Baseline characteristics of the infused patients in the present series and in the ZUMA-2 trial
| . | Infused (N=33) . | ZUMA-2 (N=68) . |
|---|---|---|
| Sex, n (%) | ||
| Male | 29 (88) | 57 (84) |
| Female | 4 (12) | 11 (16) |
| Age, median y (range) | 67 (47-79) | 65 (38-79) |
| ≥65 | 23 (70) | 39 (57) |
| <65 | 10 (30) | 29 (43) |
| Prior lines, median (range) | 2 (1-8) | 3 (1-5) |
| >2 prior lines | 15 (45) | 55 (81) |
| ≤2 prior lines | 18 (55) | 13 (19) |
| Primary refractory,*n (%) | ||
| Yes | 7 (21) | † |
| No | 26 (79) | |
| Previous auto-HCT, n (%) | ||
| Yes | 12 (36) | 29 (43) |
| No | 21 (64) | 39 (57) |
| Previous allo-HCT, n (%) | ||
| Yes | 5 (15) | 0 (0) |
| No | 28 (85) | 68 (100) |
| Best response to previous ibrutinib, n (%) | ||
| CR | 11 (34) | † |
| PR | 10 (30) | |
| SD/PD | 8 (24) | |
| Not available | 4 (12) | |
| Prior bendamustine therapy, n (%) | ||
| Yes | 14 (42) | 37 (54) |
| No | 19 (58) | 31 (46) |
| Prior rituximab maintenance, n (%) | ||
| Yes | 14 (42) | † |
| No | 19 (58) | |
| Morphology, n (%) | ||
| Classical | 22 (67) | 36 (53) |
| Blastoid/pleomorphic | 9 (27) | 21 (31) |
| Not available | 2 (6) | 11 (16) |
| TP53 status, n (%) | ||
| Mutated | 4 (12) | 6 (9) |
| Unmutated | 11 (33) | 30 (44) |
| Not available | 18 (55) | 32 (47) |
| Ki67 index>30%, n (%) | ||
| Yes | 16 (49) | 40 (59) |
| No | 3 (9) | 9 (13) |
| Not available | 14 (42) | 19 (28) |
| Stage, n (%)‡ | ||
| I-II | 4 (12) | 2 (15) |
| III-IV | 29 (88) | 58 (85) |
| s-MIPI, n (%) | ||
| Low | 8 (24) | 28 (41) |
| Intermediate/high | 23 (70) | 38 (56) |
| Not available | 2 (6) | 2 (3) |
| Extranodal disease, n (%)‡ | ||
| Yes | 26 (79) | 37 (62) |
| No | 7 (21) | 23 (38) |
| Bone marrow infiltration, n (%) | ||
| Yes | 10 (30) | 37 (54) |
| No | 23 (70) | 31 (46) |
| Peripheral blood involvement, n (%) | ||
| Yes | 6 (18) | † |
| No | 27 (82) | |
| LDH, n (%)‡ | ||
| >ULN | 14 (42) | 23 (38) |
| ≤ULN | 19 (56) | 35 (59) |
| Not available | 0 (0) | 2 (3) |
| ECOG, n (%) | ||
| 0 | 15 (45) | 44 (65) |
| ≥1 | 18 (55) | 24 (35) |
| . | Infused (N=33) . | ZUMA-2 (N=68) . |
|---|---|---|
| Sex, n (%) | ||
| Male | 29 (88) | 57 (84) |
| Female | 4 (12) | 11 (16) |
| Age, median y (range) | 67 (47-79) | 65 (38-79) |
| ≥65 | 23 (70) | 39 (57) |
| <65 | 10 (30) | 29 (43) |
| Prior lines, median (range) | 2 (1-8) | 3 (1-5) |
| >2 prior lines | 15 (45) | 55 (81) |
| ≤2 prior lines | 18 (55) | 13 (19) |
| Primary refractory,*n (%) | ||
| Yes | 7 (21) | † |
| No | 26 (79) | |
| Previous auto-HCT, n (%) | ||
| Yes | 12 (36) | 29 (43) |
| No | 21 (64) | 39 (57) |
| Previous allo-HCT, n (%) | ||
| Yes | 5 (15) | 0 (0) |
| No | 28 (85) | 68 (100) |
| Best response to previous ibrutinib, n (%) | ||
| CR | 11 (34) | † |
| PR | 10 (30) | |
| SD/PD | 8 (24) | |
| Not available | 4 (12) | |
| Prior bendamustine therapy, n (%) | ||
| Yes | 14 (42) | 37 (54) |
| No | 19 (58) | 31 (46) |
| Prior rituximab maintenance, n (%) | ||
| Yes | 14 (42) | † |
| No | 19 (58) | |
| Morphology, n (%) | ||
| Classical | 22 (67) | 36 (53) |
| Blastoid/pleomorphic | 9 (27) | 21 (31) |
| Not available | 2 (6) | 11 (16) |
| TP53 status, n (%) | ||
| Mutated | 4 (12) | 6 (9) |
| Unmutated | 11 (33) | 30 (44) |
| Not available | 18 (55) | 32 (47) |
| Ki67 index>30%, n (%) | ||
| Yes | 16 (49) | 40 (59) |
| No | 3 (9) | 9 (13) |
| Not available | 14 (42) | 19 (28) |
| Stage, n (%)‡ | ||
| I-II | 4 (12) | 2 (15) |
| III-IV | 29 (88) | 58 (85) |
| s-MIPI, n (%) | ||
| Low | 8 (24) | 28 (41) |
| Intermediate/high | 23 (70) | 38 (56) |
| Not available | 2 (6) | 2 (3) |
| Extranodal disease, n (%)‡ | ||
| Yes | 26 (79) | 37 (62) |
| No | 7 (21) | 23 (38) |
| Bone marrow infiltration, n (%) | ||
| Yes | 10 (30) | 37 (54) |
| No | 23 (70) | 31 (46) |
| Peripheral blood involvement, n (%) | ||
| Yes | 6 (18) | † |
| No | 27 (82) | |
| LDH, n (%)‡ | ||
| >ULN | 14 (42) | 23 (38) |
| ≤ULN | 19 (56) | 35 (59) |
| Not available | 0 (0) | 2 (3) |
| ECOG, n (%) | ||
| 0 | 15 (45) | 44 (65) |
| ≥1 | 18 (55) | 24 (35) |
Allo-HCT, allogeneic hematopoietic cell transplantation; auto-HCT, autologous hematopoietic cell transplantation; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; MIPI, Mantle Cell Lymphoma International Prognostic Index; ULN, upper limit of normal.
Information not available owing to different definitions or cutoffs between the ZUMA-2 trial and this study.
Never achieving complete remission with any line of treatment.
Reported on the 60 patients of the primary efficacy analysis set.