A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

Summary

This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).

Conditions

• B-cell Lymphoma

Interventions

DRUG

Bevacizumab

Bevacizumab was administered at a dose of 15 mg/kg IV on Day 1 of each 21-day cycle for 8 cycles or at a dose 10 mg/kg IV on Day 1 of each 14-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

DRUG

Rituximab

Rituximab was administered at a dose of 375 mg/m\^2 IV on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

DRUG

CHOP

Cyclophosphamide was administered at a dose of 750 mg/m\^2 IV on Day 1 of each cycle. Doxorubicin was administered at a dose of 50 mg/m\^2 IV on Day 1 of each cycle. Vincristine was administered at a dose of 1.4 mg/m\^2 IV (maximum of 2 mg) on Day 1 of each cycle. Prednisone was administered at a dose of 100 mg orally on Days 1-5 of each cycle. All 4 drugs were administered either every 21 days for 8 cycles or every 14 days for 6 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

DRUG

Placebo

Placebo to bevacizumab was administered on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

Sponsors & Collaborators

• Genentech, Inc.

  collaborator INDUSTRY

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-26

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• United States
• Argentina
• Australia
• Austria
• Brazil
• Canada
• China
• Colombia
• Czechia
• Ecuador
• France
• Germany
• Greece
• Hong Kong
• Hungary
• Italy
• Lithuania
• Malaysia
• Mexico
• New Zealand
• Panama
• Peru
• Philippines
• Poland
• Portugal
• Russia
• Slovakia
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• United Kingdom

Study Locations