Page 231 - 2021_02-Haematologica-web

The CLL2-BIO trial
tions (n=18), infections (n=13), hematologic and gastroin- testinal adverse events (9 each), as well as atrial fibrilla- tion, nervous system and respiratory/thoracic disorders (4 each). Maintenance treatment was started in 59 patients
(91%) and up to the data-cutoff all 59 patients have com- pleted the second cycle.
At the final restaging after induction treatment, all 39 patients being treated first-line (100%) and 21 of the 26
Table 1. Patients’ characteristics. Age, years
median (range)
Time from initial diagnosis, months
median (range)
Sex, n (%) female
male
Binet stage, n (%) A
B
C
Presence of B-symptoms, n (%)
ECOG performance status, n (%) 0
I
II
Treatment-naïve (n=39)
60 (32-80)
25 (4-134)
16 (41%) 23 (59%)
9 (23%) 16 (41%) 14 (36%)
23 (59%)
28 (72%) 11 (28%)
Relapse/refractory (n=26)
68 (41-81)
84 (2-335)
8 (31%) 18 (69%)
7 (27%) 10 (38%) 9 (35%)
10 (38%)
16 (62%)
All patients (n=65)
61 (32-81)
48 (2-335)
24 (37%) 41 (63%)
16 (25%) 26 (40%) 23 (35%)
33 (51%)
44 (68%)
19 (29%)
CIRS score (comorbidity)
median,range 3(0-16) >6,n(%) 6(15%)
3(0-10) 6(23%)
75.3 (31.3-131.5)
9 (35%) 6 (23%) 2 (8%)
6 (23%) 4 (15%) 4 (15%) 5 (19%) 7 (27%)
13 (50%) 3 (12%) 5 (19%)
18 (69%)
4.7 (2.4 – 15.5)
18 (72%)
38.9 (4.0 – 343.5) 23 (92%)
14 (54%)
13 (50%)
1 (4%) 4 (16%) 8 (32%) 12 (48%)
3(0-16) 12(18%)
80.5 (31.3-149.2)
19 (29%) 13 (20%) 4 (6%)
12 (18%) 12 (18%) 10 (15%) 18 (28%) 13 (20%)
20 (31%) 12 (18%) 8 (12%)
45 (69%)
4.2 (2.1 – 15.5)
39 (62%)
36.3 (4.0 – 343.5) 61 (97%)
29 (45%)
29 (45%)
6 (10%) 15 (24%) 25 (40%) 17 (27%)
- 2(8%) 2(3%)
Creatinine-clearance, mL/min median (range)
30-69 mL/min, n (%)
Bulky disease with lymph nodes >5 cm, n (%)
Massive splenomegaly >20 cm, n (%)
Cytogenetics*, n (%) del(17p)
del(11q) trisomy 12 none del(13q)
Molecular genetics, n (%)
TP53 NOTCH1 SF3B1
81.9 (42.9-149.2)
10 (26%) 7 (18%) 2 (5%)
6 (15%) 8 (21%) 6 (15%) 13 (33%) 6 (15%)
7 (18%) 9 (23%) 3 (8%)
27 (69%)
3.7 (2.1 – 11.6)
21 (55%)
(11.5 – 258.0) 38 (100%)
15 (38%)
16 (41%)
5 (13%) 11 (29%) 17 (45%) 5 (13%)
IGHV status, n (%) unmutated
Serum β 2
-microglobulin,** mg/dL median (range)
> 3.5 mg/dL, n (%)
Serum thymidine kinase, U/L** median (range)
> 10 U/L, n (%)
ZAP-70 expression, n (%)
>20%
CD38 expression >30%
CLL-IPI,** n (%) low
intermediate high
very high
29.8
CIRS: Cumulative Illness Rating Scale; ECOG: Eastern Cooperative Oncology Group; IGHV: immunoglobulin heavy-chain variable region; CLL: IPI: chronic lymphocytic leukemia International Prognostic Index; ZAP-70: zeta-chain associated protein kinase 70. *according to the hierarchical model by Döhner et al.; **data for five patients missing.
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