A Phase 2/3 Multicenter, Randomized 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

Status
Active
Cancer Type
Non-Hodgkin Lymphoma
Trial Phase
Phase II
Phase III
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01197560
Protocol IDs
CC-5013-DLC-001 (primary)
Study Sponsor
Celgene Corporation

Summary

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

Objectives

This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. Diffuse Large B-cell Lymphoma (DLBCL)is just one type of lymphoma. Within Diffuse Large B-cell Lymphoma (DLBCL) there are two different subtypes called GCB and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and to doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both.

This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs.