Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
Query!
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)
Query!
Secondary ID [1]
0
0
BO20603
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
B-cell Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline to end of the study (up to 4 years, 4 months)
Query!
Secondary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
Query!
Timepoint [1]
0
0
Baseline to end of the study (up to 4 years, 4 months)
Query!
Secondary outcome [2]
0
0
Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
At the end of treatment (Cycle 8, up to 12 months)
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
79
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/07/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/11/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
787
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Greenslopes Private Hospital; Gallipoli Research Centre - Greenslopes
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science - Adelaide
Query!
Recruitment hospital [4]
0
0
Ashford Cancer Center Research - Kurralta Park
Query!
Recruitment hospital [5]
0
0
Frankston Hospital; Oncology/Haematology - Frankston
Query!
Recruitment hospital [6]
0
0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Query!
Recruitment hospital [7]
0
0
Alfred Hospital; Bone Marrow Transplant Unit - Melbourne
Query!
Recruitment hospital [8]
0
0
Border Medical Oncology; Murray Valley Private Hospital - Wodonga
Query!
Recruitment hospital [9]
0
0
Fremantle Hospital; Haematology - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [5]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [6]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3181 - Melbourne
Query!
Recruitment postcode(s) [8]
0
0
3690 - Wodonga
Query!
Recruitment postcode(s) [9]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Oregon
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
South Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Washington
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Buenos Aires
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Córdoba
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Graz
Query!
Country [15]
0
0
Austria
Query!
State/province [15]
0
0
Salzburg
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Wien
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
GO
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
RS
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
SP
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Alberta
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Manitoba
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
New Brunswick
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Newfoundland and Labrador
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Nova Scotia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Quebec
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Saskatchewan
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Beijing
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Fuzhou
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Shanghai
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Suzhou
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Tianjin
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Xi'an
Query!
Country [34]
0
0
Colombia
Query!
State/province [34]
0
0
Bogota
Query!
Country [35]
0
0
Colombia
Query!
State/province [35]
0
0
Medellin-Antioquia
Query!
Country [36]
0
0
Colombia
Query!
State/province [36]
0
0
Medellin
Query!
Country [37]
0
0
Colombia
Query!
State/province [37]
0
0
Pereira
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Brno
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Hradec Kralove
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Olomouc
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Plzen - Lochotin
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Praha 2
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Praha
Query!
Country [44]
0
0
Ecuador
Query!
State/province [44]
0
0
Guayaquil
Query!
Country [45]
0
0
Ecuador
Query!
State/province [45]
0
0
Quito
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Albi
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Angers
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Bordeaux
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Caen
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Clermont Ferrand
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Dijon
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
La Roche Sur Yon
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
La Tronche
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Le Mans
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Lille
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Limoges
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Lyon
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Marseille
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Montauban
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Montpellier
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Nice
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Nimes
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Paris
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Perpignan
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Pessac
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Pierre Benite
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Poitiers
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Rodez
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Saint-Priest en Jarez
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Salouel
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Toulouse
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Tours
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Vandoeuvre Les Nancy
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Villejuif
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Amberg
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Berlin
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Bremen
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Cottbus
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Dortmund
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Eschweiler
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Frankfurt
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Fulda
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Greifswald
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Göttingen
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Hagen
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Hamburg
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Hamm
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Hannover
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Hildesheim
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Homburg/Saar
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Karlsruhe
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Landshut
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Leipzig
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Ludwigshafen
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Lübeck
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Lüdenscheid
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Magdeburg
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Mannheim
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Muenchen
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Münster
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Oldenburg
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Recklinghausen
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Siegen
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Trier
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Tübingen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Ulm
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Wiesbaden
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Wuppertal
Query!
Country [109]
0
0
Greece
Query!
State/province [109]
0
0
Thessaloniki
Query!
Country [110]
0
0
Hong Kong
Query!
State/province [110]
0
0
Hong Kong
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Budapest
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Debrecen
Query!
Country [113]
0
0
Italy
Query!
State/province [113]
0
0
Emilia-Romagna
Query!
Country [114]
0
0
Italy
Query!
State/province [114]
0
0
Friuli-Venezia Giulia
Query!
Country [115]
0
0
Italy
Query!
State/province [115]
0
0
Lazio
Query!
Country [116]
0
0
Italy
Query!
State/province [116]
0
0
Lombardia
Query!
Country [117]
0
0
Italy
Query!
State/province [117]
0
0
Marche
Query!
Country [118]
0
0
Italy
Query!
State/province [118]
0
0
Molise
Query!
Country [119]
0
0
Italy
Query!
State/province [119]
0
0
Piemonte
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Puglia
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Sicilia
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Toscana
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Seoul
Query!
Country [124]
0
0
Lithuania
Query!
State/province [124]
0
0
Klaipeda
Query!
Country [125]
0
0
Lithuania
Query!
State/province [125]
0
0
Vilnius
Query!
Country [126]
0
0
Malaysia
Query!
State/province [126]
0
0
Penang
Query!
Country [127]
0
0
Mexico
Query!
State/province [127]
0
0
Aguascalientes
Query!
Country [128]
0
0
Mexico
Query!
State/province [128]
0
0
Mexico City
Query!
Country [129]
0
0
Mexico
Query!
State/province [129]
0
0
Monterrey
Query!
Country [130]
0
0
New Zealand
Query!
State/province [130]
0
0
Auckland
Query!
Country [131]
0
0
New Zealand
Query!
State/province [131]
0
0
Christchurch
Query!
Country [132]
0
0
Panama
Query!
State/province [132]
0
0
Panama City
Query!
Country [133]
0
0
Peru
Query!
State/province [133]
0
0
Chiclayo
Query!
Country [134]
0
0
Peru
Query!
State/province [134]
0
0
Lima
Query!
Country [135]
0
0
Philippines
Query!
State/province [135]
0
0
Cebu
Query!
Country [136]
0
0
Philippines
Query!
State/province [136]
0
0
Diliman, Quezon City
Query!
Country [137]
0
0
Philippines
Query!
State/province [137]
0
0
Quezon City
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Brzozów
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Krakow
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Lodz
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Lublin
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Olsztyn
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Warszawa
Query!
Country [144]
0
0
Portugal
Query!
State/province [144]
0
0
Coimbra
Query!
Country [145]
0
0
Portugal
Query!
State/province [145]
0
0
Lisboa
Query!
Country [146]
0
0
Portugal
Query!
State/province [146]
0
0
Porto
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Kazan
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Moscow
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
St Petersburg
Query!
Country [150]
0
0
Slovakia
Query!
State/province [150]
0
0
Bratislava
Query!
Country [151]
0
0
Spain
Query!
State/province [151]
0
0
Barcelona
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Cantabria
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
La Coruña
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
Tenerife
Query!
Country [155]
0
0
Spain
Query!
State/province [155]
0
0
Vizcaya
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
Jaen
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Madrid
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Malaga
Query!
Country [159]
0
0
Spain
Query!
State/province [159]
0
0
Salamanca
Query!
Country [160]
0
0
Spain
Query!
State/province [160]
0
0
Sevilla
Query!
Country [161]
0
0
Spain
Query!
State/province [161]
0
0
Valencia
Query!
Country [162]
0
0
Spain
Query!
State/province [162]
0
0
Zaragoza
Query!
Country [163]
0
0
Sweden
Query!
State/province [163]
0
0
Lund
Query!
Country [164]
0
0
Sweden
Query!
State/province [164]
0
0
Malmö
Query!
Country [165]
0
0
Sweden
Query!
State/province [165]
0
0
Sundsvall
Query!
Country [166]
0
0
Sweden
Query!
State/province [166]
0
0
Uppsala
Query!
Country [167]
0
0
Switzerland
Query!
State/province [167]
0
0
Zürich
Query!
Country [168]
0
0
Taiwan
Query!
State/province [168]
0
0
Taipei
Query!
Country [169]
0
0
Taiwan
Query!
State/province [169]
0
0
Taoyuan
Query!
Country [170]
0
0
Thailand
Query!
State/province [170]
0
0
Bangkok
Query!
Country [171]
0
0
Thailand
Query!
State/province [171]
0
0
Chiang Mai
Query!
Country [172]
0
0
Thailand
Query!
State/province [172]
0
0
Khon Kaen
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Birmingham
Query!
Country [174]
0
0
United Kingdom
Query!
State/province [174]
0
0
Bradford
Query!
Country [175]
0
0
United Kingdom
Query!
State/province [175]
0
0
Hampshire
Query!
Country [176]
0
0
United Kingdom
Query!
State/province [176]
0
0
Harlow
Query!
Country [177]
0
0
United Kingdom
Query!
State/province [177]
0
0
Leicester
Query!
Country [178]
0
0
United Kingdom
Query!
State/province [178]
0
0
Liverpool
Query!
Country [179]
0
0
United Kingdom
Query!
State/province [179]
0
0
London
Query!
Country [180]
0
0
United Kingdom
Query!
State/province [180]
0
0
Middx
Query!
Country [181]
0
0
United Kingdom
Query!
State/province [181]
0
0
Oxford
Query!
Country [182]
0
0
United Kingdom
Query!
State/province [182]
0
0
Sheffield
Query!
Country [183]
0
0
United Kingdom
Query!
State/province [183]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Genentech, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00486759
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00486759
Download to PDF