Table 1.

Baseline characteristics (N = 38)

CharacteristicValue
Median age, y (range) 64 (47-81) 
Male:female 25:13 
Rai stage at screening  
I-II 21 
III-IV 
Missing 
IGHV, n/N (%)  
Unmutated 27/34 (79) 
Mutated 7/34 (21) 
FISH (according to Döhner hierarchical model), n/N (%)  
del(17p) 7/33 (21) 
del(11q) 9/32 (28) 
Trisomy 12 0/33 (0) 
Normal 8/32 (25) 
del(13q) 9/33 (27) 
TP53 mutation, n/N (%) 9/31 (29) 
Median no. of prior therapies (range) 1 (1-7) 
Type of prior therapies, n/N (%)  
Fludarabine, cyclophosphamide ± rituximab 23/38 (60.5) 
Bendamustine + rituximab 17/38 (45) 
Chlorambucil ± anti-CD20 monoclonal antibody 7/38 8 (18) 
Phosphatidylinositol 3-kinase inhibitor (idelalisib, duvelisib) 5/38 (13) 
TLS risk, n/N (%)  
Low 6/38 (16) 
Medium 18/38 (47) 
High 14/38 (37) 
Median ALC count (×109/L) at screening (range) 97.6 (3.5-208.4) 
ALC ≥ 25 × 109/L at screening, n/N (%) 26/38 (68) 
Lymph node size at screening  
≥5 cm 16 
≥10 cm 
CharacteristicValue
Median age, y (range) 64 (47-81) 
Male:female 25:13 
Rai stage at screening  
I-II 21 
III-IV 
Missing 
IGHV, n/N (%)  
Unmutated 27/34 (79) 
Mutated 7/34 (21) 
FISH (according to Döhner hierarchical model), n/N (%)  
del(17p) 7/33 (21) 
del(11q) 9/32 (28) 
Trisomy 12 0/33 (0) 
Normal 8/32 (25) 
del(13q) 9/33 (27) 
TP53 mutation, n/N (%) 9/31 (29) 
Median no. of prior therapies (range) 1 (1-7) 
Type of prior therapies, n/N (%)  
Fludarabine, cyclophosphamide ± rituximab 23/38 (60.5) 
Bendamustine + rituximab 17/38 (45) 
Chlorambucil ± anti-CD20 monoclonal antibody 7/38 8 (18) 
Phosphatidylinositol 3-kinase inhibitor (idelalisib, duvelisib) 5/38 (13) 
TLS risk, n/N (%)  
Low 6/38 (16) 
Medium 18/38 (47) 
High 14/38 (37) 
Median ALC count (×109/L) at screening (range) 97.6 (3.5-208.4) 
ALC ≥ 25 × 109/L at screening, n/N (%) 26/38 (68) 
Lymph node size at screening  
≥5 cm 16 
≥10 cm 

FISH, fluorescence in situ hybridization.

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