Table 3.
Combination clinical trials with ibrutinib in NHL
| Study drugs (clinical trials # for ongoing studies) | Phase 1, 2, or 3 (Number of patients) | Patient population (median age) | OR | Median PFS | Reference |
|---|---|---|---|---|---|
| Monoclonal antibody combinations | |||||
| R-ibrutinib | Phase 2 (50) | R/R MCL | 87% (38% CR) | NA | Wang30 |
| R-ibrutinib (NCT01980654) | Phase 2 (80) | Front-line FL | Ongoing | Ongoing | |
| R-ibrutinib vs. R-placebo (NCT02165397) | Phase 3 (180) | Front-line WM | Ongoing | Ongoing | |
| Cytotoxic chemotherapy combinations | |||||
| R-bendamustine & ibrutinib | Phase 1/1b (48) | Relapsed NHL and front-line MCL (62) | ALL NHL: 72% (76% CR) MCL: 94% (76% CR) DLBCL:3 7% (31% CR) FL: 90% (50% CR) |
Not reached, 2-year PFS 50.3% | Maddocks29 |
| R-bendamustine & ibrutinib vs. R-bendamustine & placebo (NCT01776840) | Phase 3 (520) | Front-line MCL (≥ 65) | Ongoing | Ongoing | |
| RCHOP & ibrutinib | Phase 1b (33) | R/R NHL (60.5) | ALL NHL: 91% (70% CR) DLBCL: 95% |
NA | Younes15 |
| RCHOP & ibrutinib vs. RCHOP & placebo (NCT01855750) | Phase 3 (800) | Front-line DLBCL | Ongoing | Ongoing | |
| RCHOP or R-bendamustine & ibrutinib vs. RCHOP or R-bendamustine & placebo (NCT01974440) | Phase 3 (400) | R/R FL or MZL | Ongoing | Ongoing | |
| DA-REPOCH, ibrutinib & lenalidomide (NCT02142049) | Phase 1 (56) | R/R DLBCL | Ongoing | Ongoing | |
| RICE & ibrutinib (NCT02219737) | Phase 1 (20) | R/R DLBCL | Ongoing | Ongoing | |
| RDHAP & ibrutinib (NCT02055924) | Phase 1 (60) | R/R NHL | Ongoing | Ongoing | |
| Immunomodulatory and other agent combinations | |||||
| Lenalidomide & ibrutinib (NCT01955499) | Phase 1 (34) | R/R NHL (68) | Ongoing | Ongoing | Christian34 |
| R, Lenalidomide, & ibrutinib (NCT02077166) | Phase 1b/2 (120) | R/R DLBCL | Ongoing | Ongoing | |
| R, Lenalidomide and ibrutinib (NCT01829568) | Phase 1 (33) | Front-line FL | Ongoing | Ongoing | |
| Ublituximab, TGR-1201 (PI3K δ inhibitor), & ibrutinib (NCT02006485) | Phase 1 (80) | R/R NHL | Ongoing | Ongoing | |
| ABT-199 & ibrutinib (NCT02419560) | Phase 1 (28) | R/R MCL | Ongoing | Ongoing | |
Abbreviations: OR: Overall response; PFS: Progression-free survival; R/R: relapsed/refractory; MCL: Mantle cell lymphoma; CR: complete response; FL: follicular lymphoma; WM: Waldenstrom's macroglobulinemia; NHL: non-Hodgkin's lymphoma; DLBCL: diffuse large B-cell lymphoma; RCHOP: rituximab, cyclophosphamide, adriamycin, vincristine, prednisone; DA-REPOCH: dose adjusted rituximab, etoposide, prednisone, vincristine, cyclophosphamide, adriamycin; RICE: rituximab, ifosfamide, cisplatin, etoposide; RDHAP: rituximab, dexamethasone, cytarabine, cisplatin.