Trial Information

Summary: A Study of Avastin (Bevacizumab) in Combination With MabThera (Rituximab) and CHOP Chemotherapy in Patients With Diffuse Large B-Cell Lymphoma.

Status: Recruiting

Protocol Number: BO20603

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind placebo-controlled study comparing the effect of Avastin in combination with MabThera plus CHOP, and MabThera plus CHOP alone, on progression-free survival in previously untreated patients with CD20-positive diffuse large B-cell lymphoma.

Brief Summary: This 2 arm study will compare the efficacy and safety of Avastin in combination with MabThera and CHOP chemotherapy (RA-CHOP) versus MabThera plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients will be randomized to 8 cycles of treatment with R-CHOP plus Avastin, or R-CHOP plus placebo. The treatment with Avastin/Placebo and R-CHOP will be given either as a 2 weekly or 3 weekly schedule, and Avastin will be given at a weekly average dose of 5mg/kg (10mg/kg for 2 weekly cycles and 15mg/kg for 3 weekly cycles). Responding patients will continue on Avastin monotherapy (15mg/kg every 3 weeks) for up to 1 year. The anticipated time on treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 1060.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Lymphoma, B-Cell

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: 1. Progression-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall survival, event-free survival, disease-free survival, overall response rate, complete response rate. Time frame: Event driven 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2007

Trial Registration Date: 06/15/2007

Date Last Updated: 06/17/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: June 30, 2008 at 3:15:35 PM