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

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ClinicalTrials.gov Identifier: NCT01419665
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : February 13, 2018
Novartis Pharmaceuticals
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Biological: GP2013 Biological: rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2011
Primary Completion Date : July 10, 2015
Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: GP2013
Type: Biological/Vaccine
Biological: GP2013
Type: Biological/Vaccine
Other Name: no brand name available
Active Comparator: rituximab
Type: Biological/Vaccine
Biological: rituximab
Type: Biological/Vaccine
Other Name: MabThera(R)

Primary Outcome Measures :
  1. Overall response rate in patients with FL [ Time Frame: 24 weeks ]
    Overall response rate

Secondary Outcome Measures :
  1. Percentage of patients with Adverse Events (AEs) [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419665

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Sponsors and Collaborators
Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01419665     History of Changes
Other Study ID Numbers: GP13-301
2010-019522-13 ( EudraCT Number )
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sandoz:
Follicular Lymphoma

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents