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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
Date last updated
14/05/2021

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
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Argentina
State/province [2] 0 0
Rosario
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Argentina
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San Miguel de Tucuman
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Austria
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Graz
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Austria
State/province [5] 0 0
Wien
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Brazil
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Barretos
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Brazil
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Botucatu
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Florianopolis
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Brazil
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Fortaleza
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Brazil
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Goiania
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Brazil
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Jau
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Sorocaba
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Pleven
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Plovdiv
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Ruse
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Sofia
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Varna
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Medellin
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Monteria
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France
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Colmar
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France
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Nimes
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Strasbourg
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Germany
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Bad Saarow
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Germany
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Koblenz
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Patras
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Hungary
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Györ
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Hungary
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Kaposvar
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India
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Ahmedabad
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India
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Amritsar
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Ashkelon
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Nahariya
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Bari
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Firenze
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Meldola
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Pavia
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Pescara
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Piacenza
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Ravenna
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Okayama
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Omura
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Saga
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Tachikawa
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Otake
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Alor Setar
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Nizhniy Novgorod
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Russian Federation
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Rostov-on -Don
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Russian Federation
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St. Petersburg
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South Africa
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Cape Town
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South Africa
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George
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Johannesburg
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Port Elizabeth
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South Africa
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Pretoria
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Barcelona
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Madrid
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Spain
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Oviedo
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Spain
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San Sebastian
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Spain
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Sevilla
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Spain
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Zaragoza
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Ukraine
State/province [137] 0 0
Cherkasy
Country [138] 0 0
Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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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
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 website
https://clinicaltrials.gov/study/NCT01419665
Trial related presentations / 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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01419665