Responses according to Cheson 99 criteria, Lugano criteria, and MRD status
| . | 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) . |
|---|---|---|---|
| Response at end of cycle 2 (Cheson 99) | |||
| CR/CRu | 3 (34) | 9 (38) | 8 (53) |
| PR | 2 (22) | 11 (46) | 7 (47) |
| SD | 2 (22) | 1 (4) | — |
| PD | 1 (11) | 3 (12) | — |
| Missing | 1 (11) | — | — |
| Response at end of cycle 4 (Cheson 99) | |||
| CR/CRu | 4 (44) | 15 (62) | 12 (80) |
| PR | 3 (34) | 4 (17) | 2 (13) |
| SD | 1 (11) | 1 (4) | — |
| PD | 1 (11) | 4 (17) | 1 (7) |
| Response at end of cycle 6 (Cheson 99) | |||
| CR/CRu | 7 (78) | 16 (67) | 12 (80) |
| PR | 0 (0) | 2 (8) | 2 (13) |
| SD | 1 (11) | — | — |
| PD | 1 (11) | 4 (17) | 1 (7) |
| Not done | — | 2 (8)† | — |
| Response at end of cycle 6 (Lugano) | |||
| CR | 7 (78) | 16 (67) | 13 (86) |
| PR | 1 (11) | 1 (4) | 1 (7) |
| PD | 1 (11) | 5 (21) | 1 (7) |
| Not done | — | 2 (8)† | — |
| MRD in blood at end of cycle 3 | |||
| Negative | 4 (44) | 10 (42) | 12 (80) |
| Positive | 2 (22) | 4 (17) | — |
| Not evaluable for MRD* | 2 (22) | 7 (29) | 3 (20) |
| Progression before end of cycle 3 | 1 (11) | 3 (12) | — |
| MRD in blood at end of cycle 6 | |||
| Negative | 4 (44) | 10 (42) | 11 (73) |
| Positive | 2 (22) | 3 (12) | — |
| Not evaluable for MRD* | 2 (22) | 7 (29)† | 2 (13) |
| Progression before end cycle 6 | 1 (11) | 4 (17) | 1 (7) |
| Missing sample | — | — | 1 (7) |
| MRD in BM at end of cycle 6 | |||
| Negative | 4 (44) | 9 (38) | 10 (67) |
| Positive | 1 (11) | 3 (12) | — |
| Not evaluable for MRD* | 2 (22) | 7 (29)† | 2 (13) |
| Progression before end cycle 6 | 1 (11) | 4 (17) | 1 (7) |
| Missing sample | 1 (11) | 1 (4) | 2 (13) |
| . | 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) . |
|---|---|---|---|
| Response at end of cycle 2 (Cheson 99) | |||
| CR/CRu | 3 (34) | 9 (38) | 8 (53) |
| PR | 2 (22) | 11 (46) | 7 (47) |
| SD | 2 (22) | 1 (4) | — |
| PD | 1 (11) | 3 (12) | — |
| Missing | 1 (11) | — | — |
| Response at end of cycle 4 (Cheson 99) | |||
| CR/CRu | 4 (44) | 15 (62) | 12 (80) |
| PR | 3 (34) | 4 (17) | 2 (13) |
| SD | 1 (11) | 1 (4) | — |
| PD | 1 (11) | 4 (17) | 1 (7) |
| Response at end of cycle 6 (Cheson 99) | |||
| CR/CRu | 7 (78) | 16 (67) | 12 (80) |
| PR | 0 (0) | 2 (8) | 2 (13) |
| SD | 1 (11) | — | — |
| PD | 1 (11) | 4 (17) | 1 (7) |
| Not done | — | 2 (8)† | — |
| Response at end of cycle 6 (Lugano) | |||
| CR | 7 (78) | 16 (67) | 13 (86) |
| PR | 1 (11) | 1 (4) | 1 (7) |
| PD | 1 (11) | 5 (21) | 1 (7) |
| Not done | — | 2 (8)† | — |
| MRD in blood at end of cycle 3 | |||
| Negative | 4 (44) | 10 (42) | 12 (80) |
| Positive | 2 (22) | 4 (17) | — |
| Not evaluable for MRD* | 2 (22) | 7 (29) | 3 (20) |
| Progression before end of cycle 3 | 1 (11) | 3 (12) | — |
| MRD in blood at end of cycle 6 | |||
| Negative | 4 (44) | 10 (42) | 11 (73) |
| Positive | 2 (22) | 3 (12) | — |
| Not evaluable for MRD* | 2 (22) | 7 (29)† | 2 (13) |
| Progression before end cycle 6 | 1 (11) | 4 (17) | 1 (7) |
| Missing sample | — | — | 1 (7) |
| MRD in BM at end of cycle 6 | |||
| Negative | 4 (44) | 9 (38) | 10 (67) |
| Positive | 1 (11) | 3 (12) | — |
| Not evaluable for MRD* | 2 (22) | 7 (29)† | 2 (13) |
| Progression before end cycle 6 | 1 (11) | 4 (17) | 1 (7) |
| Missing sample | 1 (11) | 1 (4) | 2 (13) |
BM, bone marrow; CRu, complete remission unconfirmed; PD; progression disease; PR, partial response; SD, stable disease.
Not evaluable; MRD assays are performed only in patients with clonal disease that is detectable by ASO-qPCR to sensitivity of 10−4/10−5. Assay is not evaluated if this is not possible.
Two patients were allografted before cycle 6.