Follicular LymphomaPhase 3ASSIST_FLNCT01419665
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
A Phase 3 study testing GP2013 and rituximab in people with Follicular Lymphoma, run by Sandoz at 153 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- GP2013 and rituximab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- 153 sitesin 26 countries
- Study dates
- 1 Dec 2011to 22 Jan 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with previously untreated advanced stage, CD20-positive FL
- Patient with ECOG performance status 0, 1 or 2.
Who cannot join
- 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
Trial locations and contacts
153 sites in 26 countries.
153 sites in 26 countries
India16 sites
Investigative site
Ahmedabad
India
Amritsar
Investigative site
Bangalore
Investigative site
Chennai
Investigative site
Chhatrapati Sambhajinagar
Investigative site
Hyderabad
Investigative site
Kolkata
Investigtive site
Kolkata
Investigative site
Madurai
Investigative site
Mumbai
Investigative site
Nashik
Investigative site
New Delhi
Investigative site
Pune
Investigative site
Surat
Investigative site
Trivandrum
Investigative site
Vellore
Brazil15 sites
Investigative site
Barretos
Investigator site
Barretos
Investigative site
Botucatu
Investigative site
Campinas
Investigative site
Curitiba
Investigative site
Florianópolis
Investigative site
Fortaleza
Investigative site
Goiânia
Investigative site
Jaú
Investigative site
Passo Fundo
Investigative site
Porto Alegre
Investigative Site
Rio de Janeiro
Investigative site
Santo André
Investigative site
São Paulo
Investigative site
Sorocaba
Japan14 sites
Investigative site
Aomori
Investigative site
Fukuoka
Investigative site
Gifu
Investigative site
Kagoshima
Investigative site
Kitakyushu
Investigative site
Kobe
Investigative site
Komaki
Investigative site
Matsuyama
Investigative site
Ōgaki
Investigative site
Okayama
Invstigative site
Ōmura
Investigative site
Ōtake
Investigative site
Saga
Investigative site
Tachikawa
Italy11 sites
Investigative site
Bari
Investigative site
Florence
Investigative site
Meldola
Investigative site
Milan
Investigative site
Palermo
Investigative site
Pavia
Investigative site
Pescara
Investigative site
Piacenza
Investigative site
Ravenna
Investigative site
Reggio Calabria
Investigative site
Varese
Malaysia11 sites
Investigative site
Alor Star
Investigative site
Ampang
Investigative site
George Town
Investigative site
Ipoh
Investigative site
Johor Bahru
Investigative site
Klang
Investigative site
Kuala Lumpur
Investigative site
Kuching
Investigative site
Malacca
Investigative site
Pulau Pinang
Investigative site
Subang Jaya
Netherlands8 sites
Investigative site
Amsterdam
Investigative site
Delft
Investigative site
Gouda
Investigative site
Heerlen
Investigative site
Rotterdam
Investigative site
Schiedam
Investigative site
Sittard
Investigative site
Zwolle
Russia8 sites
Investigative site
Arkhangelsk
Investigative site
Chelyabinsk
Investigative site
Krasnodar
Investigative site
Kursk
Investigative site
Moscow
Investigative site
Nizhny Novgorod
Investigative site
Rostov-on-Don
Investigative site
Saint Petersburg
Ukraine7 sites
Investigative site
Cherkasy
Investigative site
Dnipropetrovsk
Investigative site
Donetsk
Investigative site
Ivano-Frankivsk
Investigative site
Kharkiv
Investigative site
Kyiv
Investigative site
Lviv
Poland6 sites
Investigative site
Brzozów
Investigative site
Bydgoszcz
Investigative site
Chorzów
Investigative site
Krakow
Investigative site
Lublin
Investigative site
Warsaw
Spain6 sites
Investigative site
Barcelona
Investigative site
Donostia / San Sebastian
Investigative site
Madrid
Investigative site
Oviedo
Investigative site
Seville
Investigative site
Zaragoza
Australia5 sites
Investigative site
Adelaide
Investigative site
Ballarat
Investigative site
Epping
Investigative site
Footscray
Investigative site
Wodonga
Bulgaria5 sites
Investigative site
Pleven
Investigative site
Plovdiv
Investigative site
Rousse
Investigative site
Sofia
Investigative site
Varna
Romania5 sites
Investigative site
Brasov
Investigative site
Bucharest
Investigative site
Cluj-Napoca
Investigative site
Iași
Investigative site
Timișoara
South Africa5 sites
Investigative site
Cape Town
Investigative site
George
Investigative site
Johannesburg
Investigative site
Port Elizabeth
Investigative site
Pretoria
Greece4 sites
Investigative site
Athens
Investigative site
Ioannina
Investigative site
Larissa
Investigative site
Pátrai
Portugal4 sites
Investigative site
Braga
Investigative site
Coimbra
Investigative site
Lisbon
Investigative site
Porto
Argentina3 sites
Investigative site
La Plata
Investigative site
Rosario
Investigative site
San Miguel de Tucumán
France3 sites
Investigative site
Colmar
Investigative site
Nîmes
Investigative site
Strasbourg
Ireland3 sites
Investigative site
Dublin
Investigative site
Limerick
Investigative site
Waterford
United Kingdom3 sites
Investigative site
Eastbourne
Investigative site
London
Investigative site
Worthing
About this study
Official 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
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.
- Conditions
- Follicular Lymphoma
- Being tested
- GP2013, rituximab
- Keywords
- Follicular Lymphoma, Biosimilar, GP13-301, rituximab, Antibodies, CD20
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP2013Biological
Also called no brand name available
Type: Biological/Vaccine
rituximabBiological
Also called MabThera(R)
Type: Biological/Vaccine
| Study group | Role | What they receive |
|---|---|---|
| GP2013 | Experimental | Type: Biological/Vaccine Receives: Biological: GP2013 |
| rituximab | Active comparator | Type: Biological/Vaccine Receives: Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (8)
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Measured: 24 weeks
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Measured: 24 weeks
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Number of participants with progression free survival events
Measured: 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
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.
Measured: 3 years
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
number of participants with confirmed positive ADA
Measured: 24 weeks, 3 years
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
C max
For descriptive purposes only, no hypothesis testing
Measured: day 63
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
C through
For descriptive purposes only, no hypothesis testing
Measured: day 63
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
AUEC (0-21d)
For descriptive purposes only, no hypothesis testing
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study start1 Dec 2011
- Primary completion10 Jul 2015
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A subset of patients is switched from GP2013 to MabThera or continued with MabThera during the maintenance phase, for these patients the treatment is finished as an open labeled parallel arm study. The original treatment assignment is kept blinded.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419665
- Sponsor's protocol ID
- GP13-301
- Other IDs
- 2010-019522-13
- Acronym
- ASSIST_FL
- Status last verified
- Apr 2021
- First submitted
- 17 Aug 2011
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 28712941
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01419665
- Acronym / sponsor ID
- ASSIST_FL / GP13-301
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular Lymphoma, Biosimilar, GP13-301, rituximab, Antibodies, CD20
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 10 Jul 2015 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A subset of patients is switched from GP2013 to MabThera or continued with MabThera during the maintenance phase, for these patients the treatment is finished as an open labeled parallel arm study. The original treatment assignment is kept blinded.
| Arm | Type | Receives |
|---|---|---|
| GP2013 | Experimental | Biological: GP2013Type: Biological/Vaccine |
| rituximab | Active comparator | Biological: rituximabType: Biological/Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with previously untreated advanced stage, CD20-positive FL
- Patient with ECOG performance status 0, 1 or 2.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP2013Also: no brand name availableType: Biological/Vaccine | Biological | GP2013 |
| rituximabAlso: MabThera(R)Type: Biological/Vaccine | Biological | rituximab |
Primary outcome
Overall Response Rate (ORR)
Time frame: 24 weeks
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.
8 secondary outcomes
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Time frame: 24 weeks
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Time frame: 24 weeks
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Time frame: 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
Time frame: 3 years
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
Time frame: 24 weeks, 3 years
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
Time frame: day 63
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
Time frame: day 63
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28712941Jurczak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
153 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GP2013 and rituximab in people with Follicular Lymphoma, run by Sandoz at 153 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 153 sites in India, Brazil, Japan, Italy, Malaysia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.