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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01419665
Registration number
NCT01419665
Ethics application status
Date submitted
17/08/2011
Date registered
18/08/2011
Titles & IDs
Public title
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
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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
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Secondary ID [1]
0
0
2010-019522-13
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Secondary ID [2]
0
0
GP13-301
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Universal Trial Number (UTN)
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Trial acronym
ASSIST_FL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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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: Other - GP2013
Treatment: Other - rituximab
Experimental: GP2013 - Type: Biological/Vaccine
Active comparator: rituximab - Type: Biological/Vaccine
Treatment: Other: GP2013
Type: Biological/Vaccine
Treatment: Other: rituximab
Type: Biological/Vaccine
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Intervention code [1]
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0
Treatment: Other
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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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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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0
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
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Assessment method [1]
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0
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Timepoint [1]
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0
24 weeks
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Secondary outcome [2]
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0
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
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Assessment method [2]
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0
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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0
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
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Assessment method [3]
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0
Number of participants with progression free survival events
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Timepoint [3]
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3 years
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Secondary outcome [4]
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0
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
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Assessment method [4]
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0
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
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Timepoint [4]
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3 years
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Secondary outcome [5]
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0
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
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Assessment method [5]
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0
number of participants with confirmed positive ADA
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Timepoint [5]
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24 weeks, 3 years
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Secondary outcome [6]
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To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
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Assessment method [6]
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C max
For descriptive purposes only, no hypothesis testing
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Timepoint [6]
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day 63
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Secondary outcome [7]
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0
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
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Assessment method [7]
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C through
For descriptive purposes only, no hypothesis testing
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Timepoint [7]
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0
day 63
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Secondary outcome [8]
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0
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
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Assessment method [8]
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AUEC (0-21d)
For descriptive purposes only, no hypothesis testing
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Timepoint [8]
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21 days
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Eligibility
Key inclusion criteria
* Patient with previously untreated advanced stage, CD20-positive FL
* Patient with ECOG performance status 0, 1 or 2.
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Minimum age
18
Years
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Maximum age
No limit
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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
* 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
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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 administering the treatment/s
The people assessing the outcomes
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
Completed
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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
1/12/2011
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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
22/01/2018
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Sample size
Target
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Accrual to date
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Final
629
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigative site - Adelaide
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Recruitment hospital [2]
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Investigative site - Ballarat
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Recruitment hospital [3]
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Investigative site - Epping
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Recruitment hospital [4]
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Investigative site - Footscray
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Recruitment hospital [5]
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Investigative site - Wodonga
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Ballarat
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Recruitment postcode(s) [3]
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- Epping
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Recruitment postcode(s) [4]
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- Footscray
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Recruitment postcode(s) [5]
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- Wodonga
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Recruitment outside Australia
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Austria
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Graz
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Austria
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Wien
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Brazil
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Brazil
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Botucatu
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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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Colmar
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Koblenz
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Athens
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India
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India
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Madurai
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India
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India
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Nashik
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India
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New Delhi
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India
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Pune
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India
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Surat
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Israel
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Nahariya
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Bari
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Italy
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Piacenza
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Ravenna
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Italy
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Reggio Calabria
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Italy
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Varese
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Aomori
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Fukuoka
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Gifu
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Ogaki
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Saga
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Tachikawa
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Otake
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Alor Setar
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Ampang
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George Town
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Ipoh
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Johor Bahru
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Klang
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Subang Jaya
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Amsterdam
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Delft
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Gouda
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Heerlen
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Rotterdam
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Zwolle
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Peru
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Lima
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Johannesburg
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Country [129]
0
0
South Africa
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State/province [129]
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0
Port Elizabeth
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Country [130]
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0
South Africa
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State/province [130]
0
0
Pretoria
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Country [131]
0
0
Spain
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State/province [131]
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0
Barcelona
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Country [132]
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0
Spain
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State/province [132]
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0
Madrid
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Country [133]
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0
Spain
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State/province [133]
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0
Oviedo
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Country [134]
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0
Spain
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State/province [134]
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San Sebastian
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Country [135]
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Spain
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State/province [135]
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Sevilla
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Country [136]
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Spain
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State/province [136]
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Zaragoza
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Country [137]
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Ukraine
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State/province [137]
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0
Cherkasy
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Country [138]
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0
Ukraine
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State/province [138]
0
0
Dnipropetrovsk
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Country [139]
0
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Ukraine
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State/province [139]
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0
Donetsk
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Country [140]
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Ukraine
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State/province [140]
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0
Ivano-Frankivsk
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Country [141]
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0
Ukraine
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State/province [141]
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Kharkiv
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Country [142]
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Ukraine
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State/province [142]
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Kyiv
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Country [143]
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Ukraine
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State/province [143]
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Lviv
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Country [144]
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United Kingdom
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State/province [144]
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Eastbourne
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Country [145]
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United Kingdom
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State/province [145]
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London
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Country [146]
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0
United Kingdom
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State/province [146]
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0
Worthing
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sandoz
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Novartis Pharmaceuticals
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01419665
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Trial related presentations / publications
Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017 Aug;4(8):e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.
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Public notes
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Contacts
Principal investigator
Name
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Fax
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Email
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Contact person for public queries
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0
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Phone
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Fax
0
0
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Email
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0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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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/NCT01419665