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

This study is currently recruiting participants.
Verified April 2014 by Sandoz
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01419665
First received: August 17, 2011
Last updated: April 10, 2014
Last verified: April 2014
  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
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Overall response rate


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

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419665

Contacts
Contact: Sandoz Biopharmaceuticals +49 8024 908- 0

  Show 151 Study Locations
Sponsors and Collaborators
Sandoz
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01419665     History of Changes
Other Study ID Numbers: GP13-301, 2010-019522-13
Study First Received: August 17, 2011
Last Updated: April 10, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Austrian Medicines and Medical Devices Agency
Brazil: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Hungary: Ministry of Health, Social and Family Affairs
India: Drugs Controller General of India
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Instituto Nacional de Salud
Poland: Ministry of Health
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center - Ministry of Health
Italy: Ministry of Health
Greece: Ministry of Health and Welfare
Japan: Ministry of Health, Labor and Welfare
Ireland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014