GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

Follicular Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419665
• Other study ID #: GP13-301
• Secondary ID: 2010-019522-13
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2011
• Est. completion date: January 22, 2018

Study information

• Verified date: April 2021
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Other known NCT identifiers

• NCT03814785

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Biological:
• GP2013
Type: Biological/Vaccine
• rituximab
Type: Biological/Vaccine

Locations

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	Investigator 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

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Novartis Pharmaceuticals

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period		24 weeks
Secondary	To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period		24 weeks
Secondary	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	3 years
Secondary	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.	3 years
Secondary	To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)	number of participants with confirmed positive ADA	24 weeks, 3 years
Secondary	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	day 63
Secondary	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	day 63
Secondary	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	21 days