Baseline characteristics at time of leukapheresis for all treated patients (N = 122) and stratified by 3-month response
| Characteristics* . | All patients (N = 122), N (%) . | 3-mo complete response (N = 50†), N (%) . | 3-mo no complete response (N = 70†), N (%) . | P‡ . |
|---|---|---|---|---|
| Median age (range) | 60.5 (18-88) | 59.5 (18-84) | 63 (24-88) | .29 |
| Age > 60 y | 61 (50) | 23 (46) | 38 (54) | .46 |
| Male sex | 87 (71) | 33 (66) | 54 (77) | .22 |
| Stage III/IV | 99 (81) | 39 (78) | 58 (83) | .64 |
| Extranodal sites > 1 | 77 (63) | 29 (53) | 47 (72) | .036 |
| ECOG performance status | ||||
| 0-1 | 107 (88) | 46 (92) | 59 (84) | .40 |
| 2 | 11 (9) | 4 (8) | 7 (10) | |
| 3 | 4 (3) | 0 (0) | 4 (6) | |
| LDH | ||||
| >upper limit normal | 92 (75) | 35 (70) | 55 (79) | .30 |
| >2× upper limit normal | 21 (17) | 6 (12) | 14 (20) | .32 |
| International prognostic index 3-5 | 75 (62) | 27 (54) | 47 (67) | .183 |
| Histology | ||||
| Diffuse LBCL | 72 (59) | 30 (60) | 42 (60) | .02 |
| Transformed indolent | 43 (35) | 15 (30) | 28 (40) | |
| Primary mediastinal | 7 (6) | 5 (10) | 0 (0) | |
| Bulky disease | ||||
| >5 cm | 57/121 (47) | 20/49 (41) | 35 (50) | .36 |
| >10 cm | 19/121 (16) | 6/49 (12) | 11 (16) | .79 |
| Double expressor | 34/87 (39) | 13/36 (36) | 21/51 (41) | .66 |
| Double hit | 17/97 (18) | 5/39 (14) | 12/56 (21) | .42 |
| Cell-of-origin | ||||
| GCB | 72/113 (64) | 28/44 (64) | 43/67 (64) | 1.0 |
| Non-GCB | 41/113 (36) | 16/44 (36) | 24/67 (36) | |
| Median prior lines of therapy (range) | 3 (2-11) | 3 (2-11) | 3 (2-10) | .36 |
| Prior lines > 2 | 88 (72) | 34 (68) | 53 (76) | .41 |
| Prior autologous stem cell transplant | 28 (23) | 13 (26) | 14 (20) | .51 |
| Primary refractory to frontline therapy§ | 77 (63) | 28 (56) | 47 (67) | .25 |
| Received bridging therapy | 66 (45) | 24 (48) | 40 (57) | .36 |
| CART19 product received | ||||
| Axicabtagene ciloleucel | 112 (92), 4/112 OOS | 48 (96) | 62 (89) | .19 |
| Tisagenlecleucel | 10 (8), 1/10 OOS | 2 (4) | 8 (11) | |
| Grade 3-4 cytokine release syndrome | 10 (8) | 3 (6) | 6 (9) | .73 |
| Grade 3-4 neurotoxicity | 41 (34) | 17 (34) | 23 (33) | 1.0 |
| Characteristics* . | All patients (N = 122), N (%) . | 3-mo complete response (N = 50†), N (%) . | 3-mo no complete response (N = 70†), N (%) . | P‡ . |
|---|---|---|---|---|
| Median age (range) | 60.5 (18-88) | 59.5 (18-84) | 63 (24-88) | .29 |
| Age > 60 y | 61 (50) | 23 (46) | 38 (54) | .46 |
| Male sex | 87 (71) | 33 (66) | 54 (77) | .22 |
| Stage III/IV | 99 (81) | 39 (78) | 58 (83) | .64 |
| Extranodal sites > 1 | 77 (63) | 29 (53) | 47 (72) | .036 |
| ECOG performance status | ||||
| 0-1 | 107 (88) | 46 (92) | 59 (84) | .40 |
| 2 | 11 (9) | 4 (8) | 7 (10) | |
| 3 | 4 (3) | 0 (0) | 4 (6) | |
| LDH | ||||
| >upper limit normal | 92 (75) | 35 (70) | 55 (79) | .30 |
| >2× upper limit normal | 21 (17) | 6 (12) | 14 (20) | .32 |
| International prognostic index 3-5 | 75 (62) | 27 (54) | 47 (67) | .183 |
| Histology | ||||
| Diffuse LBCL | 72 (59) | 30 (60) | 42 (60) | .02 |
| Transformed indolent | 43 (35) | 15 (30) | 28 (40) | |
| Primary mediastinal | 7 (6) | 5 (10) | 0 (0) | |
| Bulky disease | ||||
| >5 cm | 57/121 (47) | 20/49 (41) | 35 (50) | .36 |
| >10 cm | 19/121 (16) | 6/49 (12) | 11 (16) | .79 |
| Double expressor | 34/87 (39) | 13/36 (36) | 21/51 (41) | .66 |
| Double hit | 17/97 (18) | 5/39 (14) | 12/56 (21) | .42 |
| Cell-of-origin | ||||
| GCB | 72/113 (64) | 28/44 (64) | 43/67 (64) | 1.0 |
| Non-GCB | 41/113 (36) | 16/44 (36) | 24/67 (36) | |
| Median prior lines of therapy (range) | 3 (2-11) | 3 (2-11) | 3 (2-10) | .36 |
| Prior lines > 2 | 88 (72) | 34 (68) | 53 (76) | .41 |
| Prior autologous stem cell transplant | 28 (23) | 13 (26) | 14 (20) | .51 |
| Primary refractory to frontline therapy§ | 77 (63) | 28 (56) | 47 (67) | .25 |
| Received bridging therapy | 66 (45) | 24 (48) | 40 (57) | .36 |
| CART19 product received | ||||
| Axicabtagene ciloleucel | 112 (92), 4/112 OOS | 48 (96) | 62 (89) | .19 |
| Tisagenlecleucel | 10 (8), 1/10 OOS | 2 (4) | 8 (11) | |
| Grade 3-4 cytokine release syndrome | 10 (8) | 3 (6) | 6 (9) | .73 |
| Grade 3-4 neurotoxicity | 41 (34) | 17 (34) | 23 (33) | 1.0 |
ECOG, Eastern Cooperative Oncology Group; GCB, germinal center B-cell; OOS, out of specification product.
All baseline characteristics were recorded at time of leukapheresis.
Two patients were excluded from 3-month response assessment because they were lost to follow-up.
By Fisher’s exact test for categorical variables and Wilcoxon rank sum test for continuous variables.
Defined as nonresponse or progression of disease within 6 months of frontline therapy.