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


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.

SUBMITTER: Nowakowski GS 

PROVIDER: S-EPMC5551933 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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

Nowakowski Grzegorz S GS   Chiappella Annalisa A   Witzig Thomas E TE   Spina Michele M   Gascoyne Randy D RD   Zhang Lei L   Flament Jocelyne J   Repici Jacqueline J   Vitolo Umberto U  

Future oncology (London, England) 20160418 13


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) plu  ...[more]

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