Patient demographics and baseline clinical characteristics
| Characteristic . | Arm A: VEN + R (n = 52) . | Arm B: VEN + BR (n = 51) . | Arm C: BR (n = 51) . |
|---|---|---|---|
| Median age, y (range) | 63 (40-84) | 66 (43-82) | 61 (35-80) |
| Age ≥65 y, n (%) | 23 (44.2) | 29 (56.9) | 22 (43.1) |
| Male, n (%) | 27 (51.9) | 35 (68.6) | 30 (58.8) |
| Lymph node ≥10 cm, n (%) | 5 (9.6) | 4 (7.8) | 7 (13.7) |
| Ann Arbor stage, n (%) | n = 50 | n = 49 | n = 51 |
| I | 2 (4.0) | 5 (10.2) | 4 (7.8) |
| II | 4 (8.0) | 8 (16.3) | 10 (19.6) |
| III | 9 (18.0) | 13 (26.5) | 7 (13.7) |
| IV | 35 (70.0) | 23 (46.9) | 30 (58.8) |
| ECOG performance status, n (%) | n = 52 | n = 48 | n = 50 |
| 0 | 36 (69.2) | 28 (58.3) | 34 (68.0) |
| 1 | 16 (30.8) | 19 (39.6) | 16 (32.0) |
| 2 | 0 | 1 (2.1) | 0 |
| FL grade 3a, n (%) | n = 52 | n = 50 | n = 50 |
| 7 (13.5) | 7 (14.0) | 9 (18.0) | |
| Bone marrow infiltration, n (%) | n = 51 | n = 51 | n = 49 |
| Yes | 18 (35.3) | 19 (37.3) | 13 (26.5) |
| No | 32 (62.7) | 31 (60.8) | 35 (71.4) |
| Unknown | 1 (2.0) | 1 (2.0) | 1 (2.0) |
| Extranodal involvement, n (%) | |||
| Yes | 31 (59.6) | 30 (58.8) | 27 (52.9) |
| No | 21 (40.4) | 21 (41.2) | 24 (47.1) |
| Prior therapies, n | |||
| Minimum to maximum | 1-6 | 1-6 | 1-4 |
| Median | 3 | 3 | 2 |
| Refractory* to last treatment, n (%) | 26 (50.0) | 19 (37.3) | 23 (45.1) |
| Refractory to R, n (%) | 17 (32.7) | 14 (27.5) | 21 (41.2) |
| Duration of prior therapy response, n (%) | n = 49 | n = 51 | n = 50 |
| ≤12 mo | 29 (59.2) | 22 (43.1) | 26 (52.0) |
| >12 mo | 20 (40.8) | 29 (56.9) | 24 (48.0) |
| Disease burden (GELF), n (%) | n = 52 | n = 51 | n = 51 |
| Low | 9 (17.3) | 14 (27.5) | 17 (33.3) |
| High | 43 (82.7) | 37 (72.5) | 34 (66.7) |
| BCL-2 IHC evaluable, n (%) | n = 48 | n = 46 | n = 43 |
| Negative (0-1) | 6 (12.5) | 4 (8.7) | 7 (16.3) |
| Positive (2-3) | 42 (87.5) | 42 (91.3) | 36 (83.7) |
| BCL-2 FISH evaluable, n (%) | n = 40 | n = 33 | n = 33 |
| Negative | 3 (7.5) | 4 (12.1) | 3 (9.1) |
| Positive | 35 (87.5) | 24 (72.7) | 27 (81.8) |
| Undetermined | 2 (5.0) | 5 (15.2) | 3 (9.1) |
| BCL-XL IHC evaluable, n (%) | n = 42 | n = 46 | n = 42 |
| IHC score ≥2,3 | 9 (21) | 15 (33) | 14 (33) |
| MCL-1 IHC evaluable, n (%) | n = 37 | n = 38 | n = 38 |
| IHC score† ≥2 | 0 (0) | 0 (0) | 2 (5) |
| Characteristic . | Arm A: VEN + R (n = 52) . | Arm B: VEN + BR (n = 51) . | Arm C: BR (n = 51) . |
|---|---|---|---|
| Median age, y (range) | 63 (40-84) | 66 (43-82) | 61 (35-80) |
| Age ≥65 y, n (%) | 23 (44.2) | 29 (56.9) | 22 (43.1) |
| Male, n (%) | 27 (51.9) | 35 (68.6) | 30 (58.8) |
| Lymph node ≥10 cm, n (%) | 5 (9.6) | 4 (7.8) | 7 (13.7) |
| Ann Arbor stage, n (%) | n = 50 | n = 49 | n = 51 |
| I | 2 (4.0) | 5 (10.2) | 4 (7.8) |
| II | 4 (8.0) | 8 (16.3) | 10 (19.6) |
| III | 9 (18.0) | 13 (26.5) | 7 (13.7) |
| IV | 35 (70.0) | 23 (46.9) | 30 (58.8) |
| ECOG performance status, n (%) | n = 52 | n = 48 | n = 50 |
| 0 | 36 (69.2) | 28 (58.3) | 34 (68.0) |
| 1 | 16 (30.8) | 19 (39.6) | 16 (32.0) |
| 2 | 0 | 1 (2.1) | 0 |
| FL grade 3a, n (%) | n = 52 | n = 50 | n = 50 |
| 7 (13.5) | 7 (14.0) | 9 (18.0) | |
| Bone marrow infiltration, n (%) | n = 51 | n = 51 | n = 49 |
| Yes | 18 (35.3) | 19 (37.3) | 13 (26.5) |
| No | 32 (62.7) | 31 (60.8) | 35 (71.4) |
| Unknown | 1 (2.0) | 1 (2.0) | 1 (2.0) |
| Extranodal involvement, n (%) | |||
| Yes | 31 (59.6) | 30 (58.8) | 27 (52.9) |
| No | 21 (40.4) | 21 (41.2) | 24 (47.1) |
| Prior therapies, n | |||
| Minimum to maximum | 1-6 | 1-6 | 1-4 |
| Median | 3 | 3 | 2 |
| Refractory* to last treatment, n (%) | 26 (50.0) | 19 (37.3) | 23 (45.1) |
| Refractory to R, n (%) | 17 (32.7) | 14 (27.5) | 21 (41.2) |
| Duration of prior therapy response, n (%) | n = 49 | n = 51 | n = 50 |
| ≤12 mo | 29 (59.2) | 22 (43.1) | 26 (52.0) |
| >12 mo | 20 (40.8) | 29 (56.9) | 24 (48.0) |
| Disease burden (GELF), n (%) | n = 52 | n = 51 | n = 51 |
| Low | 9 (17.3) | 14 (27.5) | 17 (33.3) |
| High | 43 (82.7) | 37 (72.5) | 34 (66.7) |
| BCL-2 IHC evaluable, n (%) | n = 48 | n = 46 | n = 43 |
| Negative (0-1) | 6 (12.5) | 4 (8.7) | 7 (16.3) |
| Positive (2-3) | 42 (87.5) | 42 (91.3) | 36 (83.7) |
| BCL-2 FISH evaluable, n (%) | n = 40 | n = 33 | n = 33 |
| Negative | 3 (7.5) | 4 (12.1) | 3 (9.1) |
| Positive | 35 (87.5) | 24 (72.7) | 27 (81.8) |
| Undetermined | 2 (5.0) | 5 (15.2) | 3 (9.1) |
| BCL-XL IHC evaluable, n (%) | n = 42 | n = 46 | n = 42 |
| IHC score ≥2,3 | 9 (21) | 15 (33) | 14 (33) |
| MCL-1 IHC evaluable, n (%) | n = 37 | n = 38 | n = 38 |
| IHC score† ≥2 | 0 (0) | 0 (0) | 2 (5) |