Baseline characteristics at inclusion
| Characteristic . | Arm A n = 24 . | Arm B n = 48 . | Nonrandomized n = 116 . | Total N = 188 . |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Female | 5 (21) | 15 (31) | 34 (29) | 54 (29) |
| Age, y | ||||
| Median (range) | 66 (48-81) | 71 (45-87) | 68 (36-84) | 68 (36-87) |
| WHO performance, n (%) | ||||
| 0 | 18 (75) | 28 (58) | 76 (62) | 122 (65) |
| 1 | 5 (21) | 20 (42) | 34 (33) | 59 (31) |
| 2 | 1 (4) | 0 (0) | 6 (4) | 7 (4) |
| 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Binet classification, n (%) | ||||
| A | 3 (13) | 4 (8) | 18 (16) | 25 (13) |
| B | 11 (46) | 21 (44) | 47 (41) | 79 (42) |
| C | 9 (38) | 22 (46) | 51 (44) | 82 (44) |
| Creatinine clearance, mL/min | ||||
| Median (range) | 73 (41-125) | 71 (38-127) | 72 (41-123) | 72 (38-127) |
| Baseline tumor lysis syndrome risk, n (%) | ||||
| Low | 5 (21) | 9 (19) | 22 (19) | 36 (19) |
| Medium | 9 (38) | 22 (46) | 52 (45) | 83 (44) |
| High | 10 (42) | 16 (33) | 41 (35) | 67 (36) |
| CIRS score | ||||
| Median (range) | 2 (0-7) | 2 (0-12) | 2 (0-10) | 2 (0-12) |
| >6 | 2 (8) | 1 (2) | 8 (7) | 11 (6) |
| White blood cells, ×109/L | ||||
| Median (range) | 35 (4-425) | 49 (4-391) | 60 (4-408) | 58 (4-425) |
| Platelets, ×109/L | ||||
| Median (range) | 136 (43-277) | 116 (44-374) | 113 (17-363) | 115 (17-374) |
| Hemoglobin, g/dL | ||||
| Median (range) | 12.6 (8.1-16) | 12.2 (8.5-16) | 11.9 (7.1-16.3) | 12.1 (7.1-16.3) |
| β2-microglobulin, mg/L | ||||
| Median (range) | 3.8 (1.7-8.5) | 5.3 (2.0-18.2) | 4.7 (0.8-63.0) | 4.7 (0.8-63) |
| TP53 mutation, n (%) | ||||
| Present | 6 (25) | 8 (17) | 29 (25) | 43 (23) |
| 11q deletion, n (%) | ||||
| Present | 6 (25) | 18 (38) | 34 (29) | 58 (31) |
| 17p13 deletion, n (%) | ||||
| Present | 3 (13) | 5 (10) | 18 (16) | 26 (14) |
| 13q14 deletion, n (%) | ||||
| Present | 13 (54) | 24 (50) | 76 (66) | 113 (60) |
| Trisomy 12, n (%) | ||||
| Present | 4 (17) | 5 (10) | 10 (9) | 19 (10) |
| TP53 pathway aberration (17p deletion and/or TP53 mutation), n (%) | ||||
| Present | 6 (25) | 9 (19) | 30 (26) | 45 (24) |
| GC, n (%) | ||||
| Absence (<3) | 15 (62) | 32 (67) | 89 (77) | 136 (72) |
| Low (3-4) | 5 (21) | 12 (25) | 18 (16) | 35 (19) |
| High (≥5) | 3 (12) | 4 (8) | 9 (8) | 16 (9) |
| IGHV mutational status, n (%) | ||||
| Unmutated | 14 (58) | 32 (67) | 71 (61) | 117 (62) |
| Previous CLL treatment, n (%) | ||||
| 1 | 16 (67) | 30 (63) | 78 (68) | 124 (66) |
| 2 | 6 (25) | 9 (19) | 17 (15) | 32 (17) |
| 3 | 2 (8) | 7 (15) | 15 (13) | 24 (13) |
| ≥4 | 0 (0) | 2 (4) | 5 (5) | 7 (6) |
| Time since last treatment, mo | ||||
| Median (range) | 41 (2-113) | 32 (2-85) | 32 (0-205) | 34 (0-205) |
| FISH results | ||||
| Normal | 7 (29) | 12 (25) | 21 (18) | 40 (21) |
| CLL IPI score, n (%) | ||||
| Low risk | 1 (4) | 0 (0) | 5 (4) | 6 (3) |
| Intermediate risk | 6 (25) | 5 (10) | 16 (14) | 27 (14) |
| High risk | 8 (33) | 29 (60) | 53 (46) | 90 (48) |
| Very high risk | 5 (21) | 8 (17) | 27 (23) | 40 (21) |
| Characteristic . | Arm A n = 24 . | Arm B n = 48 . | Nonrandomized n = 116 . | Total N = 188 . |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Female | 5 (21) | 15 (31) | 34 (29) | 54 (29) |
| Age, y | ||||
| Median (range) | 66 (48-81) | 71 (45-87) | 68 (36-84) | 68 (36-87) |
| WHO performance, n (%) | ||||
| 0 | 18 (75) | 28 (58) | 76 (62) | 122 (65) |
| 1 | 5 (21) | 20 (42) | 34 (33) | 59 (31) |
| 2 | 1 (4) | 0 (0) | 6 (4) | 7 (4) |
| 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Binet classification, n (%) | ||||
| A | 3 (13) | 4 (8) | 18 (16) | 25 (13) |
| B | 11 (46) | 21 (44) | 47 (41) | 79 (42) |
| C | 9 (38) | 22 (46) | 51 (44) | 82 (44) |
| Creatinine clearance, mL/min | ||||
| Median (range) | 73 (41-125) | 71 (38-127) | 72 (41-123) | 72 (38-127) |
| Baseline tumor lysis syndrome risk, n (%) | ||||
| Low | 5 (21) | 9 (19) | 22 (19) | 36 (19) |
| Medium | 9 (38) | 22 (46) | 52 (45) | 83 (44) |
| High | 10 (42) | 16 (33) | 41 (35) | 67 (36) |
| CIRS score | ||||
| Median (range) | 2 (0-7) | 2 (0-12) | 2 (0-10) | 2 (0-12) |
| >6 | 2 (8) | 1 (2) | 8 (7) | 11 (6) |
| White blood cells, ×109/L | ||||
| Median (range) | 35 (4-425) | 49 (4-391) | 60 (4-408) | 58 (4-425) |
| Platelets, ×109/L | ||||
| Median (range) | 136 (43-277) | 116 (44-374) | 113 (17-363) | 115 (17-374) |
| Hemoglobin, g/dL | ||||
| Median (range) | 12.6 (8.1-16) | 12.2 (8.5-16) | 11.9 (7.1-16.3) | 12.1 (7.1-16.3) |
| β2-microglobulin, mg/L | ||||
| Median (range) | 3.8 (1.7-8.5) | 5.3 (2.0-18.2) | 4.7 (0.8-63.0) | 4.7 (0.8-63) |
| TP53 mutation, n (%) | ||||
| Present | 6 (25) | 8 (17) | 29 (25) | 43 (23) |
| 11q deletion, n (%) | ||||
| Present | 6 (25) | 18 (38) | 34 (29) | 58 (31) |
| 17p13 deletion, n (%) | ||||
| Present | 3 (13) | 5 (10) | 18 (16) | 26 (14) |
| 13q14 deletion, n (%) | ||||
| Present | 13 (54) | 24 (50) | 76 (66) | 113 (60) |
| Trisomy 12, n (%) | ||||
| Present | 4 (17) | 5 (10) | 10 (9) | 19 (10) |
| TP53 pathway aberration (17p deletion and/or TP53 mutation), n (%) | ||||
| Present | 6 (25) | 9 (19) | 30 (26) | 45 (24) |
| GC, n (%) | ||||
| Absence (<3) | 15 (62) | 32 (67) | 89 (77) | 136 (72) |
| Low (3-4) | 5 (21) | 12 (25) | 18 (16) | 35 (19) |
| High (≥5) | 3 (12) | 4 (8) | 9 (8) | 16 (9) |
| IGHV mutational status, n (%) | ||||
| Unmutated | 14 (58) | 32 (67) | 71 (61) | 117 (62) |
| Previous CLL treatment, n (%) | ||||
| 1 | 16 (67) | 30 (63) | 78 (68) | 124 (66) |
| 2 | 6 (25) | 9 (19) | 17 (15) | 32 (17) |
| 3 | 2 (8) | 7 (15) | 15 (13) | 24 (13) |
| ≥4 | 0 (0) | 2 (4) | 5 (5) | 7 (6) |
| Time since last treatment, mo | ||||
| Median (range) | 41 (2-113) | 32 (2-85) | 32 (0-205) | 34 (0-205) |
| FISH results | ||||
| Normal | 7 (29) | 12 (25) | 21 (18) | 40 (21) |
| CLL IPI score, n (%) | ||||
| Low risk | 1 (4) | 0 (0) | 5 (4) | 6 (3) |
| Intermediate risk | 6 (25) | 5 (10) | 16 (14) | 27 (14) |
| High risk | 8 (33) | 29 (60) | 53 (46) | 90 (48) |
| Very high risk | 5 (21) | 8 (17) | 27 (23) | 40 (21) |
Baseline characteristics for all included patients (total) and by treatment arm. Data are presented as n (%) unless otherwise indicated.
CIRS, cumulative illness rating scale; del, deletion; FISH, fluorescence in situ hybridization; GC, genome complexity; IPI, International Prognostic Index; TLS, tumor lysis syndrome; WHO, World Health Organization.