Table 1.

Baseline characteristics at stage 2

Characteristics	ITT population (n = 82)
Sex
Male	51 (62.2%)
Female	31 (37.8%)
Age, years-median (range)	52.5 (32–76)
<60	56 (68.3%)
≥60	26 (31.7%)
ECOG PS
0	43 (52.4%)
1	36 (43.9%)
2	3 (3.7%)
Median time from initial diagnosis to start of study treatment, months (range)	37.7 (4.8-156.2)
Histological grade
Grade 1–2	69 (84.1%)
Grade 3a	13 (15.9%)
Relapsed to last therapies	36 (43.9%)
Refractory to last therapies	46 (56.1%)
Primary refractory	16 (19.5%)
Prior therapy to which the disease was refractory
Rituximab	40 (48.8%)
Rituximab and alkylating agents	26 (31.7%)
FLIPI-2a
0–1	37 (45.7%)
2	23 (28.4%)
3–5	21 (25.9%)
Lugano stage
I–II	9 (11.0%)
III-IV	64 (78.0%)
Other	9 (11.0%)
Bone marrow involvement
Yes	9 (11.0%)
No	71 (86.6%)
Not estimable	2 (2.4%)
Prior radiotherapy
Yes	12 (14.6%)
No	70 (85.4%)
Organ or stem cell transplant (autologous/allogeneic)
No	82 (100.0%)
POD24
Yes	60 (73.2%)
No	22 (26.8%)
Lines of prior systemic therapies, median (range)	3.0 (2.0, 7.0)
2	38 (46.3%)
3	26 (31.7%)
>3	18 (22.0%)
Prior therapies
Rituximab-based regimens	82 (100.0%)
R-CHOP/R-CDOP	76 (92.7%)
Rituximab plus bendamustine	19 (23.2%)
Rituximab plus lenalidomide	1 (1.2%)
Alkylating agents	82 (100.0%)
Immunomodulatory drugs	45 (54.9%)
Bendamustine	26 (31.7%)
BTK inhibitors	13 (15.9%)

Data were presented as the median (range) or n (%)

ITT intent-to-treat, POD24 progression of disease within 24 months, BTK Bruton tyrosine kinase, FLIPI-2 Follicular Lymphoma International Prognostic Index 2, ECOG PS Eastern Cooperative Oncology Group Performance Score

^aTotally 81 patients had FLIPI-2 score because case 49,001 did not complete the initial treatment examination and thus did not evaluate the FLIPI-2