Table 1

Pretreatment patient characteristics

Ofatumumab 500 mg (n = 31)Ofatumumab 1000 mg (n = 30)
Characteristic, median (range)   
    Age, y 56 (38-73) 56 (38-72) 
    β-2M, mg/L 4 (1.8-11.5) 4 (2.1-10.7) 
    Lactate dehydrogenase, IU/L 216 (125-566) 234 (147-1144) 
    Thymidine kinase, IU/L 23 (5-171) 32 (5-201) 
    Lymphocytes, ×109/L 93 (4-302) 77 (8-307) 
    Neutrophils, ×109/L 5 (1.4-13.9) 4.4 (0.9-13.4) 
    Hemoglobin, g/dL 12 (8.0-14.9) 12.3 (6.6-15.8) 
    Platelets, ×109/L 168 (58-351) 135 (50-318) 
Characteristic, no. of patients (%)   
    Rai stage III-IV 12 (39) 16 (53) 
    Binet stage C 8 (26) 12 (40) 
    β-2M > 3.5 mg/L 19 (61) 20 (67) 
    ECOG performance status 1-2 15 (48) 12 (40) 
    Palpable lymph nodes > 5 cm 5 (16) 5 (17) 
    CD38-positive (≥ 30%) 8 (26) 4 (13) 
    Unmutated IGHV* 16 (52) 9 (30) 
    FISH genomic abnormality   
    17p del 2 (6) 6 (20) 
    11q del 7 (23) 3 (10) 
    Trisomy 12 4 (13) 5 (17) 
    No abnormality 5 (16) 2 (7) 
    13q del (sole) 12 (39) 13 (43) 
O-FC courses received, no.   
    6 22 (71) 17 (57) 
    4-5 2 (6) 7 (23) 
    1-3 7 (23) 6 (20) 
Ofatumumab 500 mg (n = 31)Ofatumumab 1000 mg (n = 30)
Characteristic, median (range)   
    Age, y 56 (38-73) 56 (38-72) 
    β-2M, mg/L 4 (1.8-11.5) 4 (2.1-10.7) 
    Lactate dehydrogenase, IU/L 216 (125-566) 234 (147-1144) 
    Thymidine kinase, IU/L 23 (5-171) 32 (5-201) 
    Lymphocytes, ×109/L 93 (4-302) 77 (8-307) 
    Neutrophils, ×109/L 5 (1.4-13.9) 4.4 (0.9-13.4) 
    Hemoglobin, g/dL 12 (8.0-14.9) 12.3 (6.6-15.8) 
    Platelets, ×109/L 168 (58-351) 135 (50-318) 
Characteristic, no. of patients (%)   
    Rai stage III-IV 12 (39) 16 (53) 
    Binet stage C 8 (26) 12 (40) 
    β-2M > 3.5 mg/L 19 (61) 20 (67) 
    ECOG performance status 1-2 15 (48) 12 (40) 
    Palpable lymph nodes > 5 cm 5 (16) 5 (17) 
    CD38-positive (≥ 30%) 8 (26) 4 (13) 
    Unmutated IGHV* 16 (52) 9 (30) 
    FISH genomic abnormality   
    17p del 2 (6) 6 (20) 
    11q del 7 (23) 3 (10) 
    Trisomy 12 4 (13) 5 (17) 
    No abnormality 5 (16) 2 (7) 
    13q del (sole) 12 (39) 13 (43) 
O-FC courses received, no.   
    6 22 (71) 17 (57) 
    4-5 2 (6) 7 (23) 
    1-3 7 (23) 6 (20) 

FISH indicates fluorescence in situ hybridization.

*

Defined as ≥ 98% homology to closest germline sequence.

Based on Dohner hierarchy.24 

Two patients in the 1000-mg cohort received all 6 infusions of ofatumumab but no fludarabine and cyclophosphamide during treatment course 6.

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