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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00486759




Registration number
NCT00486759
Ethics application status
Date submitted
14/06/2007
Date registered
15/06/2007
Date last updated
25/07/2017

Titles & IDs
Public title
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
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Comparing the Efficacy of Bevacizumab in Combination With Rituximab and CHOP (R-CHOP + Bevacizumab) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
BO20603
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Rituximab
Treatment: Drugs - CHOP
Treatment: Drugs - Placebo

Experimental: Bevacizumab + rituximab + CHOP - Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).

Active Comparator: Placebo + rituximab + CHOP - Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) - PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) = 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by = 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) = 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.
Timepoint [1] 0 0
Baseline to end of the study (up to 4 years, 4 months)
Secondary outcome [1] 0 0
Overall Survival - Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
Timepoint [1] 0 0
Baseline to end of the study (up to 4 years, 4 months)
Secondary outcome [2] 0 0
Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma - OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (= 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and = 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = = 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by = 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.
Timepoint [2] 0 0
At the end of treatment (Cycle 8, up to 12 months)

Eligibility
Key inclusion criteria
- Adult patients, = 18 and < 80 years of age.

- CD20-positive diffuse large B-cell lymphoma.

- Low-intermediate, high-intermediate, or high risk disease and/or bulky tumor (largest
diameter = 7.5 cm).

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Minimum age
18 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment for diffuse large B-cell lymphoma.

- Types of non-Hodgkin's lymphoma other than diffuse large B-cell lymphoma (DLBCL).

- Central nervous system (CNS) involvement of lymphoma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Greenslopes Private Hospital; Gallipoli Research Centre - Greenslopes
Recruitment hospital [2] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science - Adelaide
Recruitment hospital [4] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [5] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [6] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment hospital [7] 0 0
Alfred Hospital; Bone Marrow Transplant Unit - Melbourne
Recruitment hospital [8] 0 0
Border Medical Oncology; Murray Valley Private Hospital - Wodonga
Recruitment hospital [9] 0 0
Fremantle Hospital; Haematology - Fremantle
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3181 - Melbourne
Recruitment postcode(s) [8] 0 0
3690 - Wodonga
Recruitment postcode(s) [9] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Colorado
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Georgia
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Kansas
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Michigan
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North Carolina
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Oregon
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South Carolina
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Texas
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Washington
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Austria
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Graz
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Austria
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Salzburg
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Austria
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Wien
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Brazil
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GO
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Brazil
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RS
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Brazil
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SP
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Canada
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Alberta
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Manitoba
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New Brunswick
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Suzhou
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China
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Tianjin
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China
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Xi'an
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Bogota
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Colombia
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Medellin-Antioquia
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Colombia
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Medellin
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Pereira
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Brno
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Hradec Kralove
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Olomouc
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Praha
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Pierre Benite
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Poitiers
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Rodez
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Tours
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Vandoeuvre Les Nancy
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Villejuif
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Germany
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Amberg
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Berlin
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Bremen
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Cottbus
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Hagen
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Hamm
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Hannover
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Hildesheim
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Karlsruhe
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Landshut
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Leipzig
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Lüdenscheid
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Mannheim
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Muenchen
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Münster
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Germany
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Oldenburg
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Germany
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Recklinghausen
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Germany
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Siegen
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Germany
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Trier
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Germany
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Tübingen
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Germany
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Ulm
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Germany
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Wiesbaden
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Germany
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Wuppertal
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Greece
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Hong Kong
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Hungary
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Budapest
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Hungary
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Debrecen
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Italy
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Marche
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Italy
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Molise
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Italy
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Italy
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Italy
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Sicilia
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Italy
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Toscana
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Korea, Republic of
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Seoul
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Lithuania
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Lima
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Cebu
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Philippines
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Diliman, Quezon City
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Brzozów
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Lublin
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Olsztyn
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Moscow
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Russian Federation
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Malaga
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Salamanca
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Sevilla
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Valencia
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Spain
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Zaragoza
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Sweden
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Lund
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Sweden
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Malmö
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Sweden
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Sundsvall
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Sweden
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Uppsala
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Switzerland
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Zürich
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Taiwan
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Taipei
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Taiwan
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Taoyuan
Country [170] 0 0
Thailand
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Bangkok
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Thailand
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Chiang Mai
Country [172] 0 0
Thailand
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Khon Kaen
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Birmingham
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Bradford
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Hampshire
Country [176] 0 0
United Kingdom
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Harlow
Country [177] 0 0
United Kingdom
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Leicester
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Liverpool
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United Kingdom
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London
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United Kingdom
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Middx
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United Kingdom
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Oxford
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Sheffield
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/show/NCT00486759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00486759