Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Completed
• Trial end date: 2018-04-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Etoposide; Etoposide phosphate; Gemcitabine; Lenalidomide; Oxaliplatin; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL).

• Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant.

• Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI).

• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Exclusion Criteria:

• Diagnosis of lymphoma histologies other than DLBCL.

• History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more.

• Eligible for autologous stem cell transplant.

• Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV)

• Neuropathy grade 4.