Table 1. Summary of Prospective Clinical Trials Evaluating Role of Ibrutinib-Based Regimen in CLL.
| Trial | Regimen | Pts. (n) | Age (med) | Prior therapies (med) | Med f/u (M) | High risk factors n (%) | ORR (%) | CR (%) | PR (%) | PFS % (M) | OS % (M) | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| O’Brien et al [15] 2018 (5 year f/u) (1b/2) | Ibr | 31 | 71 | TN | 61.5 | Del17p | 6 | 87 | 29 | 92 (61) | 92 (61) | |
| Del11q | 3 | |||||||||||
| 67 | 64 | 4 | 61.5 | Del17p | 34 | 89 | 44 (61) | 60 (61) | ||||
| Del11q | 35 | |||||||||||
| Burger JA et al [21] 2014 (phase 2) | Ibr+ R | 40 | 63.2 | 2 | 16.8 | Del17p | 50 | 95 | 8 | 87 | 78 (18) | 84 (18) |
| Del11q | 32.5 | |||||||||||
| Byrd JC et al [13] 2014 (phase 3) | Ibr | 195 | 67 | 3 | 9.4 | Del17p | 32 | 63 | 0 | 63 | 88 (6) | 90 (12) |
| Del11q | 32 | |||||||||||
| Farooqui et al [16] 2014 (phase 2) | Ibr | 35 | 62 | TN | 15 | Del17p | 100 | 97 | 0 | 97 | 82 (24) | 84 (24) |
| Del11q | - | |||||||||||
| 16 | 62 | R/R | 26 | Del17p | 100 | 80 | 0 | 80 | 82 (24) | 74 (24) | ||
| Del11q | - | |||||||||||
| Burger JA et al [10] 2015 (phase 3) | Ibr | 136 | 73 | TN | 28.6 | Del17p | 0 | 92 | 18 | - | 89(24) | 95 (24) |
| Del11q | 21 | |||||||||||
| Brown, JR et al [23] 2015 (phase 1b) | Ibr + BR | 30 | 62 | 2 | 15.8 | Del17p | 23.3 | 96.7 | 40 | 56.7 | 86(12) | - |
| Del11q | 33.3 | |||||||||||
| Chanan-Khan et al [22] 2016 (phase 3) | Ibr + BR | 289 | 64 | 2 | 17 | Del17p | 0 | 83 | 10 | 73 | 79 (18) | - |
| Del11q | 30 | |||||||||||
| Susan O’brien et al [24] 2016 (phase 2) | Ibr | 145 | 64 | 2 | 11.5 | Del17p | 100 | 64 | 0 | 64 | 63 (24) | 75 (24) |
| Del11q | 16 | |||||||||||
| JP Sharman et al 2017 [25] (phase 3) | Ibr + Ubl | 64 | 67 | 3 | 12 | Del17p | 64 | 78 | 7 | 71 | - | - |
| Del11q | 36 | |||||||||||
| Ibr | 62 | Del17p | 66 | 45 | 0 | 45 | ||||||
| Del11q | 34 | |||||||||||
| Burger JA et al [20] 2017(phase 2) | Ibr | 102 | 65 | NR | 25.2 | Del17p | 37 | 98 | 21 | 77 | 91.2 (24) | - |
| Ibr + R | 104 | 65 | NR | 22.7 | Del11q | - | 100 | 28 | 72 | 90.4 (24) | - | |
| Jain N et al [17] 2017 (phase 2) | Ibr +FCG | 32 | NR | TN | 5.5 | Del17 | 0 | 100 | 46 | - | - | - |
| Davids MS et al [18] 2017 (phase 2) | Ibr + FCR | 49 | <65 | TN | 21 | Del17p | 9 | 100 | 63 | - | - | |
| Del11q | 26 | - | ||||||||||
| Rogers KA et al [19] 2017 (phase 1b2) | G + Ibr + V | 25 | NR | TN | NR | Del17p | 12 | 96 | 52 | - | - | - |
| Del11q | 20 | |||||||||||
Pts: patients; Ibr: ibrutinib; R: rituximab; BR: bendamustine + rituximab; Ubl: ublituximab; FCG: fludarabine + cyclophosphamide + obinutuzumab; FCR: fludarabine + cyclophosphamide + rituximab; G: obinutuzumab; V: venetoclax; TN: treatment naive; ORR: overall response rate; CR: complete response rate; PR: partial response rate; PFS: progression free survival; OS: overall survival; M: months; med: median.