Baseline characteristics in the overall population and patient subgroups
| Characteristic . | Overall N = 476 . | BTKi . | Prior therapies . | Bendamustine . | |||
|---|---|---|---|---|---|---|---|
| Prior, n = 412 . | No prior, n = 57 . | 1-2 lines, n = 104 . | ≥3 lines, n = 365 . | Prior, n = 259 . | No prior, n = 210 . | ||
| Age at infusion, median (range), y | 67.0 (34.1-84.9) | 67.3 (34.1-84.9) | 66.1 (41.9-83.7) | 67.0 (34.3-83.0) | 67.0 (34.1-84.9) | 69.5 (36.6-84.9) | 64.9 (34.1-83.7) |
| ≥65, n (%) | 288 (61) | 249 (60) | 35 (61) | 66 (63) | 218 (60) | 180 (69) | 104 (50) |
| Male, n (%) | 362 (76) | 310 (75) | 47 (82) | 78 (75) | 279 (76) | 192 (74) | 165 (79) |
| Race/ethnicity, n (%) | |||||||
| Non-Hispanic White | 375 (79) | 322 (78) | 47 (82) | 78 (75) | 291 (80) | 213 (82) | 156 (74) |
| Non-Hispanic Black | 18 (4) | 15 (4) | 3 (5) | 3 (3) | 15 (4) | 9 (3) | 9 (4) |
| Hispanic or Latino | 47 (10) | 42 (10) | 5 (9) | 15 (14) | 32 (9) | 20 (8) | 27 (13) |
| Other or unknown | 36 (8) | 33 (8) | 2 (4) | 8 (8) | 27 (7) | 17 (7) | 18 (9) |
| ECOG PS before infusion, n/n (%) | |||||||
| 0-1 | 407/430 (95) | 348/370 (94) | 52/53 (98) | 86/87 (99) | 314/336 (93) | 227/241 (94) | 173/182 (95) |
| ≥2 | 23/430 (5) | 22/370 (6) | 1/53 (2) | 1/87 (1) | 22/336 (7) | 14/241 (6) | 9/182 (5) |
| Not reported, n | 46 | 42 | 4 | 17 | 29 | 18 | 28 |
| Clinically significant comorbidities, n/n (%) | 358/470 (76) | 307/406 (76) | 46/57 (81) | 75/103 (73) | 278/360 (77) | 197/255 (77) | 156/208 (75) |
| Not reported, n | 6 | 6 | 0 | 1 | 5 | 4 | 2 |
| HCT-CI score before infusion, n (%) | |||||||
| 0 | 131 (28) | 117 (28) | 12 (21) | 34 (33) | 95 (26) | 70 (27) | 59 (28) |
| 1 | 108 (23) | 91 (22) | 16 (28) | 23 (22) | 84 (23) | 53 (20) | 54 (26) |
| 2 | 65 (14) | 57 (14) | 7 (12) | 11 (11) | 53 (15) | 36 (14) | 28 (13) |
| ≥3 | 172 (36) | 147 (36) | 22 (39) | 36 (35) | 133 (36) | 100 (39) | 69 (33) |
| CR/PR achieved before lymphodepletion/infusion, n/n (%) | |||||||
| Yes | 125/432 (29) | 109/386 (28) | 14/42 (33) | 30/95 (32) | 93/333 (28) | 65/240 (27) | 58/188 (31) |
| No | 307/432 (71) | 277/386 (72) | 28/42 (67) | 65/95 (68) | 240/333 (72) | 175/240 (73) | 130/188 (69) |
| Not reported, n | 44 | 26 | 15 | 9 | 32 | 19 | 22 |
| More than 1 extranodal sites at initial diagnosis, n/n (%) | 161/419 (38) | 137/359 (38) | 20/54 (37) | 42/90 (47) | 115/323 (36) | 84/232 (36) | 73/181 (40) |
| Not reported, n | 57 | 53 | 3 | 14 | 42 | 27 | 29 |
| Disease stage at diagnosis, n/n (%) | |||||||
| I or II | 36/392 (9) | 30/341 (9) | 5/46 (11) | 4/79 (5) | 31/308 (10) | 23/221 (10) | 12/166 (7) |
| III or IV | 356/392 (91) | 311/341 (91) | 41/46 (89) | 75/79 (95) | 277/308 (90) | 198/221 (90) | 154/166 (93) |
| Not reported, n | 84 | 71 | 11 | 25 | 57 | 38 | 44 |
| Ki-67 proliferation index of ≥30% at diagnosis, n/n (%) | 184/271 (68) | 161/235 (69) | 23/36 (64) | 48/69 (70) | 136/202 (67) | 91/148 (61) | 93/123 (76) |
| Not reported, n | 205 | 177 | 21 | 35 | 163 | 111 | 87 |
| Ki-67 proliferation index of ≥50% at diagnosis, n/n (%) | 117/271 (43) | 108/235 (46) | 9/36 (25) | 31/69 (45) | 86/202 (43) | 54/148 (36) | 63/123 (51) |
| Not reported, n | 205 | 177 | 21 | 35 | 163 | 111 | 87 |
| TP53 or 17p deletion at diagnosis, n/n (%) | 49/253 (19) | 40/212 (19) | 9/37 (24) | 17/56 (30) | 32/193 (17) | 21/131 (16) | 28/118 (24) |
| Not reported, n | 223 | 200 | 20 | 48 | 172 | 128 | 92 |
| Elevated LDH at initial diagnosis, n/n (%) | 126/260 (48) | 105/225 (47) | 18/31 (58) | 30/60 (50) | 93/196 (47) | 63/143 (44) | 60/113 (53) |
| Not reported, n | 216 | 187 | 26 | 44 | 169 | 116 | 97 |
| Active CNS involvement before infusion, n/n (%) | 19/443 (4) | 18/384 (5) | 0/53 (0) | 1/95 (1) | 17/342 (5) | 12/244 (5) | 6/193 (3) |
| Not reported, n | 33 | 28 | 4 | 9 | 23 | 15 | 17 |
| No. of lines of prior therapy before leukapheresis, median (min-max)∗ | 4 (1-12) | 4 (1-12) | 2 (1-7) | 2 (1-2) | 4 (3-12) | 4 (1-12) | 3 (1-10) |
| 1 prior line, n/n (%) | 18/473 (4) | 8/412 (2) | 10/57 (18) | 18/104 (17) | 0/365 (0) | 3/259 (1) | 15/210 (7) |
| 2 prior lines, n/n (%) | 86/473 (18) | 64/412 (16) | 22/57 (39) | 86/104 (83) | 0/365 (0) | 37/259 (14) | 49/210 (23) |
| ≥3 prior lines, n/n (%) | 369/473 (78) | 340/412 (83) | 25/57 (44) | 0/104 (0) | 365/365 (100) | 219/259 (85) | 146/210 (70) |
| Not reported, n | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Prior bendamustine, n or n/n (%) | 261/473 (55) | 236 (57) | 23 (40) | 40 (38) | 219 (60) | 259 (100) | 0 |
| Prior BTKi, n or n/n (%) | 415/472 (88) | 412 (100) | 0 | 72 (69) | 340 (93) | 236 (91) | 176 (84) |
| Prior auto-HCT, n (%) | 143 (30) | 121 (29) | 19 (33) | 22 (21) | 118 (32) | 50 (19) | 90 (43) |
| Bridging therapy (any type), n/n (%)† | 208/460 (45) | 194/402 (48) | 11/54 (20) | 32/101 (32) | 173/355 (49) | 118/252 (47) | 87/204 (43) |
| Not reported, n | 16 | 10 | 3 | 3 | 10 | 7 | 6 |
| Time from leukapheresis to infusion, median (IQR), d | 28.0 (26.0-34.0) | 29.0 (26.0-35.0) | 27.0 (25.0-31.0) | 28.0 (26.0-33.5) | 28.0 (26.0-35.0) | 29.0 (26.0-38.0) | 28.0 (26.0-33.0) |
| Planned infusion in outpatient setting, n (%) | 41 (9) | 36 (9) | 5 (9) | 11 (11) | 30 (8) | 27 (10) | 14 (7) |
| Characteristic . | Overall N = 476 . | BTKi . | Prior therapies . | Bendamustine . | |||
|---|---|---|---|---|---|---|---|
| Prior, n = 412 . | No prior, n = 57 . | 1-2 lines, n = 104 . | ≥3 lines, n = 365 . | Prior, n = 259 . | No prior, n = 210 . | ||
| Age at infusion, median (range), y | 67.0 (34.1-84.9) | 67.3 (34.1-84.9) | 66.1 (41.9-83.7) | 67.0 (34.3-83.0) | 67.0 (34.1-84.9) | 69.5 (36.6-84.9) | 64.9 (34.1-83.7) |
| ≥65, n (%) | 288 (61) | 249 (60) | 35 (61) | 66 (63) | 218 (60) | 180 (69) | 104 (50) |
| Male, n (%) | 362 (76) | 310 (75) | 47 (82) | 78 (75) | 279 (76) | 192 (74) | 165 (79) |
| Race/ethnicity, n (%) | |||||||
| Non-Hispanic White | 375 (79) | 322 (78) | 47 (82) | 78 (75) | 291 (80) | 213 (82) | 156 (74) |
| Non-Hispanic Black | 18 (4) | 15 (4) | 3 (5) | 3 (3) | 15 (4) | 9 (3) | 9 (4) |
| Hispanic or Latino | 47 (10) | 42 (10) | 5 (9) | 15 (14) | 32 (9) | 20 (8) | 27 (13) |
| Other or unknown | 36 (8) | 33 (8) | 2 (4) | 8 (8) | 27 (7) | 17 (7) | 18 (9) |
| ECOG PS before infusion, n/n (%) | |||||||
| 0-1 | 407/430 (95) | 348/370 (94) | 52/53 (98) | 86/87 (99) | 314/336 (93) | 227/241 (94) | 173/182 (95) |
| ≥2 | 23/430 (5) | 22/370 (6) | 1/53 (2) | 1/87 (1) | 22/336 (7) | 14/241 (6) | 9/182 (5) |
| Not reported, n | 46 | 42 | 4 | 17 | 29 | 18 | 28 |
| Clinically significant comorbidities, n/n (%) | 358/470 (76) | 307/406 (76) | 46/57 (81) | 75/103 (73) | 278/360 (77) | 197/255 (77) | 156/208 (75) |
| Not reported, n | 6 | 6 | 0 | 1 | 5 | 4 | 2 |
| HCT-CI score before infusion, n (%) | |||||||
| 0 | 131 (28) | 117 (28) | 12 (21) | 34 (33) | 95 (26) | 70 (27) | 59 (28) |
| 1 | 108 (23) | 91 (22) | 16 (28) | 23 (22) | 84 (23) | 53 (20) | 54 (26) |
| 2 | 65 (14) | 57 (14) | 7 (12) | 11 (11) | 53 (15) | 36 (14) | 28 (13) |
| ≥3 | 172 (36) | 147 (36) | 22 (39) | 36 (35) | 133 (36) | 100 (39) | 69 (33) |
| CR/PR achieved before lymphodepletion/infusion, n/n (%) | |||||||
| Yes | 125/432 (29) | 109/386 (28) | 14/42 (33) | 30/95 (32) | 93/333 (28) | 65/240 (27) | 58/188 (31) |
| No | 307/432 (71) | 277/386 (72) | 28/42 (67) | 65/95 (68) | 240/333 (72) | 175/240 (73) | 130/188 (69) |
| Not reported, n | 44 | 26 | 15 | 9 | 32 | 19 | 22 |
| More than 1 extranodal sites at initial diagnosis, n/n (%) | 161/419 (38) | 137/359 (38) | 20/54 (37) | 42/90 (47) | 115/323 (36) | 84/232 (36) | 73/181 (40) |
| Not reported, n | 57 | 53 | 3 | 14 | 42 | 27 | 29 |
| Disease stage at diagnosis, n/n (%) | |||||||
| I or II | 36/392 (9) | 30/341 (9) | 5/46 (11) | 4/79 (5) | 31/308 (10) | 23/221 (10) | 12/166 (7) |
| III or IV | 356/392 (91) | 311/341 (91) | 41/46 (89) | 75/79 (95) | 277/308 (90) | 198/221 (90) | 154/166 (93) |
| Not reported, n | 84 | 71 | 11 | 25 | 57 | 38 | 44 |
| Ki-67 proliferation index of ≥30% at diagnosis, n/n (%) | 184/271 (68) | 161/235 (69) | 23/36 (64) | 48/69 (70) | 136/202 (67) | 91/148 (61) | 93/123 (76) |
| Not reported, n | 205 | 177 | 21 | 35 | 163 | 111 | 87 |
| Ki-67 proliferation index of ≥50% at diagnosis, n/n (%) | 117/271 (43) | 108/235 (46) | 9/36 (25) | 31/69 (45) | 86/202 (43) | 54/148 (36) | 63/123 (51) |
| Not reported, n | 205 | 177 | 21 | 35 | 163 | 111 | 87 |
| TP53 or 17p deletion at diagnosis, n/n (%) | 49/253 (19) | 40/212 (19) | 9/37 (24) | 17/56 (30) | 32/193 (17) | 21/131 (16) | 28/118 (24) |
| Not reported, n | 223 | 200 | 20 | 48 | 172 | 128 | 92 |
| Elevated LDH at initial diagnosis, n/n (%) | 126/260 (48) | 105/225 (47) | 18/31 (58) | 30/60 (50) | 93/196 (47) | 63/143 (44) | 60/113 (53) |
| Not reported, n | 216 | 187 | 26 | 44 | 169 | 116 | 97 |
| Active CNS involvement before infusion, n/n (%) | 19/443 (4) | 18/384 (5) | 0/53 (0) | 1/95 (1) | 17/342 (5) | 12/244 (5) | 6/193 (3) |
| Not reported, n | 33 | 28 | 4 | 9 | 23 | 15 | 17 |
| No. of lines of prior therapy before leukapheresis, median (min-max)∗ | 4 (1-12) | 4 (1-12) | 2 (1-7) | 2 (1-2) | 4 (3-12) | 4 (1-12) | 3 (1-10) |
| 1 prior line, n/n (%) | 18/473 (4) | 8/412 (2) | 10/57 (18) | 18/104 (17) | 0/365 (0) | 3/259 (1) | 15/210 (7) |
| 2 prior lines, n/n (%) | 86/473 (18) | 64/412 (16) | 22/57 (39) | 86/104 (83) | 0/365 (0) | 37/259 (14) | 49/210 (23) |
| ≥3 prior lines, n/n (%) | 369/473 (78) | 340/412 (83) | 25/57 (44) | 0/104 (0) | 365/365 (100) | 219/259 (85) | 146/210 (70) |
| Not reported, n | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Prior bendamustine, n or n/n (%) | 261/473 (55) | 236 (57) | 23 (40) | 40 (38) | 219 (60) | 259 (100) | 0 |
| Prior BTKi, n or n/n (%) | 415/472 (88) | 412 (100) | 0 | 72 (69) | 340 (93) | 236 (91) | 176 (84) |
| Prior auto-HCT, n (%) | 143 (30) | 121 (29) | 19 (33) | 22 (21) | 118 (32) | 50 (19) | 90 (43) |
| Bridging therapy (any type), n/n (%)† | 208/460 (45) | 194/402 (48) | 11/54 (20) | 32/101 (32) | 173/355 (49) | 118/252 (47) | 87/204 (43) |
| Not reported, n | 16 | 10 | 3 | 3 | 10 | 7 | 6 |
| Time from leukapheresis to infusion, median (IQR), d | 28.0 (26.0-34.0) | 29.0 (26.0-35.0) | 27.0 (25.0-31.0) | 28.0 (26.0-33.5) | 28.0 (26.0-35.0) | 29.0 (26.0-38.0) | 28.0 (26.0-33.0) |
| Planned infusion in outpatient setting, n (%) | 41 (9) | 36 (9) | 5 (9) | 11 (11) | 30 (8) | 27 (10) | 14 (7) |
CNS, central nervous system; ECOG PS, Eastern Cooperative Oncology Group performance status; HCT-CI, hematopoietic cell transplantation comorbidity index; LDH, lactate dehydrogenase; max, maximum; min, minimum.
Not including prior HCT.
Defined as anticancer treatment given between leukapheresis and lymphodepleting chemotherapy (including treatments initiated before leukapheresis); comprises systemic therapy (including bendamustine and BTKi), intrathecal therapy, radiation therapy, and surgery.