | 124 (50.4) | 155 (54.6) | <.001 |
| Low (≤30%) | 7 (18.4) | 122 (49.6) | 129 (45.4) | |
| Unknown/missing | 0 | 6 | 6 | |
| % ZAP-70+ cells | ||||
| Mean (SD) | 21.3 (22.7) | 21.4 (21.8) | 21.4 (21.9) | .785 |
| Median (Q1, Q3) | 14.9 (2.5, 31.9) | 13.0 (4.7, 32.0) | 13.1 (4.3, 32.2) | |
| [Min, max] | [0.1, 83.6] | [0.0, 93.3] | [0.0, 93.3] | |
| Freq. of missing | 0 | 7 | 7 | |
| %ZAP-70+ cells, category | ||||
| High (>20%) | 14 (36.8) | 94 (38.4) | 108 (38.2) | 1.000 |
| Low (≤20%) | 24 (63.2) | 151 (61.6) | 175 (61.8) | |
| Unknown/missing | 0 | 7 | 7 | |
| TK (U/L) | ||||
| Mean (SD) | 36.8 (47.3) | 33.0 (37.6) | 33.5 (38.9) | 0.937 |
| Median (Q1, Q3) | 21.0 (10.0, 34.0) | 21.5 (9.6, 44.4) | 21.5 (9.6, 44.1) | |
| [Min, max] | [0.0, 207.0] | [0.0, 348.0] | [0.0, 348.0] | |
| Freq. of missing | 0 | 8 | 8 |
| Variable/category . | MRD− . | MRD+ . | Total . | P . |
|---|---|---|---|---|
| Patients, n | 38 | 252 | 290 | – |
| Age | ||||
| Mean (SD) | 56.4 (7.0) | 56.3 (7.4) | 56.3 (7.3) | .879 |
| Median (Q1, Q3) | 57.5 (54.0, 60.8) | 57.0 (51.8, 62.0) | 57.0 (52.0, 62.0) | |
| [Min, max] | [35.0, 67.0] | [31.0, 70.0] | [31.0, 70.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| Age, category | ||||
| <60 | 25 (65.8) | 157 (62.3) | 182 (62.8) | .723 |
| ≥60 | 13 (34.2) | 95 (37.7) | 108 (37.2) | |
| Unknown/missing | 0 | 0 | 0 | |
| Sex | ||||
| Female | 13 (34.2) | 83 (32.9) | 96 (33.1) | .855 |
| Male | 25 (65.8) | 169 (67.1) | 194 (66.9) | |
| Unknown/missing | 0 | 0 | 0 | |
| Rai stage | ||||
| Low, 0 | 2 (5.3) | 9 (3.6) | 11 (3.8) | .496 |
| Intermediate, I-II | 23 (60.5) | 136 (54.0) | 159 (54.8) | |
| High, III-IV | 13 (34.2) | 107 (42.5) | 120 (41.4) | |
| Unknown/missing | 0 | 0 | 0 | |
| ECOG PS | ||||
| 0 | 19 (50.0) | 162 (64.3) | 181 (62.4) | .234 |
| 1 | 18 (47.4) | 86 (34.1) | 104 (35.9) | |
| 2 | 1 (2.6) | 4 (1.6) | 5 (1.7) | |
| Unknown/missing | 0 | 0 | 0 | |
| Hemoglobin, g/dL | ||||
| Mean (SD) | 12.6 (2.5) | 12.2 (2.1) | 12.2 (2.2) | .180 |
| Median (Q1, Q3) | 12.8 (11.2, 14.5) | 12.3 (10.7, 13.8) | 12.4 (10.7, 14.0) | |
| [Min, max] | [6.5, 16.0] | [4.4, 17.5] | [4.4, 17.5] | |
| Freq. of missing | 0 | 2 | 2 | |
| Platelets, 103/μL | ||||
| Mean (SD) | 190.1 (85.7) | 157.8 (68.6) | 162.0 (71.7) | .051 |
| Median (Q1, Q3) | 170.5 (117.5, 246.2) | 152.0 (110.0, 197.5) | 152.5 (110.2, 201.0) | |
| [Min, max] | [68.0, 356.0] | [9.6, 508.0] | [9.6, 508.0] | |
| Freq. of missing | 0 | 0 | 0 | |
| WBC, 103/μL | ||||
| Mean (SD) | 88.4 (129.2) | 109.8 (114.7) | 107.0 (116.7) | .016 |
| Median (Q1, Q3) | 27.2 (8.4, 109.0) | 73.6 (23.7, 161.5) | 63.2 (20.1, 156.5) | |
| [Min, max] | [4.7, 617.5] | [1.6, 597.7] | [1.6, 617.5] | |
| Freq. of missing | 0 | 0 | 0 | |
| β2-Microglobulin, mg/L | ||||
| Mean (SD) | 3.8 (2.0) | 4.0 (2.0) | 3.9 (2.0) | .443 |
| Median (Q1, Q3) | 3.3 (2.4, 4.5) | 3.6 (2.5, 4.6) | 3.6 (2.5, 4.6) | |
| [Min, max] | [1.3, 10.7] | [1.4, 14.4] | [1.3, 14.4] | |
| Freq. of missing | 0 | 2 | 2 | |
| β2-Microglobulin, category* | ||||
| Elevated | 17 (44.7) | 131 (52.4) | 148 (51.4) | .390 |
| Normal | 21 (55.3) | 119 (47.6) | 140 (48.6) | |
| Unknown/missing | 0 | 2 | 2 | |
| Serum creatinine, mg/dL | ||||
| Mean (SD) | 96.5 (7.3) | 96.5 (6.5) | 96.5 (6.6) | .658 |
| Median (Q1, Q3) | 95.0 (92.0, 97.1) | 95.1 (92.2, 99.2) | 95.1 (92.2, 98.9) | |
| [Min, max] | [88.1, 123.0] | [86.2, 123.9] | [86.2, 123.9] | |
| Freq. of missing | 0 | 0 | 0 | |
| Coombs test† | ||||
| Negative | 36 (97.3) | 229 (93.5) | 265 (94.0) | .708 |
| Positive | 1 (2.7) | 16 (6.5) | 17 (6.0) | |
| Unknown/missing | 1 | 7 | 8 | |
| Splenomegaly | ||||
| No | 30 (78.9) | 151 (59.9) | 181 (62.4) | .030 |
| Yes | 8 (21.1) | 101 (40.1) | 109 (37.6) | |
| Unknown/missing | 0 | 0 | 0 | |
| Lymphadenopathy | ||||
| No | 14 (36.8) | 70 (27.8) | 84 (29.0) | .255 |
| Yes | 24 (63.2) | 182 (72.2) | 206 (71.0) | |
| Unknown/missing | 0 | 0 | 0 | |
| Del(11q22.3) | ||||
| Abnormal | 5 (13.2) | 62 (24.7) | 67 (23.2) | .149 |
| Normal | 33 (86.8) | 189 (75.3) | 222 (76.8) | |
| Unknown/missing | 0 | 1 | 1 | |
| Dohner classification‡ | ||||
| Del(17p) | 0 (0.0) | 0 (0.0) | 0 (0.0) | .033 |
| Del(11q22) | 5 (13.2) | 62 (24.6) | 67 (23.1) | |
| Trisomy 12 | 16 (42.1) | 46 (18.3) | 62 (21.4) | |
| Normal | 5 (13.2) | 49 (19.4) | 54 (18.6) | |
| Del(13q) | 10 (26.3) | 84 (33.3) | 94 (32.4) | |
| Other | 2 (5.3) | 11 (4.4) | 13 (4.5) | |
| Unknown/missing | 0 | 0 | 0 | |
| IGHV | ||||
| Mutated | 13 (39.4) | 49 (21.9) | 62 (24.1) | .047 |
| Unmutated | 20 (60.6) | 175 (78.1) | 195 (75.9) | |
| Unknown/missing | 5 | 28 | 33 | |
| Time up and go, s§ | ||||
| Mean (SD) | 8.1 (2.6) | 8.7 (2.4) | 8.6 (2.4) | .097 |
| Median (Q1, Q3) | 8.0 (6.0, 9.8) | 9.0 (7.0, 10.0) | 9.0 (7.0, 10.0) | |
| [Min, max] | [4.0, 17.0] | [2.0, 21.0] | [2.0, 21.0] | |
| Freq. of missing | 0 | 3 | 3 | |
| CIRS | ||||
| Mean (SD) | 2.2 (2.3) | 1.9 (2.2) | 2.0 (2.2) | .580 |
| Median (Q1, Q3) | 2.0 (1.0, 2.8) | 1.0 (0.0, 3.0) | 2.0 (0.0, 3.0) | |
| [Min, max] | [0.0, 10.0] | [0.0, 14.0] | [0.0, 14.0] | |
| Freq. of missing | 8 | 28 | 36 | |
| % CD19+CD5+ cells | ||||
| Mean (SD) | 59.6 (32.1) | 78.5 (22.0) | 76.0 (24.4) | <.001 |
| Median (Q1, Q3) | 70.2 (31.1, 87.6) | 87.8 (69.1, 95.3) | 85.2 (62.8, 94.9) | |
| [Min, max] | [1.3, 97.6] | [2.8, 99.3] | [1.3, 99.3] | |
| Freq. of missing | 0 | 6 | 6 | |
| % CD38+ cells | ||||
| Mean (SD) | 47.5 (37.3) | 35.4 (32.9) | 37.0 (33.7) | .084 |
| Median (Q1, Q3) | 47.2 (8.2, 83.5) | 25.4 (4.3, 61.8) | 27.6 (4.4, 67.3) | |
| [Min, max] | [0.2, 99.9] | [0.1, 99.7] | [0.1, 99.9] | |
| Freq. of missing | 0 | 6 | 6 | |
| %CD38+ cells, category | ||||
| High (>30%) | 23 (60.5) | 114 (46.3) | 137 (48.2) | .118 |
| Low (≤30%) | 15 (39.5) | 132 (53.7) | 147 (51.8) | |
| Unknown/missing | 0 | 6 | 6 | |
| % CD49d+ cells | ||||
| Mean (SD) | 74.5 (37.8) | 43.2 (41.8) | 47.4 (42.6) | <.001 |
| Median (Q1, Q3) | 98.0 (44.6, 99.9) | 35.5 (1.2, 88.7) | 44.7 (1.5, 96.5) | |
| [Min, max] | [0.1,100.0] | [0.1,100.0] | [0.1,100.0] | |
| Freq. of missing | 0 | 6 | 6 | |
| %CD49d+ cells, category | ||||
| High (>30%) | 31 (81.6) | 124 (50.4) | 155 (54.6) | <.001 |
| Low (≤30%) | 7 (18.4) | 122 (49.6) | 129 (45.4) | |
| Unknown/missing | 0 | 6 | 6 | |
| % ZAP-70+ cells | ||||
| Mean (SD) | 21.3 (22.7) | 21.4 (21.8) | 21.4 (21.9) | .785 |
| Median (Q1, Q3) | 14.9 (2.5, 31.9) | 13.0 (4.7, 32.0) | 13.1 (4.3, 32.2) | |
| [Min, max] | [0.1, 83.6] | [0.0, 93.3] | [0.0, 93.3] | |
| Freq. of missing | 0 | 7 | 7 | |
| %ZAP-70+ cells, category | ||||
| High (>20%) | 14 (36.8) | 94 (38.4) | 108 (38.2) | 1.000 |
| Low (≤20%) | 24 (63.2) | 151 (61.6) | 175 (61.8) | |
| Unknown/missing | 0 | 7 | 7 | |
| TK (U/L) | ||||
| Mean (SD) | 36.8 (47.3) | 33.0 (37.6) | 33.5 (38.9) | 0.937 |
| Median (Q1, Q3) | 21.0 (10.0, 34.0) | 21.5 (9.6, 44.4) | 21.5 (9.6, 44.1) | |
| [Min, max] | [0.0, 207.0] | [0.0, 348.0] | [0.0, 348.0] | |
| Freq. of missing | 0 | 8 | 8 |