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

A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

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