Table 1.
Demographics and baseline characteristics
| Characteristic | Phase 1 (n = 4) | Phase 2 (n = 44) | Total (n = 48) |
|---|---|---|---|
| Age, years, median (range) | 72.5 (42–76) | 69.0 (32–79) | 69.5 (32–79) |
| Sex, n (%) | |||
| Male | 1 (25) | 30 (68) | 31 (65) |
| Female | 3 (75) | 14 (32) | 17 (35) |
| ECOG PS, n (%) | |||
| 0 | 2 (50) | 27 (61) | 29 (60) |
| 1 | 2 (50) | 17 (39) | 19 (40) |
| Disease classification, n (%) | |||
| Peripheral T cell lymphoma, NOS | 1 (25) | 21 (48) | 22 (46) |
| Angioimmunoblastic T cell lymphoma | 2 (50) | 17 (39) | 19 (40) |
| Anaplastic large cell lymphoma | |||
| ALK-positive | 1 (25) | 0 (0) | 1 (2) |
| ALK-negative | 0 (0) | 2 (5) | 2 (4) |
| Extranodal T cell/NK cell lymphoma, nasal type | 0 (0) | 1 (2) | 1 (2) |
| Transformed mycosis fungoides | 0 (0) | 1 (2) | 1 (2) |
| Othera | 0 (0) | 2 (5) | 2 (4) |
| Ann Arbor classification,bn (%) | |||
| Stage I | 0 (0) | 1 (2) | 1 (2) |
| Stage II | 3 (75) | 9 (20) | 12 (25) |
| Stage III | 0 (0) | 20 (45) | 20 (42) |
| Stage IV | 1 (25) | 13 (30) | 14 (29) |
| LDH (baseline) | |||
| Low/normal | 2(50.0) | 24 (55) | 26 (54) |
| High | 2(50.0) | 20 (45) | 22(46) |
| Prior treatment regimens | |||
| Median (range) | 2 (1–9) | 2 (1–6) | 2 (1–9) |
| Chemotherapy, n (%) | 4 (100) | 44 (100) | 48 (100) |
| ASCT, n (%) | 0 (0) | 3 (7) | 3 (6) |
| Radiation therapy, n (%) | 1 (25) | 5 (11) | 6 (13) |
| Monoclonal antibody, n (%) | 1 (25) | 3 (7) | 4 (8) |
| Corticosteroid, n (%) | 1 (25) | 2 (5) | 3 (6) |
| Response to most recent treatment regimen, n (%) | |||
| CR/CRu | 3 (75) | 20 (45) | 23 (48) |
| PR | 1 (25) | 24 (55) | 25 (52) |
ALK anaplastic lymphoma kinase, ASCT autologous hematopoietic stem cell transplant, CR complete response, CRu unconfirmed complete response, ECOG PS Eastern Cooperative Oncology Group performance status, LDH lactate dehydrogenase, NK cell natural killer cell, NOS not otherwise specified, PR partial response, SD standard deviation
aIncludes two cases judged to be plasmablastic lymphoma and follicular dendritic cell sarcoma, respectively, on the independent central pathology review
bClassification for PTCLs other than transformed mycosis fungiodes. The case of transformed mycosis fungiodes was stage IV by the ISCL-EORTC classification