This trial is active, not recruiting.

Condition follicular lymphoma
Treatments gp2013, rituximab
Phase phase 3
Target CD20
Sponsor Sandoz
Collaborator Novartis Pharmaceuticals
Start date December 2011
End date December 2017
Trial size 618 participants
Trial identifier NCT01419665, 2010-019522-13, GP13-301


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Type: Biological/Vaccine
gp2013 no brand name available
Type: Biological/Vaccine
(Active Comparator)
Type: Biological/Vaccine
rituximab MabThera(R)
Type: Biological/Vaccine

Primary Outcomes

Overall response rate in patients with FL
time frame: 24 weeks

Secondary Outcomes

Percentage of patients with Adverse Events (AEs)
time frame: up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Sandoz.