Baseline demographics and disease characteristics
| Characteristic . | Ibrutinib + CIT (n = 202) . | Placebo + CIT (n = 201) . |
|---|---|---|
| Median age, y (range) | 59.5 (22-87) | 59 (30-86) |
| ≥65 | 74 (36.6) | 72 (35.8) |
| <65 | 128 (63.4) | 129 (64.2) |
| Sex, n (%) | ||
| Male | 113 (55.9) | 99 (49.3) |
| Female | 89 (44.1) | 102 (50.7) |
| ECOG PS, n (%) | ||
| 0 | 132 (65.3) | 125 (62.2) |
| 1 or 2 | 70 (34.7) | 76 (37.8) |
| FL, n (%) | 174 (86.1) | 173 (86.1) |
| Grade 1 or 2 | 146 (72.3) | 142 (70.6) |
| Grade 3a | 28 (13.9) | 31 (15.4) |
| MZL, n (%) | 28 (13.9) | 28 (13.9) |
| Splenic | 1 (0.5) | 4 (2.0) |
| Nodal | 10 (5.0) | 18 (9.0) |
| Extranodal | 17 (8.4) | 6 (3.0) |
| Gastric | 5 (2.5) | 2 (1.0) |
| Median time since diagnosis, mo (range) | 45.8 (3.2-270.0) | 42.9 (5.1-313.0) |
| Prior LOT, n (%) | ||
| 1 | 108 (53.5) | 112 (55.7) |
| >1 | 94 (46.5) | 89 (44.3) |
| Median time from end of prior LOT to randomization, mo (range) | 23.5 (0.8-124.5) | 20.2 (0.5-114.1) |
| Disease type, n (%) | ||
| Refractory | 49 (24.3) | 43 (21.4) |
| Relapsed | 153 (75.7) | 158 (78.6) |
| Extranodal | 121 (59.9) | 117 (58.2) |
| Bone marrow involvement | 78 (38.6) | 77 (38.3) |
| PRIMA PI, n (%) | ||
| High risk | 54 (26.9) | 46 (23.2) |
| Medium risk | 43 (21.4) | 41 (20.7) |
| Low risk | 104 (51.7) | 111 (56.1) |
| POD24, n (%) | ||
| ≤24 mo | 101 (50.2) | 118 (58.7) |
| >24 mo | 100 (49.8) | 83 (41.3) |
| Backbone CIT (BR/R-CHOP) received during study, n (%) | ||
| BR | 182 (90.1) | 182 (90.5) |
| R-CHOP | 20 (9.9) | 19 (9.5) |
| Characteristic . | Ibrutinib + CIT (n = 202) . | Placebo + CIT (n = 201) . |
|---|---|---|
| Median age, y (range) | 59.5 (22-87) | 59 (30-86) |
| ≥65 | 74 (36.6) | 72 (35.8) |
| <65 | 128 (63.4) | 129 (64.2) |
| Sex, n (%) | ||
| Male | 113 (55.9) | 99 (49.3) |
| Female | 89 (44.1) | 102 (50.7) |
| ECOG PS, n (%) | ||
| 0 | 132 (65.3) | 125 (62.2) |
| 1 or 2 | 70 (34.7) | 76 (37.8) |
| FL, n (%) | 174 (86.1) | 173 (86.1) |
| Grade 1 or 2 | 146 (72.3) | 142 (70.6) |
| Grade 3a | 28 (13.9) | 31 (15.4) |
| MZL, n (%) | 28 (13.9) | 28 (13.9) |
| Splenic | 1 (0.5) | 4 (2.0) |
| Nodal | 10 (5.0) | 18 (9.0) |
| Extranodal | 17 (8.4) | 6 (3.0) |
| Gastric | 5 (2.5) | 2 (1.0) |
| Median time since diagnosis, mo (range) | 45.8 (3.2-270.0) | 42.9 (5.1-313.0) |
| Prior LOT, n (%) | ||
| 1 | 108 (53.5) | 112 (55.7) |
| >1 | 94 (46.5) | 89 (44.3) |
| Median time from end of prior LOT to randomization, mo (range) | 23.5 (0.8-124.5) | 20.2 (0.5-114.1) |
| Disease type, n (%) | ||
| Refractory | 49 (24.3) | 43 (21.4) |
| Relapsed | 153 (75.7) | 158 (78.6) |
| Extranodal | 121 (59.9) | 117 (58.2) |
| Bone marrow involvement | 78 (38.6) | 77 (38.3) |
| PRIMA PI, n (%) | ||
| High risk | 54 (26.9) | 46 (23.2) |
| Medium risk | 43 (21.4) | 41 (20.7) |
| Low risk | 104 (51.7) | 111 (56.1) |
| POD24, n (%) | ||
| ≤24 mo | 101 (50.2) | 118 (58.7) |
| >24 mo | 100 (49.8) | 83 (41.3) |
| Backbone CIT (BR/R-CHOP) received during study, n (%) | ||
| BR | 182 (90.1) | 182 (90.5) |
| R-CHOP | 20 (9.9) | 19 (9.5) |
ECOG PS, Eastern Cooperative Oncology Group performance status; LOT, line of therapy; PRIMA PI, PRIMA prognostic index.