Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-Cell Type Diffuse Large B-Cell Lymphoma

Phase 3

Recruiting

Conditions: Previously Untreated Activated B-Cell Type Diffuse Large B-Cell Lymphoma
10025320

Registration Number: NL-OMON45071

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 44

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression-free Survival (PFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary endpoint:<br /><br>Event-free Survival (EFS)<br /><br><br /><br>Other secondary endpoints:<br /><br>• Overall Survival (OS)<br /><br>• Complete Response (CR) rate<br /><br>• Duration of CR<br /><br>• Time to next lymphoma therapy (TTNLT)<br /><br>• Objective response rate (ORR)<br /><br>• Health-related quality of life (HRQoL) as measured by the EuroQuol 5<br /><br>Dimension Scale (EQ-5D) and the Functional Assessment of Cancer Therapy for<br /><br>Patients with Lymphoma (FACT-Lym) standardized measures of health status<br /><br><br /><br>Exploratory Endpoints:<br /><br>• Progression-free Survival 2 (PFS2)<br /><br>• Correlation of MRD status to clinical outcome measures such as PFS and OS,<br /><br>and sensitivity and specificity of the MRD NGS test<br /><br>• Correlation of pretreatment levels of molecular markers with clinical outcome</p><br>