GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
ASSIST_FL
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
2 other identifiers
interventional
629
25 countries
148
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
Longer than P75 for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2011
CompletedFirst Posted
Study publicly available on registry
August 18, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2018
CompletedResults Posted
Study results publicly available
May 14, 2021
CompletedMay 14, 2021
April 1, 2021
3.6 years
August 17, 2011
March 5, 2019
April 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
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.
24 weeks
Secondary Outcomes (8)
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
24 weeks
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
24 weeks
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
3 years
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
3 years
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
24 weeks, 3 years
- +3 more secondary outcomes
Study Arms (2)
GP2013
EXPERIMENTALType: Biological/Vaccine
rituximab
ACTIVE COMPARATORType: Biological/Vaccine
Interventions
Eligibility Criteria
You may qualify if:
- Patient with previously untreated advanced stage, CD20-positive FL
- Patient with ECOG performance status 0, 1 or 2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
- Novartis Pharmaceuticalscollaborator
Study Sites (153)
Investigative site
La Plata, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Adelaide, Australia
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Ballarat, Australia
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Epping, Australia
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Footscray, Australia
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Wodonga, Australia
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Graz, Austria
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Vienna, Austria
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Barretos, Brazil
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Barretos, Brazil
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Botucatu, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Fortaleza, Brazil
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Goiânia, Brazil
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Jaú, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Sorocaba, Brazil
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Medellín, Colombia
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Montería, Colombia
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Colmar, France
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Nîmes, France
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Strasbourg, France
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Bad Saarow, Germany
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Koblenz, Germany
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Athens, Greece
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Ioannina, Greece
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Larissa, Greece
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Pátrai, Greece
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Győr, Hungary
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Kaposvár, Hungary
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Ahmedabad, India
India
Amritsar, India
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Aurangabad, India
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Bangalore, India
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Chennai, India
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Hyderabad, India
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Kolkata, India
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Kolkata, India
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Madurai, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Pune, India
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Surat, India
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Trivandrum, India
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Vellore, India
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Dublin, Ireland
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Limerick, Ireland
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Waterford, Ireland
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Ashkelon, Israel
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Nahariya, Israel
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Bari, Italy
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Florence, Italy
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Meldola, Italy
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Milan, Italy
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Palermo, Italy
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Pavia, Italy
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Pescara, Italy
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Piacenza, Italy
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Ravenna, Italy
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Reggio Calabria, Italy
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Varese, Italy
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Aomori, Japan
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Fukuoka, Japan
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Gifu, Japan
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Kagoshima, Japan
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Kitakyushu, Japan
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Kobe, Japan
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Komaki, Japan
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Matsuyama, Japan
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Okayama, Japan
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Ōgaki, Japan
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Ōmura, Japan
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Ōtake, Japan
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Saga, Japan
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Tachikawa, Japan
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Alor Star, Malaysia
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Ampang, Malaysia
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George Town, Malaysia
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Ipoh, Malaysia
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Johor Bahru, Malaysia
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Klang, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Malacca, Malaysia
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Pulau Pinang, Malaysia
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Subang Jaya, Malaysia
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Amsterdam, Netherlands
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Delft, Netherlands
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Gouda, Netherlands
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Heerlen, Netherlands
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Rotterdam, Netherlands
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Schiedam, Netherlands
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Sittard, Netherlands
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Zwolle, Netherlands
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Lima, Peru
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Brzozów, Poland
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Bydgoszcz, Poland
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Chorzów, Poland
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Krakow, Poland
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Lublin, Poland
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Warsaw, Poland
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Krasnodar, Russia
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Kursk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Rostov-on-Don, Russia
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Saint Petersburg, Russia
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Cape Town, South Africa
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George, South Africa
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Johannesburg, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Barcelona, Spain
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Donostia / San Sebastian, Spain
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Madrid, Spain
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Oviedo, Spain
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Seville, Spain
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Zaragoza, Spain
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Cherkasy, Ukraine
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Eastbourne, United Kingdom
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London, United Kingdom
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Worthing, United Kingdom
Related Publications (1)
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.
PMID: 28712941DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Hexal AG / Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2011
First Posted
August 18, 2011
Study Start
December 1, 2011
Primary Completion
July 10, 2015
Study Completion
January 22, 2018
Last Updated
May 14, 2021
Results First Posted
May 14, 2021
Record last verified: 2021-04