Table I.
Summary of baseline demographics and disease characteristics.
| Characteristic |
TN (n = 22) |
R/R (n = 101) |
|---|---|---|
| Demographics | ||
| Age, years, median (range) | 69·5 (48–87) | 66·0 (24–87) |
| ≥75 years, n (%) | 4 (18·2) | 17 (16·8) |
| Male sex, n (%) | 18 (81·8) | 74 (73·3) |
| ECOG performance status, n (%) | ||
| 0 | 9 (40·9) | 48 (47·5) |
| 1 | 11 (50·0) | 50 (49·5) |
| 2 | 2 (9·1) | 3 (3·0) |
| Prior no. of anti‐cancer therapies, median (range) | 0 (0) | 2 (1–10) |
| Disease characteristics | ||
| SLL, n (%) | 2 (9·1) | 3 (3·0) |
| Rai stage for CLL, n (%) | ||
| Low risk (Stage 0) | 2 (9·1) | 9 (8·9) |
| Intermediate risk (Stages I–II) | 10 (45·5) | 31 (30·7) |
| High risk (Stages ≥III) | 7 (31·8) | 42 (41·6) |
| No staging | 1 (4·5) | 16 (15·8) |
| Bulky disease, n (%) | ||
| Any TL LDi ≥5 cm | 7 (31·8) | 40 (39·6) |
| Any TL LDi ≥10 cm | 1 (4·5) | 4 (4·0) |
| Mutational status, n/N (%) | ||
| del(13q) | 8/18 (44·4) | 37/80 (46·3) |
| del(11q) | 0/18 (0) | 23/80 (22·8) |
| del(17p) | 3/18 (16·7) | 13/81 (16·0) |
| Trisomy 12 | 3/18 (16·7) | 12/79 (15·2) |
| TP53 mutated | 3/18 (37·5) | 11/35 (31·4) |
| del(17p) and TP53 mutated | 1/18 (5·6) | 5/83 (6·0) |
| IGHV unmutated | 2/5 (40·0) | 27/37 (73·0) |
| ALC, × 109/l, median | 76·9 | 26·4 |
| Haemoglobin, g/l, median | 122·5 | 124·0 |
| Platelet count, × 109/l, median | 136·0 | 124·0 |
ALC, absolute lymphocyte count; CLL, chronic lymphocytic lymphoma; ECOG, Eastern Cooperative Oncology Group; IGHV, immunoglobulin heavy chain variable; TL, target lesion; LDi, diameter of largest lymph node; R/R, relapsed/refractory; SLL, small lymphocytic leukaemia; TN, treatment‐naïve; TP53, tumour protein p53.