Clinical trial NCT01419665: GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Lymphoma
Keywords: Follicular Lymphoma
Biosimilar
GP13-301
rituximab
Antibodies
CD20
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-08-18
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 24 weeks
Secondary outcomes:
measure: To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
timeFrame: 24 weeks
measure: To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
timeFrame: 24 weeks
measure: To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
timeFrame: 3 years
measure: To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
timeFrame: 3 years
measure: To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
timeFrame: 24 weeks, 3 years
measure: To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
timeFrame: day 63
measure: To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
timeFrame: day 63
measure: To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
timeFrame: 21 days
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Investigative site
city: Rosario
country: Argentina
facility: Investigative site
city: San Miguel de Tucuman
country: Argentina
facility: Investigative site
city: Adelaide
country: Australia
facility: Investigative site
city: Ballarat
country: Australia
facility: Investigative site
city: Epping
country: Australia
facility: Investigative site
city: Footscray
country: Australia
facility: Investigative site
city: Wodonga
country: Australia
facility: Investigative site
city: Graz
country: Austria
facility: Investigative site
city: Wien
country: Austria
facility: Investigative site
city: Barretos
country: Brazil
facility: Investigative site
city: Barretos
country: Brazil
facility: Investigator site
city: Botucatu
country: Brazil
facility: Investigative site
city: Campinas
country: Brazil
facility: Investigative site
city: Curitiba
country: Brazil
facility: Investigative site
city: Florianopolis
country: Brazil
facility: Investigative site
city: Fortaleza
country: Brazil
facility: Investigative site
city: Goiania
country: Brazil
facility: Investigative site
city: Jau
country: Brazil
facility: Investigative site
city: Passo Fundo
country: Brazil
facility: Investigative site
city: Porto Alegre
country: Brazil
facility: Investigative site
city: Rio de Janeiro
country: Brazil
facility: Investigative Site
city: Santo Andre
country: Brazil
facility: Investigative site
city: Sao Paulo
country: Brazil
facility: Investigative site
city: Sorocaba
country: Brazil
facility: Investigative site
city: Pleven
country: Bulgaria
facility: Investigative site
city: Plovdiv
country: Bulgaria
facility: Investigative site
city: Ruse
country: Bulgaria
facility: Investigative site
city: Sofia
country: Bulgaria
facility: Investigative site
city: Varna
country: Bulgaria
facility: Investigative site
city: Medellin
country: Colombia
facility: Investigative site
city: Monteria
country: Colombia
facility: Investigative site
city: Colmar
country: France
facility: Investigative site
city: Nimes
country: France
facility: Investigative site
city: Strasbourg
country: France
facility: Investigative site
city: Bad Saarow
country: Germany
facility: Investigative site
city: Koblenz
country: Germany
facility: Investigative site
city: Athens
country: Greece
facility: Investigative site
city: Ioannina
country: Greece
facility: Investigative site
city: Larissa
country: Greece
facility: Investigative site
city: Patras
country: Greece
facility: Investigative site
city: Györ
country: Hungary
facility: Investigative site
city: Kaposvar
country: Hungary
facility: Investigative site
city: Ahmedabad
country: India
facility: Investigative site
city: Amritsar
country: India
facility: India
city: Aurangabad
country: India
facility: Investigative site
city: Bangalore
country: India
facility: Investigative site
city: Chennai
country: India
facility: Investigative site
city: Hyderabad
country: India
facility: Investigative site
city: Kolkata
country: India
facility: Investigative site
city: Kolkata
country: India
facility: Investigtive site
city: Madurai
country: India
facility: Investigative site
city: Mumbai
country: India
facility: Investigative site
city: Nashik
country: India
facility: Investigative site
city: New Delhi
country: India
facility: Investigative site
city: Pune
country: India
facility: Investigative site
city: Surat
country: India
facility: Investigative site
city: Trivandrum
country: India
facility: Investigative site
city: Vellore
country: India
facility: Investigative site
city: Dublin
country: Ireland
facility: Investigative site
city: Limerick
country: Ireland
facility: Investigative site
city: Waterford
country: Ireland
facility: Investigative site
city: Ashkelon
country: Israel
facility: Investigative site
city: Nahariya
country: Israel
facility: Investigative site
city: Bari
country: Italy
facility: Investigative site
city: Firenze
country: Italy
facility: Investigative site
city: Meldola
country: Italy
facility: Investigative site
city: Milano
country: Italy
facility: Investigative site
city: Palermo
country: Italy
facility: Investigative site
city: Pavia
country: Italy
facility: Investigative site
city: Pescara
country: Italy
facility: Investigative site
city: Piacenza
country: Italy
facility: Investigative site
city: Ravenna
country: Italy
facility: Investigative site
city: Reggio Calabria
country: Italy
facility: Investigative site
city: Varese
country: Italy
facility: Investigative site
city: Aomori
country: Japan
facility: Investigative site
city: Fukuoka
country: Japan
facility: Investigative site
city: Gifu
country: Japan
facility: Investigative site
city: Kagoshima
country: Japan
facility: Investigative site
city: Kitakyushu
country: Japan
facility: Investigative site
city: Kobe
country: Japan
facility: Investigative site
city: Komaki
country: Japan
facility: Investigative site
city: Matsuyama
country: Japan
facility: Investigative site
city: Ogaki
country: Japan
facility: Investigative site
city: Okayama
country: Japan
facility: Investigative site
city: Omura
country: Japan
facility: Invstigative site
city: Saga
country: Japan
facility: Investigative site
city: Tachikawa
country: Japan
facility: Investigative site
city: Ōtake
country: Japan
facility: Investigative site
city: Alor Setar
country: Malaysia
facility: Investigative site
city: Ampang
country: Malaysia
facility: Investigative site
city: George Town
country: Malaysia
facility: Investigative site
city: Ipoh
country: Malaysia
facility: Investigative site
city: Johor Bahru
country: Malaysia
facility: Investigative site
city: Klang
country: Malaysia
facility: Investigative site
city: Kuala Lumpur
country: Malaysia
facility: Investigative site
city: Kuching
country: Malaysia
facility: Investigative site
city: Melaka
country: Malaysia
facility: Investigative site
city: Pulau Pinang
country: Malaysia
facility: Investigative site
city: Subang Jaya
country: Malaysia
facility: Investigative site
city: Amsterdam
country: Netherlands
facility: Investigative site
city: Delft
country: Netherlands
facility: Investigative site
city: Gouda
country: Netherlands
facility: Investigative site
city: Heerlen
country: Netherlands
facility: Investigative site
city: Rotterdam
country: Netherlands
facility: Investigative site
city: Schiedam
country: Netherlands
facility: Investigative site
city: Sittard
country: Netherlands
facility: Investigative site
city: Zwolle
country: Netherlands
facility: Investigative site
city: Lima
country: Peru
facility: Investigative site
city: Brzozow
country: Poland
facility: Investigative site
city: Bydgoszcz
country: Poland
facility: Investigative site
city: Chorzow
country: Poland
facility: Investigative site
city: Krakow
country: Poland
facility: Investigative site
city: Lublin
country: Poland
facility: Investigative site
city: Warszawa
country: Poland
facility: Investigative site
city: Braga
country: Portugal
facility: Investigative site
city: Coimbra
country: Portugal
facility: Investigative site
city: Lisboa
country: Portugal
facility: Investigative site
city: Porto
country: Portugal
facility: Investigative site
city: Brasov
country: Romania
facility: Investigative site
city: Bucharest
country: Romania
facility: Investigative site
city: Cluj-Napoca
country: Romania
facility: Investigative site
city: Iasi
country: Romania
facility: Investigative site
city: Timisoara
country: Romania
facility: Investigative site
city: Arkhangelsk
country: Russian Federation
facility: Investigative site
city: Chelyabinsk
country: Russian Federation
facility: Investigative site
city: Krasnodar
country: Russian Federation
facility: Investigative site
city: Kursk
country: Russian Federation
facility: Investigative site
city: Moscow
country: Russian Federation
facility: Investigative site
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigative site
city: Rostov-on -Don
country: Russian Federation
facility: Investigative site
city: St. Petersburg
country: Russian Federation
facility: Investigative site
city: Cape Town
country: South Africa
facility: Investigative site
city: George
country: South Africa
facility: Investigative site
city: Johannesburg
country: South Africa
facility: Investigative site
city: Port Elizabeth
country: South Africa
facility: Investigative site
city: Pretoria
country: South Africa
facility: Investigative site
city: Barcelona
country: Spain
facility: Investigative site
city: Madrid
country: Spain
facility: Investigative site
city: Oviedo
country: Spain
facility: Investigative site
city: San Sebastian
country: Spain
facility: Investigative site
city: Sevilla
country: Spain
facility: Investigative site
city: Zaragoza
country: Spain
facility: Investigative site
city: Cherkasy
country: Ukraine
facility: Investigative site
city: Dnipropetrovsk
country: Ukraine
facility: Investigative site
city: Donetsk
country: Ukraine
facility: Investigative site
city: Ivano-Frankivsk
country: Ukraine
facility: Investigative site
city: Kharkiv
country: Ukraine
facility: Investigative site
city: Kyiv
country: Ukraine
facility: Investigative site
city: Lviv
country: Ukraine
facility: Investigative site
city: Eastbourne
country: United Kingdom
facility: Investigative site
city: London
country: United Kingdom
facility: Investigative site
city: Worthing
country: United Kingdom
facility: Investigative site
Study officials:
References:
citation: 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.