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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 : October 16, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz

Study Description
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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

Detailed Description:
Previously GP13-301.
Study Design
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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
Actual Primary Completion Date : July 10, 2015
Actual Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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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)


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Sandoz
Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01419665    
Obsolete Identifiers: NCT03814785
Other Study ID Numbers: CIGG013A2301J
2010-019522-13 ( EudraCT Number )
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
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:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents