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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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)
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Secondary ID [1]
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BO20603
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to end of the study (up to 4 years, 4 months)
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Baseline to end of the study (up to 4 years, 4 months)
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Secondary outcome [2]
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Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma
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Assessment method [2]
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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.
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Timepoint [2]
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At the end of treatment (Cycle 8, up to 12 months)
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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.
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Minimum age
18
Years
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Maximum age
79
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/07/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/11/2011
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Sample size
Target
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Accrual to date
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Final
787
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Greenslopes Private Hospital; Gallipoli Research Centre - Greenslopes
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Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
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Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science - Adelaide
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Ashford Cancer Center Research - Kurralta Park
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Frankston Hospital; Oncology/Haematology - Frankston
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Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
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Alfred Hospital; Bone Marrow Transplant Unit - Melbourne
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Border Medical Oncology; Murray Valley Private Hospital - Wodonga
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Fremantle Hospital; Haematology - Fremantle
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4120 - Greenslopes
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4102 - Woolloongabba
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5000 - Adelaide
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5037 - Kurralta Park
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3199 - Frankston
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3000 - Melbourne
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3181 - Melbourne
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3690 - Wodonga
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6160 - Fremantle
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Lombardia
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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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Piemonte
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Italy
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Puglia
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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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Klaipeda
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Lithuania
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Vilnius
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Malaysia
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Penang
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Mexico
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Aguascalientes
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Mexico
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Mexico
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Cebu
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Philippines
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Philippines
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Quezon City
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Poland
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Brzozów
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Krakow
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Lodz
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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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Portugal
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Kazan
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Russian Federation
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Barcelona
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Spain
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La Coruña
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Spain
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Tenerife
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Vizcaya
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Spain
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Jaen
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Spain
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Madrid
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Malaga
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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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Taoyuan
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Bangkok
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Thailand
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Thailand
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United Kingdom
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Birmingham
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Bradford
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United Kingdom
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Hampshire
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United Kingdom
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Harlow
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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Middx
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United Kingdom
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Oxford
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United Kingdom
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Sheffield
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Genentech, Inc.
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Ethics approval
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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).
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Trial website
https://clinicaltrials.gov/study/NCT00486759
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Trial related presentations / publications
McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602. Seymour JF, Pfreundschuh M, Trneny M, Sehn LH, Catalano J, Csinady E, Moore N, Coiffier B; MAIN Study Investigators. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014 Aug;99(8):1343-9. doi: 10.3324/haematol.2013.100818. Epub 2014 Jun 3.
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Public notes
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Contacts
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00486759
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