Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma*

被引：9

作者：

Wilson, Wyndham H. ^{[1
]}

Phillips, Tycel ^{[2
]}

Popplewell, Leslie ^{[3
]}

de Vos, Sven ^{[4
]}

Chhabra, Saurabh ^{[5
]}

Kimball, Amy S. ^{[6
]}

Beaupre, Darrin ^{[7
]}

Huang, Da Wei ^{[1
]}

Wright, George ^{[1
]}

Kwei, Kevin ^{[8
]}

Ping, Jerry ^{[9
]}

Neuenburg, Jutta K. ^{[10
]}

Staudt, Louis M. ^{[11
]}

机构：

[1] NCI, Lymphoma Therapeut Sect, 9609 Med Ctr Dr, Bethesda, MD 20892 USA

[2] Univ Michigan, Div Hematol & Oncol, Ann Arbor, MI 48109 USA

[3] City Hope Natl Med Ctr, Dept Hematol & Hematopoiet Cell Transplant, 1500 E Duarte Rd, Duarte, CA 91010 USA

[4] Univ Calif Los Angeles, David Geffen Sch Med, Dept Med, Los Angeles, CA 90095 USA

[5] Med Coll Wisconsin, Dept Med, Milwaukee, WI 53226 USA

[6] Univ Maryland, Sch Med, Baltimore, MD 21201 USA

[7] Pharmacyclics LLC, Early Dev & Immunotherapy, Sunnyvale, CA USA

[8] Pharmacyclics LLC, Dept Translat Med, Sunnyvale, CA USA

[9] Pharmacyclics LLC, Dept Stat, Sunnyvale, CA USA

[10] Pharmacyclics LLC, Dept Oncol, Sunnyvale, CA USA

[11] NCI, Lymphoid Malignancies Branch, Bethesda, MD 20892 USA

来源：

LEUKEMIA & LYMPHOMA | 2021年 / 62卷 / 09期

关键词：

Ibrutinib; lenalidomide; dose-adjusted EPOCH-R; diffuse large B-cell lymphoma; activated B-cell-like; germinal center B-cell-like; GERMINAL CENTER; RITUXIMAB; CHEMOTHERAPY; TRIAL; COMBINATION; THERAPY; CHOP;

D O I：

10.1080/10428194.2021.1907371

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：2094 / 2106

页数：13

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