A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

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

Details

• Lead Sponsor: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

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