Business decision

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.

Inclusion Criteria:

• Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
• Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
• Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
• ECOG performance score of 0,1 or 2
• Willing to follow the pregnancy precautions

Exclusion Criteria:

• Any of the following laboratory abnormalities.
• Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
• Platelet count < 60,000/mm3 (60 x 109/L).
• Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
• Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
• Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
• History of active CNS lymphoma within the previous 3 months
• Subjects not willing or unable to take DVT prophylaxis
• History of other malignancies within the past year
• Positive HIV or active Hepatitis B or C

The investigator shall have the right to publish and/or present the data generated from the study provided that the investigator shall (i) furnish the sponsor with a copy of any proposed publication or presentation at least thirty (30) days in advance of the submission of such material, (ii) delete from such material any confidential information of the sponsor, and (iii) delay submission of same for up to sixty (60) days to permit the preparation and filing of intellectual property applications.