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-AT
- 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
• 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
• 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
- Secondary Outcome Measures
Name Time Method