Demographics and baseline disease characteristics (liso-cel–treated set)
| . | Outpatients (n = 57) . | Inpatients (n = 25) . | Total (N = 82) . |
|---|---|---|---|
| Median age (range), y | 65 (28-83) | 69 (34-86) | 66 (28-86) |
| ≥65, n (%) | 29 (51) | 15 (60) | 44 (54) |
| ≥75, n (%) | 11 (19) | 5 (20) | 16 (20) |
| Male, n (%) | 39 (68) | 15 (60) | 54 (66) |
| Race, n (%) | |||
| White | 49 (86) | 20 (80) | 69 (84) |
| Other | 4 (7) | 3 (12) | 7 (9) |
| Unknown | 4 (7) | 2 (8) | 6 (7) |
| Histology, n (%) | |||
| DLBCL NOS | 37 (65) | 13 (52) | 50 (61) |
| tDLBCL from indolent histologies | 15 (26)∗ | 1 (4)† | 16 (20) |
| HGBCL‡ | 4 (7) | 11 (44) | 15 (18) |
| Primary mediastinal B-cell lymphoma | 1 (2) | 0 | 1 (1) |
| Secondary CNS lymphoma, n (%) | 0 | 2 (8) | 2 (2) |
| ECOG PS at screening, n (%) | |||
| 0 | 19 (33) | 8 (32) | 27 (33) |
| 1 | 38 (67) | 17 (68) | 55 (67) |
| Ann Arbor disease, n (%) | |||
| Stage I | 6 (11) | 0 | 6 (7) |
| Stage II | 10 (18) | 5 (20) | 15 (18) |
| Stage III | 18 (32) | 5 (20) | 23 (28) |
| Stage IV | 23 (40) | 15 (60) | 38 (46) |
| Median no. of prior lines of therapy (range) | 2 (2-4) | 2 (2-6) | 2 (2-6) |
| Received prior HSCT, n (%) | 11 (19) | 2 (8) | 13 (16) |
| Refractory to last prior therapy, n (%)§ | 51 (89) | 24 (96) | 75 (91) |
| Chemotherapy refractory,|| n (%) | 47 (82) | 21 (84) | 68 (83) |
| LDH ≥500 units per L,¶ n (%) | 15 (26) | 8 (32) | 23 (28) |
| SPD ≥50 cm2,¶ n (%) | 17 (31) | 13 (54) | 30 (38) |
| CRP ≥20 mg/L,¶ n (%) | 28 (49) | 16 (64) | 44 (54) |
| Received bridging therapy,# n (%) | 25 (44) | 19 (76) | 44 (54) |
| . | Outpatients (n = 57) . | Inpatients (n = 25) . | Total (N = 82) . |
|---|---|---|---|
| Median age (range), y | 65 (28-83) | 69 (34-86) | 66 (28-86) |
| ≥65, n (%) | 29 (51) | 15 (60) | 44 (54) |
| ≥75, n (%) | 11 (19) | 5 (20) | 16 (20) |
| Male, n (%) | 39 (68) | 15 (60) | 54 (66) |
| Race, n (%) | |||
| White | 49 (86) | 20 (80) | 69 (84) |
| Other | 4 (7) | 3 (12) | 7 (9) |
| Unknown | 4 (7) | 2 (8) | 6 (7) |
| Histology, n (%) | |||
| DLBCL NOS | 37 (65) | 13 (52) | 50 (61) |
| tDLBCL from indolent histologies | 15 (26)∗ | 1 (4)† | 16 (20) |
| HGBCL‡ | 4 (7) | 11 (44) | 15 (18) |
| Primary mediastinal B-cell lymphoma | 1 (2) | 0 | 1 (1) |
| Secondary CNS lymphoma, n (%) | 0 | 2 (8) | 2 (2) |
| ECOG PS at screening, n (%) | |||
| 0 | 19 (33) | 8 (32) | 27 (33) |
| 1 | 38 (67) | 17 (68) | 55 (67) |
| Ann Arbor disease, n (%) | |||
| Stage I | 6 (11) | 0 | 6 (7) |
| Stage II | 10 (18) | 5 (20) | 15 (18) |
| Stage III | 18 (32) | 5 (20) | 23 (28) |
| Stage IV | 23 (40) | 15 (60) | 38 (46) |
| Median no. of prior lines of therapy (range) | 2 (2-4) | 2 (2-6) | 2 (2-6) |
| Received prior HSCT, n (%) | 11 (19) | 2 (8) | 13 (16) |
| Refractory to last prior therapy, n (%)§ | 51 (89) | 24 (96) | 75 (91) |
| Chemotherapy refractory,|| n (%) | 47 (82) | 21 (84) | 68 (83) |
| LDH ≥500 units per L,¶ n (%) | 15 (26) | 8 (32) | 23 (28) |
| SPD ≥50 cm2,¶ n (%) | 17 (31) | 13 (54) | 30 (38) |
| CRP ≥20 mg/L,¶ n (%) | 28 (49) | 16 (64) | 44 (54) |
| Received bridging therapy,# n (%) | 25 (44) | 19 (76) | 44 (54) |
CLL, chronic lymphocytic leukemia; CNS, central nervous system; CRP, C-reactive protein; DLBCL, diffuse LBCL; ECOG PS, Eastern Cooperative Oncology Group performance status; FL, follicular lymphoma; HGBCL, high-grade B-cell lymphoma; LDH, lactate dehydrogenase; NOS, not otherwise specified; PD, progressive disease; SD, stable disease; SLL, small lymphocytic lymphoma; SPD, sum of the product of perpendicular diameters; tDLBCL, transformed diffuse LBCL.
Transformed from FL (n = 14) and Waldenström macroglobulinemia (n = 1).
Transformed from CLL/SLL (n = 1).
Includes high-grade lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology.
Best response of PR, SD, or PD to last systemic or transplant treatment with curative intent.
Defined as experiencing SD or PD to the last treatment with curative intent (ie, systemic or transplant) that patients received before coming on this study or relapsed <12 months after autologous HSCT; patients who were not chemotherapy refractory were considered to be chemotherapy sensitive.
Percentages are based on number of patients with nonmissing results.
Types of bridging therapy included systemic treatment only (n = 23), radiotherapy only (n = 1), or both systemic treatment and radiotherapy (n = 1) in the outpatient group and systemic treatment only (n = 19) in the inpatient group.