Trial Information

A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent
lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis,
with median survival time as long as 10 years, but they are not usually curable in advanced
stages. Aggressive NHL constitutes about half of all cases of NHL in North America and
Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the
most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive
type of NHL has a shorter natural history; approximately 50-60% of these subjects can be
cured with combination chemotherapy regimens. Even with recent advances, many patients with
advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of
subjects who will eventually relapse or who are refractory to treatment.

Due to the variation in the clinical behavior of the different types of aggressive NHL, it
is important to test lenalidomide in DLBCL. Other studies are addressing the activity of
lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is
important to test lenalidomide in combination therapy. This study is focused on treating
subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral
dexamethasone.