Baseline characteristics (safety-evaluable population)
| Parameter . | CAVALLI phase 2 (N = 206) . | GOYA IPI 2 to 5 (N = 564) . |
|---|---|---|
| Age, median (range), y | 65 (18-85) | 62 (18-83) |
| Female | 93 (45) | 267 (47) |
| ECOG PS* | ||
| 0-1 | 172 (84) | 476 (84) |
| 2 | 34 (17) | 87 (15) |
| Stage III-IV | 177 (86) | 478 (85) |
| IPI | ||
| 2-3 | 155 (75) | 455 (81) |
| 4-5 | 51 (25) | 109 (19) |
| COO | n = 171 | n = 373 |
| ABC | 48 (28) | 104 (28) |
| GCB | 101 (59) | 213 (57) |
| Unclassified | 22 (13) | 56 (15) |
| Bcl-2 IHC | n = 179 | n = 308 |
| High† | 104 (58) | 151 (49) |
| Low | 75 (42) | 157 (51) |
| Myc IHC | n = 179 | n = 304 |
| Positive | 133 (74) | 248 (82) |
| Negative | 46 (26) | 56 (18) |
| Double expressor | n = 179 | n = 299 |
| Yes | 80 (45) | 124 (41) |
| No | 99 (55) | 175 (59) |
| Bcl-2†and Myc IHC | n = 179 | n = 299 |
| Bcl-2 IHC+/Myc IHC+ (DHL, DEL) | 80 (45) | 124 (41) |
| Bcl-2 IHC+/Myc IHC− | 24 (13) | 24 (8) |
| Bcl-2 IHC−/Myc IHC+ | 53 (30) | 119 (40) |
| BCL-2 FISH | n = 151 | n = 265 |
| Positive | 40 (26) | 59 (22) |
| Negative | 89 (59) | 145 (55) |
| Undetermined | 22 (15) | 61 (23) |
| MYC FISH | n = 142 | n = 232 |
| Positive | 12 (8) | 20 (9) |
| Negative | 110 (78) | 178 (77) |
| Undetermined | 20 (14) | 34 (15) |
| BCL-2 & MYC FISH | n = 139 | n = 230 |
| BCL-2 FISH+/MYC FISH+ (DHL) | 7 (5) | 8 (3) |
| Parameter . | CAVALLI phase 2 (N = 206) . | GOYA IPI 2 to 5 (N = 564) . |
|---|---|---|
| Age, median (range), y | 65 (18-85) | 62 (18-83) |
| Female | 93 (45) | 267 (47) |
| ECOG PS* | ||
| 0-1 | 172 (84) | 476 (84) |
| 2 | 34 (17) | 87 (15) |
| Stage III-IV | 177 (86) | 478 (85) |
| IPI | ||
| 2-3 | 155 (75) | 455 (81) |
| 4-5 | 51 (25) | 109 (19) |
| COO | n = 171 | n = 373 |
| ABC | 48 (28) | 104 (28) |
| GCB | 101 (59) | 213 (57) |
| Unclassified | 22 (13) | 56 (15) |
| Bcl-2 IHC | n = 179 | n = 308 |
| High† | 104 (58) | 151 (49) |
| Low | 75 (42) | 157 (51) |
| Myc IHC | n = 179 | n = 304 |
| Positive | 133 (74) | 248 (82) |
| Negative | 46 (26) | 56 (18) |
| Double expressor | n = 179 | n = 299 |
| Yes | 80 (45) | 124 (41) |
| No | 99 (55) | 175 (59) |
| Bcl-2†and Myc IHC | n = 179 | n = 299 |
| Bcl-2 IHC+/Myc IHC+ (DHL, DEL) | 80 (45) | 124 (41) |
| Bcl-2 IHC+/Myc IHC− | 24 (13) | 24 (8) |
| Bcl-2 IHC−/Myc IHC+ | 53 (30) | 119 (40) |
| BCL-2 FISH | n = 151 | n = 265 |
| Positive | 40 (26) | 59 (22) |
| Negative | 89 (59) | 145 (55) |
| Undetermined | 22 (15) | 61 (23) |
| MYC FISH | n = 142 | n = 232 |
| Positive | 12 (8) | 20 (9) |
| Negative | 110 (78) | 178 (77) |
| Undetermined | 20 (14) | 34 (15) |
| BCL-2 & MYC FISH | n = 139 | n = 230 |
| BCL-2 FISH+/MYC FISH+ (DHL) | 7 (5) | 8 (3) |