Baseline patient characteristics of patients with sustained uMRD levels
| Characteristic . | Clb-Obi . | Ven-Obi . | All other patients [ITT] . |
|---|---|---|---|
| (N = 4) . | (N = 17) . | (N = 411) . | |
| Age (y) | |||
| Median (range) | 72.5 (67-85) | 73 (54-83) | 72 (41-89) |
| ≥75, n (%) | 2 (50.0) | 5 (29.4) | 143 (34.8) |
| Male sex, n (%) | 3 (75.0) | 10 (58.8) | 276 (67.2) |
| Binet stage, n (%) | |||
| A | 2 (50.0) | 3 (17.6) | 85 (20.7) |
| B | 0 (0.0) | 8 (47.1) | 148 (36.0) |
| C | 2 (50.0) | 6 (35.3) | 178 (43.3) |
| B-symptoms present, n (%) | 1 (25.0) | 9 (52.9) | 205 (49.9) |
| Total CIRS score | |||
| Median (range) | 4 (1-12) | 9 (4-16) | 8 (0-28) |
| >6, n (%) | 2 (50.0) | 16 (94.1) | 345 (83.9) |
| Serum β2-microglobulin (mg/L) | |||
| Median (range) | 4.8 (2.7-8.7) | 3.6 (1.5-7.7) | 4.1 (1.0-14.2) |
| >3.5, n (%) | 3 (75.0) | 9 (52.9) | 236/388 (60.8) |
| Estimated creatinine clearance (mL/min) | |||
| Median (range) | 57.7 (34.0-69.2) | 65.0 (35.6-152.6) | 66.6 (25.1-295.6) |
| <70, n (%) | 4 (100.0) | 10 (58.8) | 234/407 (57.5) |
| Cytogenetic subgroups as per hierarchy,∗ n (%) | |||
| Deletion in 17p | 0 (0.0) | 0 (0.0) | 31/418 (7.4) |
| Deletion in 11q | 1 (25.0) | 1 (5.9) | 74/418 (17.7) |
| Trisomy in 12 | 0 (0.0) | 1 (5.9) | 76/418 (18.2) |
| No abnormalities | 1 (25.0) | 3 (17.6) | 92/418 (22.0) |
| Deletion in 13q∗ alone | 2 (50.0) | 12 (70.6) | 145/418 (34.7) |
| IGHV mutational status,∗ n (%) | |||
| Mutated | 2 (50.0) | 15 (88.2) | 142/387 (36.7) |
| Unmutated | 2 (50.0) | 2 (11.8) | 240/387 (62.0) |
| Nonevaluable | 0 (0.0) | 0 (0.0) | 5/387 (1.3) |
| TP53 mutational status, n (%) | |||
| Mutated | 1 (25.0) | 2 (11.8) | 39/400 (9.8) |
| Unmutated | 3 (75.0) | 15 (88.2) | 361/400 (90.3) |
| TP53 deleted and/or mutated, n (%) | 1 (25.0) | 2 (11.8) | 46/396 (11.6) |
| CLL-IPI risk group, n (%) | |||
| Low | 1 (25.0) | 4 (23.5) | 30/360 (8.3) |
| Intermediate | 1 (25.0) | 4 (23.5) | 90/360 (25.0) |
| High | 1 (25.0) | 7 (41.2) | 202/360 (56.1) |
| Very high | 1 (25.0) | 2 (11.8) | 38/360 (10.6) |
| Complex karyotype group, n (%) | |||
| NCKT | 4 (100.0) | 14/15 (93.3) | 315/378 (83.3) |
| CKT/HCKT | 0 (0.0) | 1/15 (6.7) | 63/378 (16.7) |
| Characteristic . | Clb-Obi . | Ven-Obi . | All other patients [ITT] . |
|---|---|---|---|
| (N = 4) . | (N = 17) . | (N = 411) . | |
| Age (y) | |||
| Median (range) | 72.5 (67-85) | 73 (54-83) | 72 (41-89) |
| ≥75, n (%) | 2 (50.0) | 5 (29.4) | 143 (34.8) |
| Male sex, n (%) | 3 (75.0) | 10 (58.8) | 276 (67.2) |
| Binet stage, n (%) | |||
| A | 2 (50.0) | 3 (17.6) | 85 (20.7) |
| B | 0 (0.0) | 8 (47.1) | 148 (36.0) |
| C | 2 (50.0) | 6 (35.3) | 178 (43.3) |
| B-symptoms present, n (%) | 1 (25.0) | 9 (52.9) | 205 (49.9) |
| Total CIRS score | |||
| Median (range) | 4 (1-12) | 9 (4-16) | 8 (0-28) |
| >6, n (%) | 2 (50.0) | 16 (94.1) | 345 (83.9) |
| Serum β2-microglobulin (mg/L) | |||
| Median (range) | 4.8 (2.7-8.7) | 3.6 (1.5-7.7) | 4.1 (1.0-14.2) |
| >3.5, n (%) | 3 (75.0) | 9 (52.9) | 236/388 (60.8) |
| Estimated creatinine clearance (mL/min) | |||
| Median (range) | 57.7 (34.0-69.2) | 65.0 (35.6-152.6) | 66.6 (25.1-295.6) |
| <70, n (%) | 4 (100.0) | 10 (58.8) | 234/407 (57.5) |
| Cytogenetic subgroups as per hierarchy,∗ n (%) | |||
| Deletion in 17p | 0 (0.0) | 0 (0.0) | 31/418 (7.4) |
| Deletion in 11q | 1 (25.0) | 1 (5.9) | 74/418 (17.7) |
| Trisomy in 12 | 0 (0.0) | 1 (5.9) | 76/418 (18.2) |
| No abnormalities | 1 (25.0) | 3 (17.6) | 92/418 (22.0) |
| Deletion in 13q∗ alone | 2 (50.0) | 12 (70.6) | 145/418 (34.7) |
| IGHV mutational status,∗ n (%) | |||
| Mutated | 2 (50.0) | 15 (88.2) | 142/387 (36.7) |
| Unmutated | 2 (50.0) | 2 (11.8) | 240/387 (62.0) |
| Nonevaluable | 0 (0.0) | 0 (0.0) | 5/387 (1.3) |
| TP53 mutational status, n (%) | |||
| Mutated | 1 (25.0) | 2 (11.8) | 39/400 (9.8) |
| Unmutated | 3 (75.0) | 15 (88.2) | 361/400 (90.3) |
| TP53 deleted and/or mutated, n (%) | 1 (25.0) | 2 (11.8) | 46/396 (11.6) |
| CLL-IPI risk group, n (%) | |||
| Low | 1 (25.0) | 4 (23.5) | 30/360 (8.3) |
| Intermediate | 1 (25.0) | 4 (23.5) | 90/360 (25.0) |
| High | 1 (25.0) | 7 (41.2) | 202/360 (56.1) |
| Very high | 1 (25.0) | 2 (11.8) | 38/360 (10.6) |
| Complex karyotype group, n (%) | |||
| NCKT | 4 (100.0) | 14/15 (93.3) | 315/378 (83.3) |
| CKT/HCKT | 0 (0.0) | 1/15 (6.7) | 63/378 (16.7) |
CIRS, cumulative illness rating scale; CKT, complex karyotype; CLL-IPI, chronic lymphocytic leukemia international prognostic index; HCKT, highly complex karyotype; ITT, intention-to-treat; NCKT, noncomplex karyotype.
Statistically significant difference in all patients being uMRD at FU60 (pooled cohort of Ven-Obi and Clb-Obi) as compared to the remaining study population.