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

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
Timepoint [5] 0 0
24 weeks, 3 years
Secondary outcome [6] 0 0
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
Timepoint [6] 0 0
day 63
Secondary outcome [7] 0 0
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
Timepoint [7] 0 0
day 63
Secondary outcome [8] 0 0
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
Timepoint [8] 0 0
21 days

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
Country [8] 0 0
Brazil
State/province [8] 0 0
Campinas
Country [9] 0 0
Brazil
State/province [9] 0 0
Curitiba
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Brazil
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Florianopolis
Country [11] 0 0
Brazil
State/province [11] 0 0
Fortaleza
Country [12] 0 0
Brazil
State/province [12] 0 0
Goiania
Country [13] 0 0
Brazil
State/province [13] 0 0
Jau
Country [14] 0 0
Brazil
State/province [14] 0 0
Passo Fundo
Country [15] 0 0
Brazil
State/province [15] 0 0
Porto Alegre
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio de Janeiro
Country [17] 0 0
Brazil
State/province [17] 0 0
Santo Andre
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Brazil
State/province [19] 0 0
Sorocaba
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Pleven
Country [21] 0 0
Bulgaria
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Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Ruse
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
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Bulgaria
State/province [24] 0 0
Varna
Country [25] 0 0
Colombia
State/province [25] 0 0
Medellin
Country [26] 0 0
Colombia
State/province [26] 0 0
Monteria
Country [27] 0 0
France
State/province [27] 0 0
Colmar
Country [28] 0 0
France
State/province [28] 0 0
Nimes
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France
State/province [29] 0 0
Strasbourg
Country [30] 0 0
Germany
State/province [30] 0 0
Bad Saarow
Country [31] 0 0
Germany
State/province [31] 0 0
Koblenz
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
Country [33] 0 0
Greece
State/province [33] 0 0
Ioannina
Country [34] 0 0
Greece
State/province [34] 0 0
Larissa
Country [35] 0 0
Greece
State/province [35] 0 0
Patras
Country [36] 0 0
Hungary
State/province [36] 0 0
Györ
Country [37] 0 0
Hungary
State/province [37] 0 0
Kaposvar
Country [38] 0 0
India
State/province [38] 0 0
Ahmedabad
Country [39] 0 0
India
State/province [39] 0 0
Amritsar
Country [40] 0 0
India
State/province [40] 0 0
Aurangabad
Country [41] 0 0
India
State/province [41] 0 0
Bangalore
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India
State/province [42] 0 0
Chennai
Country [43] 0 0
India
State/province [43] 0 0
Hyderabad
Country [44] 0 0
India
State/province [44] 0 0
Kolkata
Country [45] 0 0
India
State/province [45] 0 0
Madurai
Country [46] 0 0
India
State/province [46] 0 0
Mumbai
Country [47] 0 0
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
Country [50] 0 0
India
State/province [50] 0 0
Surat
Country [51] 0 0
India
State/province [51] 0 0
Trivandrum
Country [52] 0 0
India
State/province [52] 0 0
Vellore
Country [53] 0 0
Ireland
State/province [53] 0 0
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
Country [60] 0 0
Italy
State/province [60] 0 0
Meldola
Country [61] 0 0
Italy
State/province [61] 0 0
Milano
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Italy
State/province [62] 0 0
Palermo
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Italy
State/province [63] 0 0
Pavia
Country [64] 0 0
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
Country [69] 0 0
Japan
State/province [69] 0 0
Aomori
Country [70] 0 0
Japan
State/province [70] 0 0
Fukuoka
Country [71] 0 0
Japan
State/province [71] 0 0
Gifu
Country [72] 0 0
Japan
State/province [72] 0 0
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
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Japan
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Matsuyama
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Japan
State/province [77] 0 0
Ogaki
Country [78] 0 0
Japan
State/province [78] 0 0
Okayama
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Japan
State/province [79] 0 0
Omura
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Japan
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Saga
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Japan
State/province [81] 0 0
Tachikawa
Country [82] 0 0
Japan
State/province [82] 0 0
Otake
Country [83] 0 0
Malaysia
State/province [83] 0 0
Alor Setar
Country [84] 0 0
Malaysia
State/province [84] 0 0
Ampang
Country [85] 0 0
Malaysia
State/province [85] 0 0
George Town
Country [86] 0 0
Malaysia
State/province [86] 0 0
Ipoh
Country [87] 0 0
Malaysia
State/province [87] 0 0
Johor Bahru
Country [88] 0 0
Malaysia
State/province [88] 0 0
Klang
Country [89] 0 0
Malaysia
State/province [89] 0 0
Kuala Lumpur
Country [90] 0 0
Malaysia
State/province [90] 0 0
Kuching
Country [91] 0 0
Malaysia
State/province [91] 0 0
Melaka
Country [92] 0 0
Malaysia
State/province [92] 0 0
Pulau Pinang
Country [93] 0 0
Malaysia
State/province [93] 0 0
Subang Jaya
Country [94] 0 0
Netherlands
State/province [94] 0 0
Amsterdam
Country [95] 0 0
Netherlands
State/province [95] 0 0
Delft
Country [96] 0 0
Netherlands
State/province [96] 0 0
Gouda
Country [97] 0 0
Netherlands
State/province [97] 0 0
Heerlen
Country [98] 0 0
Netherlands
State/province [98] 0 0
Rotterdam
Country [99] 0 0
Netherlands
State/province [99] 0 0
Schiedam
Country [100] 0 0
Netherlands
State/province [100] 0 0
Sittard
Country [101] 0 0
Netherlands
State/province [101] 0 0
Zwolle
Country [102] 0 0
Peru
State/province [102] 0 0
Lima
Country [103] 0 0
Poland
State/province [103] 0 0
Brzozow
Country [104] 0 0
Poland
State/province [104] 0 0
Bydgoszcz
Country [105] 0 0
Poland
State/province [105] 0 0
Chorzow
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Poland
State/province [106] 0 0
Krakow
Country [107] 0 0
Poland
State/province [107] 0 0
Lublin
Country [108] 0 0
Poland
State/province [108] 0 0
Warszawa
Country [109] 0 0
Portugal
State/province [109] 0 0
Braga
Country [110] 0 0
Portugal
State/province [110] 0 0
Coimbra
Country [111] 0 0
Portugal
State/province [111] 0 0
Lisboa
Country [112] 0 0
Portugal
State/province [112] 0 0
Porto
Country [113] 0 0
Romania
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Brasov
Country [114] 0 0
Romania
State/province [114] 0 0
Bucharest
Country [115] 0 0
Romania
State/province [115] 0 0
Cluj-Napoca
Country [116] 0 0
Romania
State/province [116] 0 0
Iasi
Country [117] 0 0
Romania
State/province [117] 0 0
Timisoara
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Arkhangelsk
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Chelyabinsk
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Krasnodar
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Russian Federation
State/province [121] 0 0
Kursk
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Russian Federation
State/province [122] 0 0
Moscow
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Nizhniy Novgorod
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Rostov-on -Don
Country [125] 0 0
Russian Federation
State/province [125] 0 0
St. Petersburg
Country [126] 0 0
South Africa
State/province [126] 0 0
Cape Town
Country [127] 0 0
South Africa
State/province [127] 0 0
George
Country [128] 0 0
South Africa
State/province [128] 0 0
Johannesburg
Country [129] 0 0
South Africa
State/province [129] 0 0
Port Elizabeth
Country [130] 0 0
South Africa
State/province [130] 0 0
Pretoria
Country [131] 0 0
Spain
State/province [131] 0 0
Barcelona
Country [132] 0 0
Spain
State/province [132] 0 0
Madrid
Country [133] 0 0
Spain
State/province [133] 0 0
Oviedo
Country [134] 0 0
Spain
State/province [134] 0 0
San Sebastian
Country [135] 0 0
Spain
State/province [135] 0 0
Sevilla
Country [136] 0 0
Spain
State/province [136] 0 0
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
State/province [140] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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