Table 1.
Baseline characteristics of the patients and prior therapy
| Characteristic | Phase I (N = 20) | Phase II (N = 15) | Patients (N = 35) |
|---|---|---|---|
| Median age – years (range) | 65·5 (50–88) | 69 (45–86) | 66 (45–88) |
| Gender – n (%) | |||
| Female | 8 (40) | 10 (67) | 18 (51) |
| Male | 12 (60) | 5 (33) | 17 (49) |
| ECOG – n (%) | |||
| 0 | 9 (45) | 4 (27) | 13 (37) |
| 1 | 10 (50) | 10 (67) | 20 (57) |
| 2 | 1 (5) | 1 (6) | 2 (6) |
| Subtype of lymphoma – n (%) | |||
| Indolent NHL | 10 (50) | 10 (67) | 20 (57) |
| Follicular | 7 (35) | 5 (33) | 12 (29) |
| Marginal zone | 3 (15) | 5 (33) | 8 (23) |
| CLL/SLL | 8 (40) | – | 8 (23) |
| Aggressive NHL | 2 (10) | 5 (33) | 7 (20) |
| Mantle Cell | 2 (10) | 3 (20) | 5 (14) |
| Diffuse Large B‐Cell | – | 2 (13) | 2 (6) |
| Prior therapy regimens – median (range) | 3·5 (1–6) | 2 (1–9) | 3 (1–9) |
| Prior therapy – n (%) | |||
| Rituximab | – | – | 35 (100) |
| Alkylating Agent (R‐CHOP, R‐CVP, R‐ICE, other) | – | – | 23 (66) |
| Bendamustine (± rituximab) | – | – | 12 (34) |
| Purine analogue | – | – | 10 (29) |
| Stem‐cell transplantation | – | – | 5 (14) |
| Bortezomib | – | – | 5 (14) |
| Experimental therapya | – | – | 6 (17) |
| Rituximab‐refractory – n (%) | 7 (35) | 8 (53) | 15 (43) |
| 2 or > prior rituximab regimens – n (%) | 14 (70) | 11 (73) | 25 (71) |
| Refractory to immediate prior therapy – n (%) | 7 (35) | 8 (53) | 15 (43) |
CLL, chronic lymphocytic leukaemia; ECOG, Eastern Cooperative Oncology Group; NHL, non‐Hodgkin lymphoma; R‐CHOP, rituximab, cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine) and prednisone; R‐CVP, rituximab, cyclophosphamide, vincristine and prednisone; R‐ICE, rituximab, ifosfamide, carboplatin and etoposide; SLL, small lymphocytic lymphoma.
a
Includes bevacizumab, vorinostat, MLN4924, brentuximab, pralatrexate, lenalidomide.