Table I.
Patient and disease characteristics at baseline.
| Characteristic | Cohort 6 (n = 40) |
|---|---|
| Age | |
| Median (range), years | 64·5 (37–85) |
| ≥65 years, n (%) | 20 (50) |
| Male sex, n (%) | 23 (58) |
| ECOG performance status score of 1, n (%) | 22 (55) |
| Disease stage, n (%) | |
| I or II | 14 (35) |
| III or IV | 26 (65) |
| IPI score, n (%) | |
| 0–2 | 22 (55) |
| 3–4 | 18 (45) |
| Number of prior lines of chemotherapy, n % | |
| 1 | 2 (5) |
| 2 | 23 (58) |
| 3 | 12 (30) |
| 4 | 2 (5) |
| ≥5 | 1 (3) |
| Prior autologous SCT, n (%) | 10 (25) |
| PD as best response to most recent chemotherapy, n (%)* | 17 (43) |
| Median (range) tumour burden by SPD,† mm2 | 1 184 (116–17 057) |
| Median (range) LDH, U/l | 236 (155–2 042) |
| Median (range) ferritin, ng/ml | 364 (13–1 748) |
| Refractory subgroup, n (%) | |
| Primary refractory | 2 (5) |
| Refractory ≥ second‐line therapy | 23 (58) |
| Relapsed ≥ second‐line therapy | 7 (18) |
| Relapsed post‐ASCT | 8 (20) |
ASCT, autologous stem cell transplant; ECOG, Eastern Cooperative Oncology Group; IPI, International Prognostic Index; LDH, lactate dehydrogenase; PD, progressive disease; SCT, stem cell transplant; SPD, sum of the products of diameters.
*
For patients who had not relapsed post‐ASCT.
†
Restaged after bridging, except for two patients without post‐bridging assessment in which case the screening assessments were used for baseline.