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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419665
First Posted: August 18, 2011
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz
  Purpose
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 Intervention Phase
Follicular Lymphoma Biological: GP2013 Biological: rituximab Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sandoz:

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


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

Enrollment: 629
Study Start Date: December 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
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


  Show 153 Study Locations
Sponsors and Collaborators
Sandoz
Novartis Pharmaceuticals
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01419665     History of Changes
Other Study ID Numbers: GP13-301
2010-019522-13 ( EudraCT Number )
First Submitted: August 17, 2011
First Posted: August 18, 2011
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sandoz:
Follicular Lymphoma
Biosimilar
GP13-301
rituximab
Antibodies
CD20

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