Table 1. Patient demographics and... | American Society of Hematology

Table 1.

Patient demographics and baseline characteristics

Characteristic	Duvelisib(n = 160)	Ofatumumab(n = 159)
Median age (range), y	69 (39-90)	69 (39-89)
Male, %	60	60
ECOG PS 2, %	7	10
CLL/SLL, %	97/5	99/2
Median time from initial diagnosis, y	7.5	6.7
Rai stage ≥III/Binet stage C, %	56/41	56/34
Bulky disease (≥5 cm target lesion), %	46	45
Enlarged liver*, %	18	18
Enlarged spleen*,%	38	32
Baseline lymphocytes (×10⁹/L), median	38	35
Grade 4 cytopenia†, %	11	11
Refractory/early relapse to purine therapy‡	31	30
Molecular features (per central laboratory), %
17p deletion	21	28
TP53 mutation	20	18
17p deletion and/or TP53 mutation	31	33
Unmutated IGHV	69	73
CD38 positive	43	44
ZAP70 positive (>19%)	54	52

Characteristic	Duvelisib(n = 160)	Ofatumumab(n = 159)
Median age (range), y	69 (39-90)	69 (39-89)
Male, %	60	60
ECOG PS 2, %	7	10
CLL/SLL, %	97/5	99/2
Median time from initial diagnosis, y	7.5	6.7
Rai stage ≥III/Binet stage C, %	56/41	56/34
Bulky disease (≥5 cm target lesion), %	46	45
Enlarged liver*, %	18	18
Enlarged spleen*,%	38	32
Baseline lymphocytes (×10⁹/L), median	38	35
Grade 4 cytopenia†, %	11	11
Refractory/early relapse to purine therapy‡	31	30
Molecular features (per central laboratory), %
17p deletion	21	28
TP53 mutation	20	18
17p deletion and/or TP53 mutation	31	33
Unmutated IGHV	69	73
CD38 positive	43	44
ZAP70 positive (>19%)	54	52

ECOG, Eastern Cooperative Oncology Group; IGHV, immunoglobulin heavy chain variable; PS, performance status.

As assessed by study investigators during screening.

Thrombocytopenia and/or neutropenia.

Progression <12 mo after fludarabine/pentostatin.