Baseline characteristics and detail of CD19 CAR T-cell therapy of 33 patients who had no evidence of disease at the time of CAR T-cell infusion and 330 patients with persistent disease at the time of CAR T-cell therapy
| Parameters . | Patient without detectable disease N = 33 (%) . | Patient with detectable disease N = 330 (%) . | P value . |
|---|---|---|---|
| Median age at CAR T-cell infusion (y, IQR) | 64 (58-70) | 63 (55-70) | .3 |
| Male gender | 19 (57.6) | 221 (67.0) | .3 |
| Histological diagnosis | .6 | ||
| De novo DLBCL | 23 (69.6) | 232 (70.4) | |
| High-grade B-cell lymphoma | 5 (15.2) | 29 (8.8) | |
| Transformed DLBCL | 5 (15.2) | 63 (19.0) | |
| Primary mediastinal B-cell lymphoma | 0 (0) | 3 (0.9) | |
| Missing | 0 (0) | 3 (0.9) | |
| Double hit/triple hit by fluorescent in-situ hybridization | 5 (15.2) | 68 (20.5) | .8 |
| Response to first-line immunochemotherapy | .002 | ||
| Relapsed disease | 30 (90.9) | 200 (60.7) | |
| Primary refractory disease | 3 (9.1) | 107 (32.3) | |
| Missing | 0 (0) | 23 (6.9) | |
| Median LDH level before leukapheresis (U/L, IQR) | 234 (190-286) | 256 (189-377) | .2 |
| International Prognostic Index at the time of apheresis | .5 | ||
| 0-1 | 6 (18.2) | 58 (17.5) | |
| 2 | 11 (33.3) | 84 (25.4) | |
| 3 | 6 (18.2) | 110 (33.2) | |
| 4-5 | 5 (15.2) | 45 (13.6) | |
| Missing | 5 (15.2) | 33 (10.3) | |
| CAR T-cell product | <.001 | ||
| Axi-cel | 9 (27.3) | 197 (59.5) | |
| Tisa-cel | 24 (72.7) | 132 (40.2) | |
| Missing | 0 | 1 | |
| Median number of treatments before CAR T cells (lines, IQR) | 4 (3-5) | 3 (2-4) | .09 |
| Previous autologous stem cell transplant | 11 (33.3) | 75 (22.6) | .2 |
| Previous allogeneic hematopoietic cell transplant | 2 (6.1) | 6 (1.8) | .2 |
| Previous CD19 target therapy | 2 (6.1) | 12 (3.6) | .4 |
| Median LDH before initiation of lymphodepletion chemotherapy (U/L, IQR) | 192 (168-231) | 252 (183-396) | .002 |
| Median time from preinfusion PET/CT to the day of infusion (d, IQR) | 14 (10-19) | 15 (8-36) | >.9 |
| Treatment setting of CAR T cells | .2 | ||
| Inpatient | 20 (60.6) | 239 (72.5) | |
| Outpatient | 13 (39.4) | 91 (27.5) | |
| Occurrence of CRS | 12 (36.4) | 227 (68.8) | <.001 |
| Distribution of CRS grading | .01 | ||
| Grade 1 | 6 (18.2) | 117 (35.4) | |
| Grade 2 | 6 (18.2) | 90 (27.3) | |
| Grade 3 | 0 (0) | 13 (3.9) | |
| Grade 4 | 0 (0) | 7 (2.1) | |
| Median time from infusion to CRS (d, IQR) | 3 (1-3.5) | 3 (1-4) | .8 |
| Occurrence of ICAND | 2 (6.1) | 121 (36.7) | <.001 |
| Distribution of ICANS grading | .02 | ||
| Grade 1 | 1 (3.0) | 26 (7.9) | |
| Grade 2 | 0 (0) | 24 (7.3) | |
| Grade 3 | 0 (0) | 47 (14.0) | |
| Grade 4 | 1 (3.0) | 21 (6.4) | |
| Grade 5 | 0 (0) | 3 (0.9) | |
| Median time from infusion to ICANS (d, range) | 6.5 (6-7) | 5 (5-7) | .7 |
| Relapse or progress after CAR T-cell therapy | 13 (39.4) | 187 (56.5) | N/A∗ |
| Deceased at last follow-up | 6 (18.2) | 136 (41.1) | N/A∗ |
| Parameters . | Patient without detectable disease N = 33 (%) . | Patient with detectable disease N = 330 (%) . | P value . |
|---|---|---|---|
| Median age at CAR T-cell infusion (y, IQR) | 64 (58-70) | 63 (55-70) | .3 |
| Male gender | 19 (57.6) | 221 (67.0) | .3 |
| Histological diagnosis | .6 | ||
| De novo DLBCL | 23 (69.6) | 232 (70.4) | |
| High-grade B-cell lymphoma | 5 (15.2) | 29 (8.8) | |
| Transformed DLBCL | 5 (15.2) | 63 (19.0) | |
| Primary mediastinal B-cell lymphoma | 0 (0) | 3 (0.9) | |
| Missing | 0 (0) | 3 (0.9) | |
| Double hit/triple hit by fluorescent in-situ hybridization | 5 (15.2) | 68 (20.5) | .8 |
| Response to first-line immunochemotherapy | .002 | ||
| Relapsed disease | 30 (90.9) | 200 (60.7) | |
| Primary refractory disease | 3 (9.1) | 107 (32.3) | |
| Missing | 0 (0) | 23 (6.9) | |
| Median LDH level before leukapheresis (U/L, IQR) | 234 (190-286) | 256 (189-377) | .2 |
| International Prognostic Index at the time of apheresis | .5 | ||
| 0-1 | 6 (18.2) | 58 (17.5) | |
| 2 | 11 (33.3) | 84 (25.4) | |
| 3 | 6 (18.2) | 110 (33.2) | |
| 4-5 | 5 (15.2) | 45 (13.6) | |
| Missing | 5 (15.2) | 33 (10.3) | |
| CAR T-cell product | <.001 | ||
| Axi-cel | 9 (27.3) | 197 (59.5) | |
| Tisa-cel | 24 (72.7) | 132 (40.2) | |
| Missing | 0 | 1 | |
| Median number of treatments before CAR T cells (lines, IQR) | 4 (3-5) | 3 (2-4) | .09 |
| Previous autologous stem cell transplant | 11 (33.3) | 75 (22.6) | .2 |
| Previous allogeneic hematopoietic cell transplant | 2 (6.1) | 6 (1.8) | .2 |
| Previous CD19 target therapy | 2 (6.1) | 12 (3.6) | .4 |
| Median LDH before initiation of lymphodepletion chemotherapy (U/L, IQR) | 192 (168-231) | 252 (183-396) | .002 |
| Median time from preinfusion PET/CT to the day of infusion (d, IQR) | 14 (10-19) | 15 (8-36) | >.9 |
| Treatment setting of CAR T cells | .2 | ||
| Inpatient | 20 (60.6) | 239 (72.5) | |
| Outpatient | 13 (39.4) | 91 (27.5) | |
| Occurrence of CRS | 12 (36.4) | 227 (68.8) | <.001 |
| Distribution of CRS grading | .01 | ||
| Grade 1 | 6 (18.2) | 117 (35.4) | |
| Grade 2 | 6 (18.2) | 90 (27.3) | |
| Grade 3 | 0 (0) | 13 (3.9) | |
| Grade 4 | 0 (0) | 7 (2.1) | |
| Median time from infusion to CRS (d, IQR) | 3 (1-3.5) | 3 (1-4) | .8 |
| Occurrence of ICAND | 2 (6.1) | 121 (36.7) | <.001 |
| Distribution of ICANS grading | .02 | ||
| Grade 1 | 1 (3.0) | 26 (7.9) | |
| Grade 2 | 0 (0) | 24 (7.3) | |
| Grade 3 | 0 (0) | 47 (14.0) | |
| Grade 4 | 1 (3.0) | 21 (6.4) | |
| Grade 5 | 0 (0) | 3 (0.9) | |
| Median time from infusion to ICANS (d, range) | 6.5 (6-7) | 5 (5-7) | .7 |
| Relapse or progress after CAR T-cell therapy | 13 (39.4) | 187 (56.5) | N/A∗ |
| Deceased at last follow-up | 6 (18.2) | 136 (41.1) | N/A∗ |
LDH, lactate dehydrogenase; N/A, not applicable.
Analysis relapse and death were performed by Kaplan-Meier estimate and comparison between groups were done using log-rank analysis.