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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03814785




Registration number
NCT03814785
Ethics application status
Date submitted
21/01/2019
Date registered
21/01/2019
Date last updated
21/01/2019

Titles & IDs
Public title
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
Scientific title
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma
Secondary ID [1] 0 0
2010-019522-13
Secondary ID [2] 0 0
GP13-301
Universal Trial Number (UTN)
Trial acronym
ASSIST_FL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular 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
Other interventions - GP2013
Other interventions - rituximab

Experimental: GP2013 - Type: Biological/Vaccine

Active Comparator: rituximab - Type: Biological/Vaccine


Other interventions: GP2013
Type: Biological/Vaccine

Other interventions: rituximab
Type: Biological/Vaccine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate in patients with FL
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Percentage of patients with Adverse Events (AEs)
Timepoint [1] 0 0
up to 2 years

Eligibility
Key inclusion criteria
- Patient with previously untreated advanced stage, CD20-positive FL

- Patient with ECOG performance status 0, 1 or 2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a

- Patient who has previously received any prior therapy for lymphoma

- Patient with evidence of any uncontrolled, active infection (viral, bacterial or
fungal).

- Patient with any malignancy within 5 years prior to date of randomization, with the
exception of adequately treated in situ carcinoma of the cervix uteri, basal or
squamous cell carcinoma or non-melanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply

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 administering the treatment/s
The people assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2018
Sample size
Target
Accrual to date
Final
629
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigative site - Adelaide
Recruitment hospital [2] 0 0
Investigative site - Ballarat
Recruitment hospital [3] 0 0
Investigative site - Epping
Recruitment hospital [4] 0 0
Investigative site - Footscray
Recruitment hospital [5] 0 0
Investigative site - Wodonga
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Epping
Recruitment postcode(s) [4] 0 0
- Footscray
Recruitment postcode(s) [5] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
La Plata
Country [2] 0 0
Argentina
State/province [2] 0 0
Rosario
Country [3] 0 0
Argentina
State/province [3] 0 0
San Miguel de Tucuman
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Brazil
State/province [6] 0 0
Barretos
Country [7] 0 0
Brazil
State/province [7] 0 0
Botucatu
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Florianopolis
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Brazil
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Fortaleza
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Brazil
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Goiania
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Brazil
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Jau
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Colombia
State/province [25] 0 0
Medellin
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Colombia
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Monteria
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France
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Colmar
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France
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Nimes
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France
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Strasbourg
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Germany
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Bad Saarow
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Germany
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Koblenz
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Patras
Country [36] 0 0
Hungary
State/province [36] 0 0
Györ
Country [37] 0 0
Hungary
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Kaposvar
Country [38] 0 0
India
State/province [38] 0 0
Ahmedabad
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India
State/province [39] 0 0
Amritsar
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India
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Aurangabad
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India
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Bangalore
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India
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Chennai
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India
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Hyderabad
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India
State/province [44] 0 0
Kolkata
Country [45] 0 0
India
State/province [45] 0 0
Madurai
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India
State/province [46] 0 0
Mumbai
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India
State/province [47] 0 0
Nashik
Country [48] 0 0
India
State/province [48] 0 0
New Delhi
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India
State/province [49] 0 0
Pune
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India
State/province [50] 0 0
Surat
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India
State/province [51] 0 0
Trivandrum
Country [52] 0 0
India
State/province [52] 0 0
Vellore
Country [53] 0 0
Ireland
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Dublin
Country [54] 0 0
Ireland
State/province [54] 0 0
Limerick
Country [55] 0 0
Ireland
State/province [55] 0 0
Waterford
Country [56] 0 0
Israel
State/province [56] 0 0
Ashkelon
Country [57] 0 0
Israel
State/province [57] 0 0
Nahariya
Country [58] 0 0
Italy
State/province [58] 0 0
Bari
Country [59] 0 0
Italy
State/province [59] 0 0
Firenze
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Italy
State/province [60] 0 0
Meldola
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Italy
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Milano
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Italy
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Palermo
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Italy
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Pavia
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Italy
State/province [64] 0 0
Pescara
Country [65] 0 0
Italy
State/province [65] 0 0
Piacenza
Country [66] 0 0
Italy
State/province [66] 0 0
Ravenna
Country [67] 0 0
Italy
State/province [67] 0 0
Reggio Calabria
Country [68] 0 0
Italy
State/province [68] 0 0
Varese
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Japan
State/province [69] 0 0
Aomori
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Kagoshima
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Japan
State/province [73] 0 0
Kitakyushu
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Japan
State/province [74] 0 0
Kobe
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Japan
State/province [75] 0 0
Komaki
Country [76] 0 0
Japan
State/province [76] 0 0
Matsuyama
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Japan
State/province [77] 0 0
Ogaki
Country [78] 0 0
Japan
State/province [78] 0 0
Okayama
Country [79] 0 0
Japan
State/province [79] 0 0
Omura
Country [80] 0 0
Japan
State/province [80] 0 0
Saga
Country [81] 0 0
Japan
State/province [81] 0 0
Tachikawa
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Japan
State/province [82] 0 0
Otake
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Malaysia
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Alor Setar
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Malaysia
State/province [84] 0 0
Ampang
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Malaysia
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George Town
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Malaysia
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Ipoh
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Malaysia
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Johor Bahru
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Malaysia
State/province [88] 0 0
Klang
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Malaysia
State/province [89] 0 0
Kuala Lumpur
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Malaysia
State/province [90] 0 0
Kuching
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Malaysia
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Melaka
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Malaysia
State/province [92] 0 0
Pulau Pinang
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Malaysia
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Subang Jaya
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Netherlands
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Amsterdam
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Netherlands
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Delft
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Netherlands
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Gouda
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Netherlands
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Heerlen
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Netherlands
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Rotterdam
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Netherlands
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Schiedam
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Netherlands
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Sittard
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Netherlands
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Zwolle
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Peru
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Lima
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Poland
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Brzozow
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Krakow
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Poland
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Lublin
Country [108] 0 0
Poland
State/province [108] 0 0
Warszawa
Country [109] 0 0
Portugal
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Braga
Country [110] 0 0
Portugal
State/province [110] 0 0
Coimbra
Country [111] 0 0
Portugal
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Lisboa
Country [112] 0 0
Portugal
State/province [112] 0 0
Porto
Country [113] 0 0
Romania
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Brasov
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Romania
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Bucharest
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Romania
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Cluj-Napoca
Country [116] 0 0
Romania
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Iasi
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Romania
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Timisoara
Country [118] 0 0
Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Krasnodar
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Russian Federation
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Kursk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
Country [124] 0 0
Russian Federation
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Rostov-on -Don
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Russian Federation
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St. Petersburg
Country [126] 0 0
South Africa
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Cape Town
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South Africa
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George
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South Africa
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Johannesburg
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South Africa
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Port Elizabeth
Country [130] 0 0
South Africa
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Pretoria
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Spain
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Barcelona
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Spain
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Madrid
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Oviedo
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Spain
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San Sebastian
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Spain
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Sevilla
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Spain
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Zaragoza
Country [137] 0 0
Ukraine
State/province [137] 0 0
Cherkasy
Country [138] 0 0
Ukraine
State/province [138] 0 0
Dnipropetrovsk
Country [139] 0 0
Ukraine
State/province [139] 0 0
Donetsk
Country [140] 0 0
Ukraine
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Ivano-Frankivsk
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kharkiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Kyiv
Country [143] 0 0
Ukraine
State/province [143] 0 0
Lviv
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Eastbourne
Country [145] 0 0
United Kingdom
State/province [145] 0 0
London
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Worthing

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sandoz
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate comparability of the ORR in patients with
previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive
MabThera-treatment.
Trial website
https://clinicaltrials.gov/show/NCT03814785
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/show/NCT03814785