GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
NCT ID: NCT01419665
Last Updated: 2021-05-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
629 participants
INTERVENTIONAL
2011-12-01
2018-01-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
NCT02213263
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
NCT01200758
Primary Rituximab and Maintenance
NCT00140582
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma
NCT00115700
Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy
NCT04962126
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GP2013
Type: Biological/Vaccine
GP2013
Type: Biological/Vaccine
rituximab
Type: Biological/Vaccine
rituximab
Type: Biological/Vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GP2013
Type: Biological/Vaccine
rituximab
Type: Biological/Vaccine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient with ECOG performance status 0, 1 or 2.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Sandoz
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative site
La Plata, , Argentina
Investigative site
Rosario, , Argentina
Investigative site
San Miguel de Tucumán, , Argentina
Investigative site
Adelaide, , Australia
Investigative site
Ballarat, , Australia
Investigative site
Epping, , Australia
Investigative site
Footscray, , Australia
Investigative site
Wodonga, , Australia
Investigative site
Graz, , Austria
Investigative site
Vienna, , Austria
Investigative site
Barretos, , Brazil
Investigator site
Barretos, , Brazil
Investigative site
Botucatu, , Brazil
Investigative site
Campinas, , Brazil
Investigative site
Curitiba, , Brazil
Investigative site
Florianópolis, , Brazil
Investigative site
Fortaleza, , Brazil
Investigative site
Goiânia, , Brazil
Investigative site
Jaú, , Brazil
Investigative site
Passo Fundo, , Brazil
Investigative site
Porto Alegre, , Brazil
Investigative Site
Rio de Janeiro, , Brazil
Investigative site
Santo André, , Brazil
Investigative site
São Paulo, , Brazil
Investigative site
Sorocaba, , Brazil
Investigative site
Pleven, , Bulgaria
Investigative site
Plovdiv, , Bulgaria
Investigative site
Rousse, , Bulgaria
Investigative site
Sofia, , Bulgaria
Investigative site
Varna, , Bulgaria
Investigative site
Medellín, , Colombia
Investigative site
Montería, , Colombia
Investigative site
Colmar, , France
Investigative site
Nîmes, , France
Investigative site
Strasbourg, , France
Investigative site
Bad Saarow, , Germany
Investigative site
Koblenz, , Germany
Investigative site
Athens, , Greece
Investigative site
Ioannina, , Greece
Investigative site
Larissa, , Greece
Investigative site
Pátrai, , Greece
Investigative site
Győr, , Hungary
Investigative site
Kaposvár, , Hungary
Investigative site
Ahmedabad, , India
India
Amritsar, , India
Investigative site
Aurangabad, , India
Investigative site
Bangalore, , India
Investigative site
Chennai, , India
Investigative site
Hyderabad, , India
Investigative site
Kolkata, , India
Investigtive site
Kolkata, , India
Investigative site
Madurai, , India
Investigative site
Mumbai, , India
Investigative site
Nashik, , India
Investigative site
New Delhi, , India
Investigative site
Pune, , India
Investigative site
Surat, , India
Investigative site
Trivandrum, , India
Investigative site
Vellore, , India
Investigative site
Dublin, , Ireland
Investigative site
Limerick, , Ireland
Investigative site
Waterford, , Ireland
Investigative site
Ashkelon, , Israel
Investigative site
Nahariya, , Israel
Investigative site
Bari, , Italy
Investigative site
Florence, , Italy
Investigative site
Meldola, , Italy
Investigative site
Milan, , Italy
Investigative site
Palermo, , Italy
Investigative site
Pavia, , Italy
Investigative site
Pescara, , Italy
Investigative site
Piacenza, , Italy
Investigative site
Ravenna, , Italy
Investigative site
Reggio Calabria, , Italy
Investigative site
Varese, , Italy
Investigative site
Aomori, , Japan
Investigative site
Fukuoka, , Japan
Investigative site
Gifu, , Japan
Investigative site
Kagoshima, , Japan
Investigative site
Kitakyushu, , Japan
Investigative site
Kobe, , Japan
Investigative site
Komaki, , Japan
Investigative site
Matsuyama, , Japan
Investigative site
Okayama, , Japan
Investigative site
Ōgaki, , Japan
Invstigative site
Ōmura, , Japan
Investigative site
Ōtake, , Japan
Investigative site
Saga, , Japan
Investigative site
Tachikawa, , Japan
Investigative site
Alor Star, , Malaysia
Investigative site
Ampang, , Malaysia
Investigative site
George Town, , Malaysia
Investigative site
Ipoh, , Malaysia
Investigative site
Johor Bahru, , Malaysia
Investigative site
Klang, , Malaysia
Investigative site
Kuala Lumpur, , Malaysia
Investigative site
Kuching, , Malaysia
Investigative site
Malacca, , Malaysia
Investigative site
Pulau Pinang, , Malaysia
Investigative site
Subang Jaya, , Malaysia
Investigative site
Amsterdam, , Netherlands
Investigative site
Delft, , Netherlands
Investigative site
Gouda, , Netherlands
Investigative site
Heerlen, , Netherlands
Investigative site
Rotterdam, , Netherlands
Investigative site
Schiedam, , Netherlands
Investigative site
Sittard, , Netherlands
Investigative site
Zwolle, , Netherlands
Investigative site
Lima, , Peru
Investigative site
Brzozów, , Poland
Investigative site
Bydgoszcz, , Poland
Investigative site
Chorzów, , Poland
Investigative site
Krakow, , Poland
Investigative site
Lublin, , Poland
Investigative site
Warsaw, , Poland
Investigative site
Braga, , Portugal
Investigative site
Coimbra, , Portugal
Investigative site
Lisbon, , Portugal
Investigative site
Porto, , Portugal
Investigative site
Brasov, , Romania
Investigative site
Bucharest, , Romania
Investigative site
Cluj-Napoca, , Romania
Investigative site
Iași, , Romania
Investigative site
Timișoara, , Romania
Investigative site
Arkhangelsk, , Russia
Investigative site
Chelyabinsk, , Russia
Investigative site
Krasnodar, , Russia
Investigative site
Kursk, , Russia
Investigative site
Moscow, , Russia
Investigative site
Nizhny Novgorod, , Russia
Investigative site
Rostov-on-Don, , Russia
Investigative site
Saint Petersburg, , Russia
Investigative site
Cape Town, , South Africa
Investigative site
George, , South Africa
Investigative site
Johannesburg, , South Africa
Investigative site
Port Elizabeth, , South Africa
Investigative site
Pretoria, , South Africa
Investigative site
Barcelona, , Spain
Investigative site
Donostia / San Sebastian, , Spain
Investigative site
Madrid, , Spain
Investigative site
Oviedo, , Spain
Investigative site
Seville, , Spain
Investigative site
Zaragoza, , Spain
Investigative site
Cherkasy, , Ukraine
Investigative site
Dnipropetrovsk, , Ukraine
Investigative site
Donetsk, , Ukraine
Investigative site
Ivano-Frankivsk, , Ukraine
Investigative site
Kharkiv, , Ukraine
Investigative site
Kyiv, , Ukraine
Investigative site
Lviv, , Ukraine
Investigative site
Eastbourne, , United Kingdom
Investigative site
London, , United Kingdom
Investigative site
Worthing, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-019522-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GP13-301
Identifier Type: -
Identifier Source: org_study_id
NCT03814785
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.