Patient characteristics at inclusion
| . | Cohort A: relapsed patients, ibrutinib and obinutuzumab (n = 9) . | Cohort B: relapsed patients, ibrutinib, obinutuzumab, and venetoclax (n = 24) . | Cohort C: untreated patients, ibrutinib, obinutuzumab, and venetoclax (n = 15) . |
|---|---|---|---|
| Age (y), median (range) | 64 (58-82) | 66 (45-76) | 65 (51-77) |
| Sex | |||
| Female | 3 (33) | 5 (21) | 9 (60) |
| Male | 6 (67) | 19 (79) | 6 (40) |
| No. of previous lines, median (range) | 1 (1, 4) | 1 (1, 3) | — |
| Median time from previous line of treatment (months) | 31 (1-65) | 24 (1-172) | — |
| Prior stem-cell transplantation | |||
| Yes | 7 (78) | 13 (54) | — |
| Stage of MCL at inclusion | |||
| II | 1 (11) | 3 (12) | 0 (0) |
| III-IV | 8 (89) | 21 (88) | 15 (100) |
| Bone marrow involved | |||
| No | 4 (44) | 13 (59) | 7 (47) |
| Yes | 5 (56) | 9 (41) | 8 (53) |
| Missing | — | 2 | — |
| MIPI score at inclusion | |||
| High risk | 1 (11) | 7 (29) | 4 (27) |
| Intermediate risk | 4 (44) | 8 (33) | 11 (73) |
| Low risk | 4 (44) | 9 (38) | 0 (0) |
| MIPIb score at inclusion | |||
| High risk | 5 (62%) | 11 (61%) | 6 (55%) |
| Intermediate risk | 3 (38%) | 7 (39%) | 5 (45%) |
| Missing | 1 | 6 | 4 |
| Tumor size >5 cm | |||
| No | 5 (56) | 15 (62) | 9 (60) |
| Yes | 4 (44) | 9 (38) | 6 (40) |
| ECOG performance-status | |||
| 0-1 | 8 (89) | 22 (92) | 15 (100) |
| 2 | 1 (11) | 2 (8) | 0 (0) |
| Blastic or pleomorphic | |||
| Blastic | 2 (22) | 4 (17) | 0 (0) |
| Pleomorphic MCL | 0 (0) | 1 (4) | 1 (7) |
| Missing | 0 (0) | 1 (4) | 0 (0) |
| Cytogenetic and molecular features | |||
| TP53 mutated (NGS) | 1 (11) | 5 (21) | 2 (13) |
| Not evaluable* | 2 | 7 | 1 |
| 17p deletion | 1 (11) | 2 (8) | 6 (40) |
| Not evaluable* | 5 | 18 | 5 |
| IGHV mutated (NGS) | 1 (11) | 7 (29) | 2 (13) |
| Not evaluable* | 2 | 8 | 3 |
| . | Cohort A: relapsed patients, ibrutinib and obinutuzumab (n = 9) . | Cohort B: relapsed patients, ibrutinib, obinutuzumab, and venetoclax (n = 24) . | Cohort C: untreated patients, ibrutinib, obinutuzumab, and venetoclax (n = 15) . |
|---|---|---|---|
| Age (y), median (range) | 64 (58-82) | 66 (45-76) | 65 (51-77) |
| Sex | |||
| Female | 3 (33) | 5 (21) | 9 (60) |
| Male | 6 (67) | 19 (79) | 6 (40) |
| No. of previous lines, median (range) | 1 (1, 4) | 1 (1, 3) | — |
| Median time from previous line of treatment (months) | 31 (1-65) | 24 (1-172) | — |
| Prior stem-cell transplantation | |||
| Yes | 7 (78) | 13 (54) | — |
| Stage of MCL at inclusion | |||
| II | 1 (11) | 3 (12) | 0 (0) |
| III-IV | 8 (89) | 21 (88) | 15 (100) |
| Bone marrow involved | |||
| No | 4 (44) | 13 (59) | 7 (47) |
| Yes | 5 (56) | 9 (41) | 8 (53) |
| Missing | — | 2 | — |
| MIPI score at inclusion | |||
| High risk | 1 (11) | 7 (29) | 4 (27) |
| Intermediate risk | 4 (44) | 8 (33) | 11 (73) |
| Low risk | 4 (44) | 9 (38) | 0 (0) |
| MIPIb score at inclusion | |||
| High risk | 5 (62%) | 11 (61%) | 6 (55%) |
| Intermediate risk | 3 (38%) | 7 (39%) | 5 (45%) |
| Missing | 1 | 6 | 4 |
| Tumor size >5 cm | |||
| No | 5 (56) | 15 (62) | 9 (60) |
| Yes | 4 (44) | 9 (38) | 6 (40) |
| ECOG performance-status | |||
| 0-1 | 8 (89) | 22 (92) | 15 (100) |
| 2 | 1 (11) | 2 (8) | 0 (0) |
| Blastic or pleomorphic | |||
| Blastic | 2 (22) | 4 (17) | 0 (0) |
| Pleomorphic MCL | 0 (0) | 1 (4) | 1 (7) |
| Missing | 0 (0) | 1 (4) | 0 (0) |
| Cytogenetic and molecular features | |||
| TP53 mutated (NGS) | 1 (11) | 5 (21) | 2 (13) |
| Not evaluable* | 2 | 7 | 1 |
| 17p deletion | 1 (11) | 2 (8) | 6 (40) |
| Not evaluable* | 5 | 18 | 5 |
| IGHV mutated (NGS) | 1 (11) | 7 (29) | 2 (13) |
| Not evaluable* | 2 | 8 | 3 |
ECOG, Eastern Cooperative Oncology Group; MIPIb, biologic Mantle Cell Lymphoma International Prognostic Index; NGS, next generation sequencing.
Not evaluated; IGHV mutation status and TP53 screening by NGS is assessed in blood and/or bone marrow only if clonal B cells are detectable by flow or PCR. Assessment is not evaluated if no clonal infiltration; array CGH is performed only when patients show >20% infiltration by flow the sample (blood and/or bone marrow) and is not evaluated if <20% infiltration.