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Clinical Trial
. 2016 Jul;12(13):1553-63.
doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18.

ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma

Grzegorz S Nowakowski  1 , Annalisa Chiappella  2 , Thomas E Witzig  1 , Michele Spina  3 , Randy D Gascoyne  4 , Lei Zhang  5 , Jocelyne Flament  5 , Jacqueline Repici  5 , Umberto Vitolo  2
Affiliations
Clinical Trial

ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma

Grzegorz S Nowakowski et al. Future Oncol. 2016 Jul.

Abstract

Activated B-cell-like (ABC) diffuse large B-cell lymphoma (DLBCL), the major constituent of nongerminal center B-cell-like (non-GCB) DLBCL, is associated with poorer survival outcomes than GCB-type DLBCL. In Phase II studies, lenalidomide combined with R-CHOP (R(2)-CHOP) improved outcomes relative to historical R-CHOP in newly diagnosed DLBCL, particularly in non-GCB cases. ROBUST (CC-5013-DLC-002) is a randomized, double-blind, global, Phase III study of oral lenalidomide (15 mg, days 1-14) plus R-CHOP21 × 6 versus placebo-R-CHOP21 × 6 in patients with previously untreated ABC-type DLBCL. Subtyping is done within 3 calendar days by central laboratory gene-expression profiling of formalin-fixed paraffin-embedded biopsy tissue. The primary end point is progression-free survival. Secondary end points include response rates, overall survival and health-related quality of life.

Keywords: chemotherapy; hematologic/lymphoma; molecular oncology.

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Conflict of interest statement

Financial & competing interests disclosure

G Nowakowski received research funding and travel expenses from and has a consulting/advisory role at Celgene. A Chiappella has participated in speaker's bureaus from Celgene, Roche, Pfizer, Janssen and Teva. T Witzig received research funding from Celgene. M Spina received honoraria from Teva, Servier, Janssen-Cilag, Gilead, Roche, Mundipharma and Menarini, has had consulting or advisory roles with Teva, Gilead, Takeda, Janssen and Menarini, has received research funding from Mundipharma, Teva and Menarini, and has received travel expenses from Janssen, Servier, Teva, Menarini, Mundipharma, Gilead, Roche and Takeda. RD Gascoyne receives consulting fees from Celgene, AbbVie and Seattle Genetics, honoraria from Celgene, AbbVie and Seattle Genetics, and has participated in a Seattle Genetics speaker's bureau. L Zhang, J Flament, and J Repici are employed by Celgene and report Celgene stock ownership. U Vitolo received research funding from Celgene and Roche, has had consulting or advisory roles at Roche and Janssen, and has participated in speaker's bureaus from Roche, Celgene and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

This study is supported by Celgene Corporation, Summit, NJ, USA. Medical writing support was provided by Robert Rydzewski MS, CMPP, of Bio Connections LLC, funded by Celgene Corporation.

Figures

<b>Figure 1.</b>
Figure 1.. NanoString gene-expression profiling using the Lymph2Cx assay.
DLBCL: Diffuse large B-cell lymphoma; GCB: Germinal center B cell; IHC: Immunohistochemistry. Republished with permission from [18] © Clearance Center, Inc.
<b>Figure 2.</b>
Figure 2.. Progression-free survival by cell-of-origin in the Fondazione Italiana Linfomi REAL07 study.
GCB: Germinal center B cell. Reprinted with permission from [34] © Elsevier (2014).
<b>Figure 3.</b>
Figure 3.. ROBUST study design.
†Option for two additional rituximab doses after completing treatmentregimen (if considered standard of care per local practice), and optionfor pre-specified local radiotherapy for bulky disease after study chemotherapy. ABC: Activated B cell; DLBCL: Diffuse large B-cell lymphoma; GCB: Germinal center B cell; GEP: Gene-expression profiling; R-CHOP: Rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone.
<b>Figure 4.</b>
Figure 4.. ROBUST participating countries as of February 2016.
PAC: Pacific.
See this image and copyright information in PMC

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