Study of lenalidomide plus R-CHOP chemotherapy versus placebo plus R-CHOP chemotherapy in untreated diffuse large B-cell lymphoma

• Conditions: Previously untreated, activated B-cell (ABC) type diffuse large B-cell lymphoma (DLBCL).; MedDRA version: 17.0Level: LLTClassification code 10012859Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IISystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)System Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10012860Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IIISystem Organ Class: 100000004864; MedDRA version: 17.0Level: LLTClassification code 10012861Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004054-21-IT
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-01
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

-Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL) of the ABC type.
-Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma (DLBCL)
-Measurable Diffuse Large B-Cell Lymphoma (DLBCL) disease by Computed Tomography (CT)
-Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
Age 18 -80 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 392

Exclusion Criteria

-Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma (DLBCL).
-History of malignancies, other than Diffuse Large B-Cell Lymphoma (DLBCL), unless the patient has been disease free for 5 years or more.
-Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
-Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF < 45% or peripheral neuropathy grade > =2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified