A multi-center, randomized, double-blind, placebo-controlled phase III trial omparing the efficacy of bevacizumab in combination with rituximab and CHOP (RA-CHOP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) - MAI

Conditions: Previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) who have low-intermediate, high-intermediate, or high-risk disease according to the IPI score and patients with bulky tumor (largest diameter = 7.5 cm) regardless of disease risk according to the IPI.
MedDRA version: 8.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma

Registration Number: EUCTR2006-005520-16-SE

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 787

Inclusion Criteria

• Patients previously randomized to the BO20603 study (MAIN) and who have received any cycle of study
treatment prior to termination of bevacizumab treatment by 31 May 2010.

• Previously randomized patients providing written informed consent to continue study participiation according to
this modified version of the study protocol (version D).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients not randomized to the BO20603 study prior to 01 June 2010 following the DSMB recommendation
which became effective on 31 May 2010.

• Previously randomized patients who are not willing to sign the amended informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To follow–up safety in previously untreated patients with diffuse large B cell lymphoma (DLBCL) with at least low-intermediate risk disease according to the IPI or bulky disease regardless of IPI risk category who were enrolled into the BO20603 study and treated with rituximab and CHOP (R-CHOP) alone versus patients treated<br>with any cycle of bevacizumab in combination with rituximab and CHOP (RA-CHOP).;Secondary Objective: Secondary objectives: not applicable<br><br>Exploratory objectives:<br>• To identify prognostic biomarkers for response to treatment<br>• To identify predictive biomarkers for safety;Primary end point(s): To follow-up safety in patients treated with R-CHOP versus patients treated with any cycle of bevacizumab in combination with rituximab and CHOP (RA-CHOP) in previously untreated patients with diffuse large B cell lymphoma (DLBCL) with at least low-intermediate risk disease according to the IPI or bulky disease regardless<br>of IPI risk category.

Secondary Outcome Measures