Table 2.
Phase III trials with ibrutinib.
| Disease | Trial | Eligibility | Regimen |
|---|---|---|---|
| DLBCL (non-GCB) | NCT01855750 | Newly diagnosed | Ibrutinib + R-CHOP versus placebo + R-CHOP |
| Indolent NHL | NCT01974440 | R/R, ≥1 prior therapy | (R-CHOP or BR) + ibrutinib versus (R-CHOP or BR) + placebo |
| MCL | NCT01776840 (SHINE) | Untreated ≥ 65 years old | BR + ibrutinib versus BR + placebo |
| NCT01646021 (RAY) | R/R, ≥1 prior therapy | Ibrutinib versus temsirolimus | |
| CLL | NCT01578707 (RESONATE) | R/R not eligible for purine analogues | Ibrutinib versus ofatumumab |
| NCT01722487 (RESONATE 2) | Untreated ≥ 65 years old | Ibrutinib versus chlorambucil | |
| NCT01611090 (HELIOS) | R/R, ≥1 prior therapy | BR + ibrutinib versus BR + placebo | |
| NCT01886872 | Untreated ≥ 65 years old | BR versus ibrutinib versus ibrutinib + rituximab | |
| NCT01973387 | R/R Chinese adults | Ibrutinib versus rituximab | |
| US Intergroup ECOG 1912 (Protocol in development) | Untreated fit patients | Ibrutinib-based therapy versus fludarabine + cyclophosphamide + rituximab | |
| UK NCRI CLL10 | Untreated fit patients | Ibrutinib + rituximab versus fludarabine + cyclophosphamide + rituximab |
BR, bendamustine rituximab; CLL, chronic lymphocytic leukemia; GCB-DLBCL, nongerminal center B-cell diffuse large B-cell lymphoma; MCL, mantle cell lymphoma; NHL, non-Hodgkin’s lymphoma; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R/R, relapsed/refractory.