Phase 2/3 study of Lenalidomide in Diffuse Large B-Cell Lymphoma

• Research type

  Research Study

• Full title

  A phase 2/3 multi-centre, randomised, open-label study to compare the efficacy and safety of Lenalidomide (Revlimid®) versus Investigator's choice in patients with relapsed or refractory diffuse large B-cell lymphoma

• IRAS ID

  51370

• Contact name

  David Cunningham

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2009-013483-38

• ISRCTN Number

  ISRCTN

• Research summary

  This is a randomized, multicenter, open-label, two-stage international study to determine the efficacy and safety of single agent lenalidomide (the IMP) versus Investigator's choice of a single agent in patients with Diffuse Large B-cell Lymphoma (DLBCL) who have relapsed after, or are refractory to, at least two prior lines of therapy. This study uses a 2-stage design. The objective of Stage 1 will be to select adequate subtype(s) of DLBCL for Stage 2. The subtypes, Germinal center B-cell (GCB), non-GCB, both subtypes, or neither subtype will be selected based on the overall response rate (ORR) in the individual subtype to lenalidomide monotherapy versus single agent of Investigator's choice. The objective of Stage 2 is to compare the progression free survival (PFS) of lenalidomide monotherapy versus single agent of Investigator's choice in the subtype(s) selected in Stage 1. Further exploratory objectives will also be conducted for this study, including the analysis of gene expression profiles associated with the sub-types and also the exploration of potential predictive biomarkers of clinical response or resistance to lenalidomide.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/53

• Date of REC Opinion

  22 Oct 2010

• REC opinion

  Further Information Favourable Opinion