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

April 22, 2021 updated by: Sandoz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

629

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • La Plata, Argentina
        • Investigative Site
      • Rosario, Argentina
        • Investigative Site
      • San Miguel de Tucuman, Argentina
        • Investigative Site
  • Australia
      • Adelaide, Australia
        • Investigative Site
      • Ballarat, Australia
        • Investigative Site
      • Epping, Australia
        • Investigative Site
      • Footscray, Australia
        • Investigative Site
      • Wodonga, Australia
        • Investigative Site
  • Austria
      • Graz, Austria
        • Investigative Site
      • Wien, Austria
        • Investigative Site
  • Brazil
      • Barretos, Brazil
        • Investigative Site
      • Barretos, Brazil
        • Investigator 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, Brazil
        • Investigative Site
  • Bulgaria
      • Pleven, Bulgaria
        • Investigative Site
      • Plovdiv, Bulgaria
        • Investigative Site
      • Ruse, Bulgaria
        • Investigative Site
      • Sofia, Bulgaria
        • Investigative Site
      • Varna, Bulgaria
        • Investigative Site
  • Colombia
      • Medellin, Colombia
        • Investigative Site
      • Monteria, Colombia
        • Investigative Site
  • France
      • Colmar, France
        • Investigative Site
      • Nimes, France
        • Investigative Site
      • Strasbourg, France
        • Investigative Site
  • Germany
      • Bad Saarow, Germany
        • Investigative Site
      • Koblenz, Germany
        • Investigative Site
  • Greece
      • Athens, Greece
        • Investigative Site
      • Ioannina, Greece
        • Investigative Site
      • Larissa, Greece
        • Investigative Site
      • Patras, Greece
        • Investigative Site
  • Hungary
      • Györ, Hungary
        • Investigative Site
      • Kaposvar, Hungary
        • Investigative Site
  • India
      • Ahmedabad, India
        • Investigative Site
      • Amritsar, India
        • India
      • Aurangabad, India
        • Investigative Site
      • Bangalore, India
        • Investigative Site
      • Chennai, India
        • Investigative Site
      • Hyderabad, India
        • Investigative Site
      • Kolkata, India
        • Investigative Site
      • Kolkata, India
        • Investigtive 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, India
        • Investigative Site
  • Ireland
      • Dublin, Ireland
        • Investigative Site
      • Limerick, Ireland
        • Investigative Site
      • Waterford, Ireland
        • Investigative Site
  • Israel
      • Ashkelon, Israel
        • Investigative Site
      • Nahariya, Israel
        • Investigative Site
  • Italy
      • 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, Italy
        • Investigative Site
  • Japan
      • 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
        • Investigative Site
      • Omura, Japan
        • Invstigative site
      • Saga, Japan
        • Investigative Site
      • Tachikawa, Japan
        • Investigative Site
      • Ōtake, Japan
        • Investigative Site
  • Malaysia
      • 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, Malaysia
        • Investigative Site
  • Netherlands
      • 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, Netherlands
        • Investigative Site
  • Peru
      • Lima, Peru
        • Investigative Site
  • Poland
      • Brzozow, Poland
        • Investigative Site
      • Bydgoszcz, Poland
        • Investigative Site
      • Chorzow, Poland
        • Investigative Site
      • Krakow, Poland
        • Investigative Site
      • Lublin, Poland
        • Investigative Site
      • Warszawa, Poland
        • Investigative Site
  • Portugal
      • Braga, Portugal
        • Investigative Site
      • Coimbra, Portugal
        • Investigative Site
      • Lisboa, Portugal
        • Investigative Site
      • Porto, Portugal
        • Investigative Site
  • Romania
      • Brasov, Romania
        • Investigative Site
      • Bucharest, Romania
        • Investigative Site
      • Cluj-Napoca, Romania
        • Investigative Site
      • Iasi, Romania
        • Investigative Site
      • Timisoara, Romania
        • Investigative Site
  • Russian Federation
      • 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, Russian Federation
        • Investigative Site
  • South Africa
      • Cape Town, South Africa
        • Investigative Site
      • George, South Africa
        • Investigative Site
      • Johannesburg, South Africa
        • Investigative Site
      • Port Elizabeth, South Africa
        • Investigative Site
      • Pretoria, South Africa
        • Investigative Site
  • Spain
      • Barcelona, Spain
        • Investigative Site
      • Madrid, Spain
        • Investigative Site
      • Oviedo, Spain
        • Investigative Site
      • San Sebastian, Spain
        • Investigative Site
      • Sevilla, Spain
        • Investigative Site
      • Zaragoza, Spain
        • Investigative Site
  • Ukraine
      • 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, Ukraine
        • Investigative Site
  • United Kingdom
      • Eastbourne, United Kingdom
        • Investigative Site
      • London, United Kingdom
        • Investigative Site
      • Worthing, United Kingdom
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GP2013
Type: Biological/Vaccine
Biological: GP2013
Type: Biological/Vaccine
Other Names:
  • no brand name available
Active Comparator: rituximab
Type: Biological/Vaccine
Biological: rituximab
Type: Biological/Vaccine
Other Names:
  • MabThera(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Time Frame: 24 weeks
24 weeks
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Time Frame: 24 weeks
24 weeks
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Time Frame: 3 years
Number of participants with progression free survival events
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
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
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
Time Frame: 24 weeks, 3 years
number of participants with confirmed positive ADA
24 weeks, 3 years
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
Time Frame: day 63

C max

For descriptive purposes only, no hypothesis testing
day 63
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
Time Frame: day 63

C through

For descriptive purposes only, no hypothesis testing
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

AUEC (0-21d)

For descriptive purposes only, no hypothesis testing
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

July 10, 2015

Study Completion (Actual)

January 22, 2018

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP13-301
  • 2010-019522-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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