Table 1 Patient characteristics
Overall cohort Full analysis set (n = 39) | Blinatumomab cohort Blinatumomab efficacy/safety set (n = 25) | |
|---|---|---|
Age, years | 67 [38–83] | 66 [38–83] |
Sex, male/female | 26/13 | 16/9 |
Comorbidities | ||
Past history of cancer | 10 (26%) | 4 (16%) |
Median creatinine clearance, mL/min (Cockroft formula) | 78 [34–148] | 78 [34–148] |
CIRS > 6 | 6 (15%) | 4 (16%) |
ECOG performance status | ||
0–1 | 25 (64%) | 16 (64%) |
2 | 14 (36%) | 9 (36%) |
CLL features | ||
Binet stage at diagnosis | ||
A | 21 (54%) | 11 (44%) |
B | 13 (33%) | 11 (44%) |
C | 5 (13%) | 3 (12%) |
Absolute lymphocytes count (G/L) | 2.8 [0.28–453] | 2.24 [0.28–109] |
Genomic features | ||
del(17p) | 19/35 (54%) | 14/25 (56%) |
TP53 mutation | 21/34 (62%) | 13/22 (59%) |
del(11q) | 5/34 (15%) | 3/23 (13%) |
Karyotype Simple (<3 abn) Complex (3 or 4 abn) Highly complex (≥5 abn) | 11/32 (34%) 1/32 (3%) 20/32 (63%) | 8/23 (35%) 1/23 (4%) 14/23 (61%) |
Unmutated IGHV | 23/33 (70%) | 16/23 (70%) |
Prior therapeutic lines for CLL | ||
Number | 2 [0–11] | 1 [0–11] |
None | 5 (13%) | 2 (8%) |
Chemo-immunotherapy | 22 (56%) | 16 (64%) |
Ibrutinib | 24 (62%) | 15 (60%) |
Idelalisib | 4 (10%) | 3 (12%) |
Venetoclax | 13 (33%) | 7 (28%) |
Double exposed to ibrutinib and venetoclax | 11 (28%) | 7 (28%) |
Transplantation (auto-HSCT/allo-HSCT) | 2 (8%) (1/2) | 2 (8%) (1/2) |
Richter transformation features | ||
Time from CLL diagnosis to RT, years | 7 [0–27] | 7 [0–26] |
B symptoms | 16 (41%) | 13 (52%) |
Ann Arbor staging | ||
I–II | 4 (10%) | 3 (12%) |
III–IV | 35 (90%) | 22 (88%) |
IPI | ||
0–1 | 2 (5%) | 2 (8%) |
2–3 | 28 (80%) | 17 (68%) |
4–5 | 9 (23%) | 6 (24%) |
Histology | ||
DLBCL, NOS | 38 (97%) | 24 (96%) |
non-GC | 31 (79%) | 20 (80%) |
GC | 6 (15%) | 4 (16%) |
not determined | 1 (3%) | 0 (0%) |
HGBL, NOS | 1 (3%) | 1 (4%) |
Clonal relationship | ||
Related | 6 (15.4%) | 3 (12%) |
Unrelated | 2 (5.1%) | 2 (8%) |
Unknown | 31 (79.5%) | 20 (80%) |