Leukemia & lymphoma · 2021
Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Wilson Wyndham H, Phillips Tycel, Popplewell Leslie, de Vos Sven, Chhabra Saurabh, Kimball Amy S, Beaupre Darrin, Huang Da Wei, Wright George, Kwei Kevin, Ping Jerry, Neuenburg Jutta K, Staudt Louis M
Аннотация
Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) is difficult to cure; non-germinal center B-cell-like (non-GCB) and activated B-cell-like (ABC) DLBCL have worse outcomes than GCB DLBCL. Ibrutinib and lenalidomide are synergistic in vitro in ABC DLBCL and may augment salvage chemotherapy. In part 1 of this phase 1b/2 study (NCT02142049), patients with relapsed/refractory DLBCL received ibrutinib 560 mg and escalating doses of lenalidomide on Days 1-7 with DA-EPOCH-R (Days 1-5) in 21-day cycles. In part 1 (N = 15), the maximum tolerated dose was not reached with lenalidomide 25 mg (recommended part 2 dose [RP2D]); most common grade ≥3 adverse events were anemia (73%) and febrile neutropenia (47%); the overall response rate (ORR) was 40%. At the RP2D (n = 26), ORR was 71% in non-GCB and 64% in ABC. Ibrutinib and lenalidomide with DA-EPOCH-R had a manageable safety profile and antitumor activity in relapsed/refractory DLBCL, especially the non-GCB subtype.