Follicular Lymphoma Clinical Trial
— ASSIST_FLOfficial 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
| Verified date | January 2019 |
| Source | Sandoz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 629 |
| Est. completion date | January 22, 2018 |
| Est. primary completion date | July 10, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient with previously untreated advanced stage, CD20-positive FL - Patient with ECOG performance status 0, 1 or 2. 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Investigative site | La Plata | |
| Argentina | Investigative site | Rosario | |
| Argentina | Investigative site | San Miguel de Tucuman | |
| Australia | Investigative site | Adelaide | |
| Australia | Investigative site | Ballarat | |
| Australia | Investigative site | Epping | |
| Australia | Investigative site | Footscray | |
| Australia | Investigative site | Wodonga | |
| Austria | Investigative site | Graz | |
| Austria | Investigative site | Wien | |
| Brazil | Investigative site | Barretos | |
| Brazil | Investigative site | Botucatu | |
| Brazil | Investigative site | Campinas | |
| Brazil | Investigative site | Curitiba | |
| Brazil | Investigative site | Florianopolis | |
| Brazil | Investigative site | Fortaleza | |
| Brazil | Investigative site | Goiania | |
| Brazil | Investigative site | Jau | |
| Brazil | Investigative site | Passo Fundo | |
| Brazil | Investigative site | Porto Alegre | |
| Brazil | Investigative Site | Rio de Janeiro | |
| Brazil | Investigative site | Santo Andre | |
| Brazil | Investigative site | Sao Paulo | |
| Brazil | Investigative site | Sorocaba | |
| Bulgaria | Investigative site | Pleven | |
| Bulgaria | Investigative site | Plovdiv | |
| Bulgaria | Investigative site | Ruse | |
| Bulgaria | Investigative site | Sofia | |
| Bulgaria | Investigative site | Varna | |
| Colombia | Investigative site | Medellin | |
| Colombia | Investigative site | Monteria | |
| France | Investigative site | Colmar | |
| France | Investigative site | Nimes | |
| France | Investigative site | Strasbourg | |
| Germany | Investigative site | Bad Saarow | |
| Germany | Investigative site | Koblenz | |
| Greece | Investigative site | Athens | |
| Greece | Investigative site | Ioannina | |
| Greece | Investigative site | Larissa | |
| Greece | Investigative site | Patras | |
| Hungary | Investigative site | Györ | |
| Hungary | Investigative site | Kaposvar | |
| India | 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 | |
| Ireland | Investigative site | Dublin | |
| Ireland | Investigative site | Limerick | |
| Ireland | Investigative site | Waterford | |
| Israel | Investigative site | Ashkelon | |
| Israel | Investigative site | Nahariya | |
| Italy | Investigative site | Bari | |
| Italy | Investigative site | Firenze | |
| Italy | Investigative site | Meldola | |
| Italy | Investigative site | Milano | |
| 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 | |
| Japan | 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 | Ogaki | |
| Japan | Investigative site | Okayama | |
| Japan | Invstigative site | Omura | |
| Japan | Investigative site | Otake | |
| Japan | Investigative site | Saga | |
| Japan | Investigative site | Tachikawa | |
| Malaysia | Investigative site | Alor Setar | |
| 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 | Melaka | |
| Malaysia | Investigative site | Pulau Pinang | |
| Malaysia | Investigative site | Subang Jaya | |
| Netherlands | 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 | |
| Peru | Investigative site | Lima | |
| Poland | Investigative site | Brzozow | |
| Poland | Investigative site | Bydgoszcz | |
| Poland | Investigative site | Chorzow | |
| Poland | Investigative site | Krakow | |
| Poland | Investigative site | Lublin | |
| Poland | Investigative site | Warszawa | |
| Portugal | Investigative site | Braga | |
| Portugal | Investigative site | Coimbra | |
| Portugal | Investigative site | Lisboa | |
| Portugal | Investigative site | Porto | |
| Romania | Investigative site | Brasov | |
| Romania | Investigative site | Bucharest | |
| Romania | Investigative site | Cluj-Napoca | |
| Romania | Investigative site | Iasi | |
| Romania | Investigative site | Timisoara | |
| Russian Federation | Investigative site | Arkhangelsk | |
| Russian Federation | Investigative site | Chelyabinsk | |
| Russian Federation | Investigative site | Krasnodar | |
| Russian Federation | Investigative site | Kursk | |
| Russian Federation | Investigative site | Moscow | |
| Russian Federation | Investigative site | Nizhniy Novgorod | |
| Russian Federation | Investigative site | Rostov-on -Don | |
| Russian Federation | Investigative site | St. Petersburg | |
| South Africa | 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 | |
| Spain | Investigative site | Barcelona | |
| Spain | Investigative site | Madrid | |
| Spain | Investigative site | Oviedo | |
| Spain | Investigative site | San Sebastian | |
| Spain | Investigative site | Sevilla | |
| Spain | Investigative site | Zaragoza | |
| Ukraine | 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 | |
| United Kingdom | Investigative site | Eastbourne | |
| United Kingdom | Investigative site | London | |
| United Kingdom | Investigative site | Worthing |
| Lead Sponsor | Collaborator |
|---|---|
| Sandoz | Novartis Pharmaceuticals |
Argentina, Australia, Austria, Brazil, Bulgaria, Colombia, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate in patients with FL | Overall response rate | 24 weeks | |
| Secondary | Percentage of patients with Adverse Events (AEs) | up to 2 years |
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