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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
629

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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