Key baseline characteristics of patients in the CAPTIVATE MRD cohort with immune restoration data
| Characteristic . | All treated patients N = 79 . | Confirmed uMRD . | uMRD Not Confirmed . | ||
|---|---|---|---|---|---|
| Placebo n = 20 . | Ibrutinib n = 20 . | Ibrutinib n = 20 . | Ibrutinib + venetoclax n = 19 . | ||
| Age, median (range), y | 59 (28-69) | 62 (50-69) | 57.5 (34-69) | 57 (28-69) | 56 (37-69) |
| Male, n (%) | 48 (61) | 13 (65) | 11 (55) | 11 (55) | 13 (68) |
| Rai stage III/IV disease, n (%) | 27 (34) | 10 (50) | 3 (15) | 7 (35) | 7 (37) |
| Bulky disease, n (%) | |||||
| ≥5 cm | 17 (22) | 5 (25) | 3 (15) | 4 (20) | 5 (26) |
| ≥10 cm | 1 (1) | 0 | 1 (5) | 0 | 0 |
| High-risk genomic features, n (%) | |||||
| Unmutated IGHV | 38 (48) | 11 (55) | 12 (60) | 7 (35) | 8 (42) |
| del(17p)/TP53 mutation | 16 (20) | 2 (10) | 6 (30) | 3 (15) | 5 (26) |
| Complex karyotype | 14 (18) | 4 (20) | 5 (25) | 3 (15) | 2 (11) |
| del(11q)∗ | 10 (13) | 3 (15) | 4 (20) | 2 (10) | 1 (5) |
| Any cytopenia, n (%) | 30 (38) | 12 (60) | 3 (15) | 7 (35) | 8 (42) |
| Hemoglobin ≤11 g/dL | 18 (23) | 8 (40) | 1 (5) | 4 (20) | 5 (26) |
| Platelets ≤100 × 109/L | 16 (20) | 3 (15) | 2 (10) | 5 (25) | 6 (32) |
| ANC ≤1.5 × 109/L | 5 (6) | 3 (15) | 0 | 1 (5) | 1 (5) |
| ALC × 109/L, median (range) | 85 (3-419) | 55 (14-235) | 87 (18-256) | 90 (5-342) | 93 (3-419) |
| ALC ≥ 25 × 109/L, n (%) | 69 (87) | 18 (90) | 19 (95) | 17 (85) | 15 (79) |
| Characteristic . | All treated patients N = 79 . | Confirmed uMRD . | uMRD Not Confirmed . | ||
|---|---|---|---|---|---|
| Placebo n = 20 . | Ibrutinib n = 20 . | Ibrutinib n = 20 . | Ibrutinib + venetoclax n = 19 . | ||
| Age, median (range), y | 59 (28-69) | 62 (50-69) | 57.5 (34-69) | 57 (28-69) | 56 (37-69) |
| Male, n (%) | 48 (61) | 13 (65) | 11 (55) | 11 (55) | 13 (68) |
| Rai stage III/IV disease, n (%) | 27 (34) | 10 (50) | 3 (15) | 7 (35) | 7 (37) |
| Bulky disease, n (%) | |||||
| ≥5 cm | 17 (22) | 5 (25) | 3 (15) | 4 (20) | 5 (26) |
| ≥10 cm | 1 (1) | 0 | 1 (5) | 0 | 0 |
| High-risk genomic features, n (%) | |||||
| Unmutated IGHV | 38 (48) | 11 (55) | 12 (60) | 7 (35) | 8 (42) |
| del(17p)/TP53 mutation | 16 (20) | 2 (10) | 6 (30) | 3 (15) | 5 (26) |
| Complex karyotype | 14 (18) | 4 (20) | 5 (25) | 3 (15) | 2 (11) |
| del(11q)∗ | 10 (13) | 3 (15) | 4 (20) | 2 (10) | 1 (5) |
| Any cytopenia, n (%) | 30 (38) | 12 (60) | 3 (15) | 7 (35) | 8 (42) |
| Hemoglobin ≤11 g/dL | 18 (23) | 8 (40) | 1 (5) | 4 (20) | 5 (26) |
| Platelets ≤100 × 109/L | 16 (20) | 3 (15) | 2 (10) | 5 (25) | 6 (32) |
| ANC ≤1.5 × 109/L | 5 (6) | 3 (15) | 0 | 1 (5) | 1 (5) |
| ALC × 109/L, median (range) | 85 (3-419) | 55 (14-235) | 87 (18-256) | 90 (5-342) | 93 (3-419) |
| ALC ≥ 25 × 109/L, n (%) | 69 (87) | 18 (90) | 19 (95) | 17 (85) | 15 (79) |
ANC, absolute neutrophil count; ALC, absolute lymphocyte count; IGHV, unmutated immunoglobulin heavy-chain variable region gene.
Without del(17p) per Döhner hierarchy.