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%) |
