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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.
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz Identifier:
First received: August 17, 2011
Last updated: February 8, 2017
Last verified: February 2017
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
Masking: 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 ]

Estimated Enrollment: 618
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)


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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01419665

  Show 153 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Responsible Party: Sandoz Identifier: NCT01419665     History of Changes
Other Study ID Numbers: GP13-301
2010-019522-13 ( EudraCT Number )
Study First Received: August 17, 2011
Last Updated: February 8, 2017
Individual Participant Data  
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 processed this record on April 26, 2017