Baseline demographic and clinical characteristics of patients treated with CAR T cells
| Characteristic . | All patients (n = 258) . | Training cohort (n = 58) . | European validation cohort (n = 91) . | United States validation cohort (n = 109) . |
|---|---|---|---|---|
| Median age, y (range) | 63 (19-83) | 59.5 (19-74) | 62 (27-83) | 64 (19-79) |
| Median no. of previous lines of therapy (range) | 3 (2-11) | 4 (2-9) | 3 (2-9) | 3 (2-11) |
| Previous ASCT | 69 (27) | 22 (38) | 27 (30) | 20 (18) |
| CAR product | ||||
| 4-1BB (tisa-cel) | 88 (34) | 17 (29) | 51 (56) | 20 (18) |
| CD28z (axi-cel) | 170 (66) | 41 (71) | 40 (44) | 89 (82) |
| Disease entity | ||||
| DLBCL | 176 (68) | 38 (65) | 57 (63) | 81 (74) |
| PMBCL | 15 (6) | 5 (9) | 6 (6) | 4 (4) |
| Transformed lymphoma* | 67 (26) | 15 (26) | 28 (31) | 24 (22) |
| Complete blood count | ||||
| Median ANC cells per µL (95% CI) | 2540 (2310-2730) | 2005 (1620-2640) | 2320 (1840-2660) | 3050 (2540-3530) |
| Median platelet count, g/L (95% CI) | 164 (152-178) | 152.5 (118-180) | 171 (146-200) | 164 (152-178) |
| Median hemoglobin, g/dL (95% CI) | 10.1 (9.7-10.4) | 10.1 (9.5-10.3) | 10.0 (9.3-10.6) | 10.3 (9.6-11.0) |
| ANC <1000 cells per µL | 38 (15) | 12 (21) | 13 (14) | 13 (12) |
| Platelet count <75 g/L | 44 (17) | 14 (24) | 15 (16) | 15 (14) |
| Hemoglobin <8 g/dL | 32 (12) | 12 (21) | 6 (7) | 14 (13) |
| Hematologic exclusion criteria were met† | 71 (28) | 23 (40) | 24 (26) | 24 (22) |
| Median markers of tumor burden and inflammation (95% CI) | ||||
| Lactate dehydrogenase, U/L | 276 (260-302) | 271 (245-381) | 302 (273-328) | 258 (237-297) |
| C-reactive protein, mg/dL | 1.02 (0.80-1.40) | 1.55 (0.80-2.62) | 1.02 (0.76-1.50) | 0.81 (0.48-1.29) |
| Ferritin, ng/mL | 501 (378-647) | 821 (576-1203) | 454 (310-647) | 378 (289-573) |
| Characteristic . | All patients (n = 258) . | Training cohort (n = 58) . | European validation cohort (n = 91) . | United States validation cohort (n = 109) . |
|---|---|---|---|---|
| Median age, y (range) | 63 (19-83) | 59.5 (19-74) | 62 (27-83) | 64 (19-79) |
| Median no. of previous lines of therapy (range) | 3 (2-11) | 4 (2-9) | 3 (2-9) | 3 (2-11) |
| Previous ASCT | 69 (27) | 22 (38) | 27 (30) | 20 (18) |
| CAR product | ||||
| 4-1BB (tisa-cel) | 88 (34) | 17 (29) | 51 (56) | 20 (18) |
| CD28z (axi-cel) | 170 (66) | 41 (71) | 40 (44) | 89 (82) |
| Disease entity | ||||
| DLBCL | 176 (68) | 38 (65) | 57 (63) | 81 (74) |
| PMBCL | 15 (6) | 5 (9) | 6 (6) | 4 (4) |
| Transformed lymphoma* | 67 (26) | 15 (26) | 28 (31) | 24 (22) |
| Complete blood count | ||||
| Median ANC cells per µL (95% CI) | 2540 (2310-2730) | 2005 (1620-2640) | 2320 (1840-2660) | 3050 (2540-3530) |
| Median platelet count, g/L (95% CI) | 164 (152-178) | 152.5 (118-180) | 171 (146-200) | 164 (152-178) |
| Median hemoglobin, g/dL (95% CI) | 10.1 (9.7-10.4) | 10.1 (9.5-10.3) | 10.0 (9.3-10.6) | 10.3 (9.6-11.0) |
| ANC <1000 cells per µL | 38 (15) | 12 (21) | 13 (14) | 13 (12) |
| Platelet count <75 g/L | 44 (17) | 14 (24) | 15 (16) | 15 (14) |
| Hemoglobin <8 g/dL | 32 (12) | 12 (21) | 6 (7) | 14 (13) |
| Hematologic exclusion criteria were met† | 71 (28) | 23 (40) | 24 (26) | 24 (22) |
| Median markers of tumor burden and inflammation (95% CI) | ||||
| Lactate dehydrogenase, U/L | 276 (260-302) | 271 (245-381) | 302 (273-328) | 258 (237-297) |
| C-reactive protein, mg/dL | 1.02 (0.80-1.40) | 1.55 (0.80-2.62) | 1.02 (0.76-1.50) | 0.81 (0.48-1.29) |
| Ferritin, ng/mL | 501 (378-647) | 821 (576-1203) | 454 (310-647) | 378 (289-573) |
All data represent n (%), unless otherwise specified.
ASCT, autologous stem cell transplantation; DLBCL, diffuse large B-cell lymphoma; PMBCL, primary mediastinal B-cell lymphoma.
The following types of lymphoma were transformed: chronic lymphocytic leukemia, follicular lymphoma, Hodgkin lymphoma, mucosa-associated lymphoid tissue lymphoma, and mantle cell lymphoma.
Hematologic exclusion criteria from the JULIET and ZUMA-1 trials were used for the study cohort at lymphodepletion.