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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

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