Table 1.
Demographics and disease history by phase/cohort/group for phases 1 and 2
| Phase 1 |
Phase 2 |
||||||
|---|---|---|---|---|---|---|---|
| Cohort 1 (n = 6) | Cohort 2 (n = 7) | Total (n = 13) | Group 1 (n = 23) | Group 2 (n = 21) | Group 3 (n = 24) | Total (n = 68) | |
| Median age, y (range) | 78.5 (70-91) | 61.0 (52-80) | 72.0 (52-91) | 63.0 (41-87) | 59.0 (41-74) | 62 (51-77) | 61.5 (41-87) |
| Male (%) | 33.3 | 28.6 | 30.8 | 78.3 | 61.9 | 70.8 | 70.6 |
| Race (%) | |||||||
| White | 100.0 | 71.4 | 84.6 | 87.0 | 90.5 | 87.5 | 88.2 |
| Black | 0 | 14.3 | 7.7 | 8.7 | 0 | 12.5 | 7.4 |
| Asian | 0 | 14.3 | 7.7 | 0 | 9.5 | 0 | 2.9 |
| Lymphoma type, n (%) | |||||||
| DLBCL* | 2 (33.3) | 2 (28.6) | 4 (30.8) | 23 (100.0) | 0 | 0 | 23 (33.8) |
| FL | 2 (33.3) | 2 (28.6) | 4 (30.8) | 0 | 21 (100.0) | 0 | 21 (30.9) |
| MC | 2 (33.3) | 1 (14.3) | 3 (23.1) | 0 | 0 | 9 (37.5) | 9 (13.2) |
| CLL/SLL | 0 | 2 (28.6) | 2 (15.4) | 0 | 0 | 11 (45.8) | 11 (16.2) |
| MZL | 0 | 0 | 0 | 0 | 0 | 2 (8.3) | 2 (2.9) |
| MALT lymphoma | 0 | 0 | 0 | 0 | 0 | 1 (4.2) | 1 (1.5) |
| Other | 0 | 0 | 0 | 0 | 0 | 1 (4.2) | 1 (1.5) |
| Median months since diagnosis (range) | 69.0 (26-135) | 39.0 (17-207) | 63.0 (17-207) | 31.0 (5-216) | 78.0 (17-184) | 50.5 (7-137) | 49.0 (5-216) |
| Prior therapy | |||||||
| Median number (range) | 4.0 (1-7) | 4.0 (1-5) | 4.0 (1-7) | 4.0 (2-10) | 4.0 (1-11) | 2.5 (1-7) | 4.0 (1-11) |
| Prior rituximab, n | 6 | 7 | 13 | 22 | 21 | 22 | 65 |
| Rituximab within 6 mo, n | 1 | 2 | 3 | 9 | 4 | 4 | 17 |
| Prior autologous transplantation, n (%) | 0 | 2 (28.6) | 2 (15.4) | 12 (52.2) | 5 (23.8) | 2 (8.3) | 19 (27.9) |
| Prior radioimmunotherapy, n | 2 | 2 | 4 | 2 | 9 | 5 | 16 |
| Multiagent chemotherapy, n | 6 | 7 | 13 | 23 | 19 | 22 | 64 |
| Fludarabine-containing regimen, n | 1 | 3 | 4 | 1 | 7 | 7 | 15 |
MALT indicates mucosa-associated lymphoid tissue.
*
Nine patients had transformed DLBCL: 1 in cohort 1 of phase 1, 2 in cohort 2 of phase 1, and 6 in group 1 of phase 2.