Table 1.
Patient baseline characteristics
| Phase 1 dose escalation | Phase 2a dose expansion | All FL patients | |
|---|---|---|---|
| n | 32 | 42 | 57 |
| Median age at study entry (range), y | 69.0 (38-88) | 68.0 (51-80) | 69.0 (38-80) |
| ≥65 y, n (%) | 24 (75.0) | 30 (71.4) | 41 (71.9) |
| Male, n (%) | 23 (71.9) | 18 (42.9) | 32 (56.1) |
| NHL subtype, n (%) | |||
| FL grade I | 10 (31.3) | 5 (11.9) | 15 (26.3) |
| FL grade II | 18 (56.3) | 15 (35.7) | 33 (57.9) |
| FL grade IIIa | 0 (0) | 9 (21.4) | 9 (15.8) |
| MZL | 1 (3.1) | 8 (19.0) | — |
| SLL | 0 (0) | 1 (2.4) | — |
| MCL | 3 (9.4) | 4 (9.5) | — |
| Bulky disease (>6 cm), n (%) | 10 (31.3) | 17 (40.5) | 22 (38.6) |
| BM involvement, n (%) | 7 (21.9) | 9 (21.4) | 11 (19.3) |
| Prior therapies | |||
| Median prior treatments, n (range) | 3 (1-6) | 2 (1-8) | 2 (1-7) |
| ≥2 prior regimens, n (%) | 23 (71.9) | 26 (61.9) | 38 (66.7) |
| Prior bendamustine, n (%) | 13 (40.6) | 10 (23.8) | 15 (26.3) |
| Refractory (SD or PD) to last therapy, n (%) | 9 (28.1) | 12 (28.6) | 17 (29.8) |
| Rituximab refractory, n (%) | 12 (37.5) | 19 (45.2) | 26 (45.6) |
BM, bone marrow; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; PD, progressive disease; SD, stable disease; SLL, small lymphocytic lymphoma.