Table 1.
Patient demographics and baseline disease characteristics
| Part 1 MR (n = 13) | Part 2 MRV (n = 32) | Total (N = 45) | |
|---|---|---|---|
| Median age, years (range) | 61.0 (37–86) | 65.5 (28–81) | 64.0 (28–86) |
| Male, n (%) | 10 (77) | 19 (59) | 29 (64) |
| Race, n (%) | |||
| White | 12 (92) | 28 (88) | 40 (89) |
| Black | 0 | 2 (6) | 2 (4) |
| Asian | 1 (8) | 0 | 1 (2) |
| Other | 0 | 1 (3) | 1 (2) |
| Not reported | 0 | 1 (3) | 1 (2) |
| ECOG performance status, n (%) | |||
| 0 | 7 (54) | 15 (47) | 22 (49) |
| 1 | 4 (31) | 13 (41) | 17 (38) |
| 2 | 2 (15) | 4 (13) | 6 (13) |
| Median international prognostic index score (range) | 3 (1–4) | 2 (0–4) | 2 (0–4) |
| Ann Arbor stage, n (%) | |||
| I | 1 (8) | 2 (6) | 3 (7) |
| II | 0 | 5 (16) | 5 (11) |
| III | 3 (23) | 11 (34) | 14 (31) |
| IV | 7 (54) | 4 (13) | 11 (24) |
| Other | 2 (15) | 5 (16) | 7 (16) |
| Unknown | 0 | 5 (16) | 5 (11) |
| Disease type, n (%) | |||
| DLBCL not otherwise specified | 8 (62) | 27 (84)b | 35 (78) |
| MCL | 3 (23) | 3 (9) | 6 (13) |
| DLBCL associated with chronic inflammation | 0 | 1 (3)b | 1 (2) |
| B-cell lymphoplasmacytic lymphoma/immunocytoma | 1 (8) | 0 | 1 (2) |
| Othera | 1 (8) | 1 (3) | 2 (4) |
| COO classification, n (%) | |||
| GCB | 2 (15) | 7 (22) | 9 (20) |
| Non-GCB | 8 (62) | 12 (38) | 20 (44) |
| Unknown or indeterminate | 3 (23) | 13 (40) | 16 (36) |
| Median time from diagnosis, years (range) | 1.5 (0.3–10.4) | 1.7 (0.1–13.8) | 1.6(0.1–13.8) |
| Evidence of extranodal involvement, n (%) | |||
| Yes | 11 (85) | 28 (88) | 39 (87) |
| No | 0 | 0 | 0 |
| Unknown | 2 (15) | 4 (13) | 6 (13) |
Abbreviations: COO, cell of origin; DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group; GCB, germinal center B-cell; MR, alisertib plus rituximab; MRV, alisertib plus rituximab plus vincristine.
TFL to “double-hit” lymphoma and follicular B-cell lymphoma transformed to DLBCL.
Two patients with DLBCL not otherwise specified and one with DLBCL with chronic inflammation violated protocol entry criteria as they were not CD20 positive. The 2 patients with DLBCL not otherwise specified discontinued in cycle 1, one with symptomatic deterioration and one with progressive disease; the patient with inflammation-associated disease withdrew consent for further treatment at cycle 4 after having stable disease.