Table 1.
Clinical trials in previously untreated patients
| Authors | Schedule | Patient number | ORR (%) (CRR %) | Follow-up (mo) | PFS (mo) | OS (mo) |
|---|---|---|---|---|---|---|
| Flinn et al 201249 | O: 300 mg D1; 2,000 mg D8; 2,000 mg weekly for 6 w; 2,000 mg monthly for 4 mo | 42 | 44 (0) | NR | NR | NR |
| Ciccone et al 201450 | O: 300 mg D1; 2,000 mg D8; D15; D22 (C1); 2,000 mg monthly for 12 mo (O: 1,000 mg for the first 8 patients) |
13 | 69 (23) | 24 | 46% | 92% |
| Jain et al 201351 | O: 300 mg D1, 1,000 mg weekly for 7 w | 18 | 67 (17) | 7.6 | 83% | 100% |
| Ma et al 201452 | Alem 3 times/w up to 18 w O: (from w3): 300 mg D1; 2,000 mg q2 w doses week 2 to week 8 (early interruption based on response assessment) |
31 | 97 (42) | NR | 90% | 94% |
| Wierda et al 201153 | F: 25 mg/m2 D2–4 C: 250 mg/m2 D2–4 + O: 300 mg D1C1 → 500 mg D1C2–6 vs O: 300 mg D1C1 → 1,000 mg D1C2–6 q28 × 6 cycles |
31 vs 30 | 77 (32) vs 73 (50) | 8 | nr | nr |
| Shanafelt et al 201354 | P: 2 mg/m2 C: 600 mg/m2 O: C1 300 mg D1; 1,000 mg D8 C2–6 1,000 mg D1 q21 × 6 cycles |
48 | 96 (46) | 24 (living patients) | nr (TTR) | 42 patients alive at 24 months |
| Montillo et al 201555 | P: 2mg/m2 C: 600 mg/m2 O: C1 300 mg D1; 1,000 mg D8 C2–6 1,000 mg D1 q21 × 6 cycles |
47 | 89 (51) | 22 | nr | nr |
| Hillman et al 201556 | Chl: 10 mg/m2 D1–7 q 28 up to 12 cycles vs O: C1 300 mg D1; 1,000 mg D8 C2–6 1,000 mg D1 + Chl: 10 mg/m2 D1–7 q28 up to 12 cycles |
226 vs 221 | 69 (1) vs 82 (14) | 29 | 13 vs 22 | nr nr |
| Offner et al 201438 | O: 300 mg C1D1, 1,000 mg C1D8; 1,000 mg D1C2 to C6 B: 90 mg/m2 D1–2 C1 → 6 |
44 | 95 (48) | 8.5 | NR | NR |
Abbreviations: O, ofatumumab; Alem, alemtuzumab; F, fludarabine; C, cyclophosphamide; P, pentostatin; Chl, chlorambucil; B, bendamustine; ORR, overall response rate; CR, complete response; CRR, complete remission rate; PFS, progression free survival; OS, overall survival; mo, month(s); NR, not reported; nr, not reached; D, day; w, week(s); TTR, time to retreatment; C, cycle.