Trial Information

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

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.