Table 2.
Clinical trials in relapsed/refractory patients
| Authors | Schedule | Patient number | ORR (%) (CRR %) | Follow-up (mo) | PFS (mo) | OS (mo) |
|---|---|---|---|---|---|---|
| Coiffier et al 200833 | O: 100 mg → 500 mg | 3 | 33 | NR | 2.6 | NR |
| O: 300 mg → 1,000 mg | 3 | 0 | 2.5 | |||
| O: 500 mg → 2,000 mg | 27 | 50 | 4.4 | |||
| For 4 infusions | ||||||
| Wierda et al 201034 | O: 300 mg D1; D8; 2,000 mg weekly for 6 w; 2,000 mg monthly for 4 mo FA-ref BF-ref |
59 79 |
57 48 |
NR | 5.7 5.9 |
13.7 15.4 |
| Cortelezzi et al 201437 | O: 300 mg C1D1, 1,000 mg C1D8; 1,000 mg D1C2 → 6 B: 70 mg/m2 D1–2 C1 to C6 |
47 | 72 (17) | 24.2 | 49.6% | 83.6% |
| Offner et al 201438 | O: 300 mg C1D1, 1,000 mg C1D8; 1,000 mg D1C2 → 6 B: 70 mg/m2 D1–2 C1 → 6 |
53 | 74 (11) | 8.7 | nr | nr |
| Castro et al 201440 | O: 300 mg D1; 1,000 mg weekly for 12 w mPDN 1,000 mg/m2 D1–3 q28 |
21 | 81 (5) | 31 | 9.9 | nr |
| Doubek et al 201541 | O: C1D1: 300 mg, D8, 15, 22: 2,000 mg; C2–6 D1, 8, 15, 22: 1,000 mg Dexa D1 → 4; 15 → 18 C1 → C6 |
33 | 67 (15) | NR | 11 | 34 |
| Costa et al 201543 | O: C1 → 6 2,000 mg D1 lenalidomide 10 mg D8 → 28 q28 for 6 C |
21 | 47.6 | 16.1 | nr | 21.5 |
| Byrd et al 201464 | O: 300 mg D1; 2,000 mg D8; 2,000 mg weekly for 6 w; 2,000 mg monthly for 4 mo vs ibrutinib 420 mg daily |
196 vs 195 | 4 (0) vs 43 (0) | 9.4 | 8.1 mo vs nr | nr in both (at 12 mo 81 vs 90%) |
| Jaglowski et al 201565 | O: 300 mg w5; 2,000 mg w6; 2,000 mg weekly for 6 w; 2,000 mg monthly for 4 mo + ibrutinib 420 mg daily from D1 O: starting from w1 D2 + ibrutinib 420 mg daily from w1 D1 O: starting from w1 D1 + ibrutinib 420 mg daily from w9 |
27 20 24 |
100 79 71 |
12.5 | nr (at 12 mo 88.7%) nr (at 12 mo 85%) nr (at 12 mo 75%) |
nr (at 12 mo 92.3%) nr (at 12 mo 85%) nr (at 12 mo 87.5) |
| Moreno et al 201544 | Observational | 103 | 22 (3) | 9.4 | 5 | 11 |
| Chowdhury et al 201145 | Observational | 27 | 48 (11) | 8 | 5.5 (TTNT) | nr |
| Dupuis et al 201546 | Observational | 30 | 47 (13) | 8 | 4.3 | 8.3 |
Abbreviations: O, ofatumumab; B, bendamustine; Dexa, dexamethasone; mPDN, methylprednisolone; FA-ref, fludarabine refractory; BF-ref, bulky-fludarabine refractory; 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); C, cycle; TTNT, time to next treatment.