A Study of Revlimid in the Treatment of Non-Hodgkin’s Lymphoma

Key Inclusion criteria

Biopsy proven aggressive non-hodgkin's lymphoma

Follicular center lymphoma Grade 3.
Diffuse large B-cell lymphoma.
Mantle cell lymphoma.
Transformed lymphoma.
Relapsed or refractory to previous therapy for lymphoma
At least one prior combination chemotherapy regime
Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
Willing to follow the pregnancy precautions

Key Exclusion criteria

Any of the following laboratory abnormalities.

Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5*10^9/L).
Platelet count < 60,000/mm^3 (60*10^9/L).
Calculated creatinine clearance of <50mL/min
Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
History of active Central Nervous System (CNS) lymphoma within the previous 6 months
History of other malignancies within the past year
Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C