Trial information

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 type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study

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:

• adult patients, >=18 years of age;
• CD20-positive diffuse large B-cell lymphoma;
• low-intermediate, high-intermediate or high risk disease and/or bulky tumor (.7.5 cm);
• ECOG performance status 0-2.

Exclusion criteria:

• prior treatment for diffuse large B-cell lymphoma;
• types of non-Hodgkin's lymphoma other than DLBCL;
• CNS involvement of lymphoma.

Gender: Males or Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: July, 2007

Trial registration date: 06/15/2007

Date last updated: 8/29/2008

Link to trial result

This trial is being conducted at the following locations:

Australia

• Adelaide
• Frankston
• Fremantle
• Melbourne
• Woolloongabba

Austria

• Graz
• Salzburg
• Wien

Brazil

• Campinas
• Porto Alegre
• Santo Andre
• Sao Paulo

Canada

• Edmonton, AB
• Moncton, NB
• Halifax, NS
• Kingston, ON
• Mississauga, ON
• Toronto, ON
• Windsor, ON
• Quebec City, QC
• Saskatoon, SK

China

• Beijing
• Hong Kong
• Shanghai
• Tianjin
• Xi'An

Czech Republic

• Brno
• Hradec Kralove
• Olomouc
• Plzen
• Praha

France

• Angers
• Bordeaux
• Clermont-Ferrand
• Dijon
• Grenoble
• La Roche Sur Yon
• Le Mans
• Lille
• Limoges
• Lyon
• Marseille
• Montpellier
• Nice
• Nimes
• Paris
• Perpignan
• Pessac
• Pierre Benite
• Poitiers
• Saint-Priest-En-Jarez
• Salouel
• Toulouse
• Tours
• Vandoeuvre-Les-Nancy
• Villejuif

Germany

• Amberg
• Berlin
• Bremen
• Cottbus
• Dortmund
• Frankfurt Am Main
• Fulda
• Göttingen
• Greifswald
• Hagen
• Hamburg
• Hamm
• Hannover
• Hildesheim
• Homburg
• Homburg/Saar
• Karlsruhe
• Landshut
• Leipzig
• Lübeck
• Lüdenscheid
• Ludwigshafen
• Magdeburg
• Mannheim
• München
• Münster
• Oldenburg
• Siegen
• Trier
• Tübingen
• Ulm
• Wiesbaden
• Wuppertal

Greece

• Thessaloniki

Italy

• Aviano
• Bari
• Bologna
• Campobasso
• Catania
• Monza
• Orbassano
• Pavia
• Pisa
• Reggio Emilia
• Roma
• Torino
• Udine

Mexico

• Aguascalientes
• Mexico City
• Monterrey

New Zealand

• Auckland
• Christchurch

Peru

• Chiclayo
• Lima

Poland

• Krakow
• Lodz
• Lublin
• Warszawa

Portugal

• Coimbra
• Lisboa
• Porto

Russian Federation

• Moscow
• St Petersburg

Slovakia

• Bratislava

Spain

• Barcelona
• Bilbao
• Hospitalet de Llobregat
• Madrid
• Malaga
• Salamanca
• Santander
• Sevilla
• Valencia
• Zaragoza

Sweden

• Lund
• Malmoe
• Uppsala

Switzerland

• Zürich

Taiwan

• Taipei

Thailand

• Bangkok

United Kingdom

• Basingstoke
• Birmingham
• Bradford
• Harlow
• Leicester
• Liverpool
• London
• Middx
• Oxford
• Sheffield
• Wolverhampton

United States

• La Jolla, CA
• Los Angeles, CA
• Aurora, CO
• Jacksonville, FL
• West Palm Beach, FL
• Marietta, GA
• Kansas City, KS
• Ann Arbor, MI
• Concord, NC
• Winston-Salem, NC
• Portland, OR
• Charleston, SC
• Dallas, TX
• San Antonio, TX
• Federal Way, WA
• Puyallup, WA
• Tacoma, WA