TABLE 1.
Characteristics of studies included in meta-analysis.
| Study | Clinic trials gov | Disease | Age(y), median (range) | Study arms | No. of patients (ibrutinib vs. placebo arm) | Ibrutinib daily dose (mg) | Median follow up (mo) | Over all bleeding incidence (ibrutinib/control) | Major bleeding incidence (ibrutinib/control) |
|---|---|---|---|---|---|---|---|---|---|
| Byrd (Byrd et al., 2014) | NCT01578707 | RR CLL/SLL | 67 (30–88) | Ibrutinib vs. Ofatumumab | 391 (195 vs. 196) | 420 | 9.4 | 86/24 | 2/3 |
| Burger (Burger et al., 2015) | NCT01722487 | Untreated CLL/SLL | 73 (65–89) | Ibrutinib vs. Chlorambucil | 267 (135 vs. 132) | 420 | 18.4 | N/R | 6/3 |
| Chanan-Khan (Chanan-Khan et al., 2016) | NCT01611090 | RR CLL/SLL | 64 (31–86) | Ibrutinib + Bendamustine + Rituximab vs. placebo + Bendamustine + Rituximab | 574 (287 vs. 287) | 420 | 17 | 89/42 | 11/5 |
| Dreyling (Dreyling et al., 2016; Cramer et al., 2018) | NCT01646021 | RR MCL | 68 (IQR 13) | Ibrutinib vs. Temsirolimus | 278 (139 vs. 139) | 560 | 38.7 | 56/46 | 13/7 |
| Dimopoulos (Dimopoulos et al., 2018) | NCT02165397 | WM | 69 (36–89) | Ibrutinib + Rituximab vs. Placebo + Rituximab | 150 (75 vs. 75) | 420 | 26.5 | 38/16 | 3/3 |
| Huang (Huang et al., 2018) | NCT01973387 | RR CLL/SLL | 66 (21–87) | Ibrutinib vs. Rituximab | 156 (104 vs. 52) | 420 | 17.8 | 30/2 | 3/1 |
| Woyach (Woyach et al., 2018) | NCT01886872 | Untreated CLL | 71 (65–89) | Ibrutinib vs. Ibrutinib + Rituximab vs. Bendamustine + Rituximab | 537 (176 vs. 180 vs. 181) | 420 | 38 | N/R | 8/0 |
| Moreno (Moreno et al., 2019) | NCT02264574 | Untreated CLL/SLL | 71 (66–76) | Ibrutinib + Obinutuzumab vs. chlorambucil + Obinutuzumab | 228 (113 vs. 115) | 420 | 31.3 | 10/0 | 4/0 |
| Shanafelt (Shanafelt et al., 2019) | NCT02048813 | Untreated CLL/SLL | 56.7 (49.3–64.1) | Ibrutinib + Rituximab vs. Fludarabine + Cyclophosphamide + Rituximab | 510 (352 vs. 158) | 420 | 33.6 | N/R | 4/0 |
| (Deeks, 2017) | NCT01855750 | Untreated DLBCL | 62 (19–88) | Ibrutinib + R-CHOP vs. Placebo + R-CHOP | 834 (416 vs. 418) | 560 | 34.8 | N/R | 11/6 |
| Langerbeins (Langerbeins et al., 2019) | NCT02863718 | Untreated CLL | — | Ibrutinib vs. Placebo | 363 (185 vs. 178) | 420 | 31 | 51/17 | 6/2 |
N/R, not report; CTCAE, common terminology criteria for adverse events; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; AE, adverse events; RR, relapse/refractory; CLL/SLL, chronic lymphocytic leukemia/Small lymphocytic leukemia; MCL, mantle-cell lymphoma; WM, waldenstrom macroglobulinemia; DLBCL, diffuse large B-cell lymphoma.