Table 1.
Baseline demographic and clinical characteristics.
| Variable |
Arm 1 (n = 60) |
Arm 2 (n = 20) |
|---|---|---|
| Age, years | ||
| Median (range) | 58 (32–84) | 55 (30–75) |
| ≥65, n (%) | 18 (30) | 8 (40) |
| Male sex, n (%) | 28 (47) | 12 (60) |
| Cytopenia at baseline, n (%) | ||
| ANC ≤1·5 × 109/L | 2 (3) | 0 (0) |
| Haemoglobin ≤110 g/l | 5 (8) | 0 (0) |
| Platelets ≤100 × 109/l | 2 (3) | 0 (0) |
| Disease Grade, n (%) | ||
| 1 | 19 (32) | 11 (55) |
| 2 | 35 (58) | 8 (40) |
| 3a | 6 (10) | 1 (5) |
| Disease Stage, n (%) | ||
| II | 12 (20) | 1 (5) |
| III | 24 (40) | 8 (40) |
| IV | 24 (40) | 11 (55) |
| ECOG Performance Status, n (%) | ||
| 0 | 47 (78) | 12 (60) |
| 1 | 13 (22) | 8 (40) |
| ≥2 | 0 | 0 |
| FLIPI score, n (%) | ||
| Low risk (0–1) | 7 (12) | 1 (5) |
| Intermediate risk (2) | 23 (38) | 9 (45) |
| High risk (3–5) | 30 (50) | 10 (50) |
| Time from first FL diagnosis to first study dose, months, median (range) | 3·1 (0·1–178·5) | 2·6 (0·2–57·5) |
| Target lesion SPD, cm2, median (range) | 23·7 (2·9–135·5) | 15·7 (3·0–161·0) |
| Bulky disease, n (%) | ||
| ≥5 cm in ≥1 site | 23 (38) | 3 (15) |
| ≥7 cm in ≥1 site | 12 (20) | 1 (5) |
| ≥10 cm in ≥1 site | 2 (3) | 1 (5) |
ANC, absolute neutrophil count; ECOG, Eastern Cooperative Oncology Group; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; SPD, sum of the product of diameters.