Table 1.
Trial details and patient characteristics.
| Trial Name NCT Number | First Author Published Year | Trial Design | Experimental Arm | Control Arm | Mean Age | Rai Stage > III (%) | Number of Prior Therapies | Del(17p) Mutation (%) |
|---|---|---|---|---|---|---|---|---|
| Study 119 (NCT01659021) | Jones, J.A. 2017 | OP, RCT Phase III | Idelalisib Ofatumumab a (Ide: 150 mg bid po) | Ofatumumab b | 67.7 | 63.70% | 3 vs. 3 | 40% vs. 38% |
| DUO trial (NCT02004522) | Flinn, I.W. 2018 | OP, RCT Phase III | Duvelisib (25 mg bid po) | Ofatumumab b | 69 | 56% | 2 vs. 2 | 21% vs. 28% |
| RESONATE (NCT01578707) | Brown, J.R. 2018 | OP, RCT Phase III | Ibrutinib (420 mg qd po) | Ofatumumab b | 66.8 | 57.30% | 3 vs. 2 | 32% vs. 33% |
| CR102604 (NCT01973387) | Huang, X. 2018 | OP, RCT Phase III | Ibrutinib (420 mg qd po) | Rituximab c | 63.6 | 77.70% | 2 vs. 2 | 27.1% vs. 24.1% |
| HELIOS (NCT01611090) | Chanan-Khan, A. 2016 | DB, RCT Phase III | Ibrutinib BR d (Ibr 420 mg qd po) | BR d | 63.5 | 42.50% | 2 vs. 2 | 0% vs. 0% |
| MURANO (NCT02005471) | Seymour, J.F. 2018 | OP, RCT Phase III | Venetoclax R e | BR d | 65.3 | 18% | 2 vs. 2 | 23.7% vs. 23.6% |
| TUGELA (NCT01569295) | Zelenetz, A.D. 2017 | DB, RCT Phase III | Idelalisib BR d (Ide.: 150 mg bid po) | BR d | 63 | 45.50% | 2 vs. 2 | 18% vs. 19% |
DB: Double blind, OP: Open label, RCT: Randomized control trial, B: Bendamustine, R: Rituximab, Ide: Idelalisib, Ibr: Ibrutinib. a Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for seven weeks, and then 1000 mg every four weeks for four doses). b Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for seven weeks, and then 2000 mg every four weeks for four doses). c Rituximab: Up to six cycles (total of eight doses administered by intravenous infusion) 375 mg/m2 on Day 1 of Cycle 1, 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1–4), 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5–8), and 500 mg/m2 on Day 1 of Cycles 3–6 (Weeks 9–24). d Bendamustine 70 mg/mg2/day on two consecutive days every 28 days administered intravenously for a maximum of 12 infusions. Rituximab 375 mg/m2 on Day 1, then 500 mg/m2 every 28 days administered intravenously for a maximum of six infusions. e Venetoclax was administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a five-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or two years. Rituximab 375 mg/m2 on Day 1, then 500 mg/m2 every 28 days administered intravenously for a maximum of six infusions.