Table 1 Baseline patient characteristics
From: Tislelizumab plus zanubrutinib for Richter transformation: the phase 2 RT1 trial
Patient characteristics | |
|---|---|
All patients | 48 |
Age (years) | 48 |
Median | 67 |
IQR | 60–74 |
Range | 45–82 |
Sex, n (%) | 48 |
Female | 19 (39.6) |
Male | 29 (60.4) |
Time between CLL diagnosis and study registration (months) | 48 |
Median | 79 |
IQR | 49–136 |
Time between RT diagnosis and study registration (months) | 48 |
Median | 0.7 |
IQR | 0.43–1.04 |
Number of previous CLL-directed therapies | 36 |
Median | 3 |
Range | 1–6 |
Patients with previous CLL-directed therapies, n (%) | 36 |
Chemo(immuno)therapy | 25 (69.4) |
SCT | 3 (8.3) |
BTK/BCL-2 inhibitors | 32 (88.9) |
BTK inhibitor | 24 (66.7) |
BCL-2 inhibitor | 22 (61.1) |
BTK + BCL-2 inhibitor | 2 (5.6) |
Other | 9 (25.0) |
Binet stage, n (%) | 48 |
A | 22 (45.8) |
B | 8 (16.7) |
C | 18 (37.5) |
Severe constitutional symptoms, n (%) | 48 |
No | 28 (58.3) |
Yes | 20 (41.7) |
ECOG performance status, n (%) | 48 |
0 | 26 (54.2) |
1 | 15 (31.3) |
2 | 6 (12.5) |
3 | 1 (2.1) |
CIRS total score | 48 |
Median | 4 |
IQR | 2–7 |
CIRS total score, n (%) | 48 |
≤6 | 34 (70.8) |
>6 | 14 (29.2) |
LDH (U l−1) | 48 |
Median | 335 |
IQR | 209–584 |
Patients with LDH > 250 U l−1, n (%) | 31 (64.6) |
Cytogenetic subgroups hierarchical order (according to Döhner et al.46), n (%) | 46 |
Deletion 17p | 10 (21.7) |
Deletion 11q | 4 (8.7) |
Trisomy 12 | 5 (10.9) |
No abnormalities | 19 (41.3) |
Deletion 13q | 8 (17.4) |
Missing | 2 (4.2) |
TP53 mutation status, n (%) | 45 |
Unmutated | 32 (71.1) |
Mutated | 13 (28.9) |
Missing | 3 (6.3) |
TP53 status, n (%) | 46 |
None | 30 (65.2) |
Deleted and/or mutated | 16 (34.8) |
Missing | 2 (4.2) |
IGHV mutation status, n (%) | 41 |
Unmutated | 29 (70.7) |
Mutated | 12 (29.3) |
Missing | 7 (14.6) |
Serum thymidine kinase (U l−1) | 47 |
Median | 40.1 |
IQR | 18.5–108.3 |
Serum β2-microglobulin (mg l−1) | 47 |
Median | 3.8 |
IQR | 2.5–5.5 |
Complex karyotype, n (%) | 38 |
<3 aberrations | 22 (57.9) |
≥3 aberrations | 16 (42.1) |
Missing | 10 (20.8) |
CLL-IPI risk group, n (%) | 39 |
Low | 3 (7.7) |
Intermediate | 11 (28.2) |
High | 10 (25.6) |
Very high | 15 (38.5) |
Missing | 9 (18.8) |
RT features, n (%) | 48 |
Previously untreated RT | 38 (79.2) |
Previously treated with RT-directed therapy | 10 (20.8) |
HL | 2 (4.2) |
DLBCL | 46 (95.8) |
Non-GCB | 14 (29.2) |
GCB | 1 (2.1) |
Unknown | 33 (68.8) |
Clonally unrelated | 0 (0.0) |
Clonally related | 26 (54.2) |
Unknown | 22 (45.8) |
Ki-67 (%) | 31 |
Median | 70 |
IQR | 50–80 |